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GMP for Warehouse
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Training Outcome of the Module:
The quality of a pharmaceutical product is defined as one that is pure, correctly
identified, effective and safe to use. Customers and patients have an ethical (and
legal) right to expect quality pharmaceutical products.
The warehouse plays a pivotal role in manufacturing quality products, as it is
responsible for all incoming goods (including labeling and packaging) and for
releasing finished products. Therefore, there are GMP rules in place to ensure
that materials are handled and stored properly, while appropriate
documentation is maintained.
By the end of this module, you will be able to:
Explain the role of the warehouse
List the GMP procedures needed in the warehouse to control incoming goods
Identify the GMP requirements for handling starting materials and finished
products in the warehouse
Recognize the GMP issues surrounding release of finished products to the
marketplace
Recognize issues around transport of goods to and from the public
Recognize how returns ore handled by the company
Identify the different documentation needed in the warehouse
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GOOD TO KNOW - GDP AND GWP
Good Distribution Practice (GDP) and Good Warehousing Practice (GWP)
are each special parts of GMP. GDP refers specifically to the transport
and distribution of the product. GWP refers to the practices specifically
within the company warehouse.
GDP and GWP each have their own legal definition end regulations.
These regulations recognize that product quality can be significantly
impacted offer manufacturing and packaging have taken place.
In this module, "GMP" for the warehouse incorporates practices, rules,
and regulations spanning GMP, GDP, and GWP.
GWP refers to the practices specifically within the
company warehouse.
GDP refers specifically to the transport and distribution of the product.
.
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Examples of government audit findings for warehouses
The top 10 GDP deficiencies listed in the table below. The results were taken
from the UK, but are indicative of the industry at large.
Description %
General storage - temperature control and monitoring 16.7
Unauthorized activity 9.6
Lack of or inadequate written procedures 8.8
Supplier status 7.9
Cold storage - temperature control and monitoring 7.9
Premises, equipment, and calibration 7.0
Cold chain transportation 7.0
Quality system and duties of the Responsible Person 5.3
Segregation of unsalable stock 3.5
Returns 3.5
Source: Orme-T (MHRA), "The Top 10 Deficiencies and Counterfeit Awareness",
22 Jan 2008
Once a finished product is received into the warehouse, it does not undergo any
further inspections or quality control tests. If the product is degraded or
damaged at this point, there is nothing that stops it from being given to the
patient. The warehouse must rely upon procedures and well-trained staff to
ensure that products arrive safely and with the same quality as when they left
manufacturing.
There have been many cases of product being affected by poor warehouse storage
conditions or rough handling on transport. Biopharmaceutical products often
have temperature-sensitive active ingredients that break down or degrade if
exposed to heat or light, thus becoming ineffective.
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What do the GMP rules say?
US FDA CFR 211:
Subpart H—Holding and Distribution
Sec. 211.142 Warehousing procedures
Written procedures describing the warehousing of drug products shall be
established and followed. They shall include:
(a) Quarantine of drug products before release by the quality control unit.
(b) Storage of drug products under appropriate conditions of temperature,
humidity, and light so that the identity, strength, quality, and purity of the drug
products are not affected.
Subpart H—Holding and Distribution
Sec. 211.150 Distribution procedures
Written procedures shall be established and followed, describing the distribution
of drug products. They shall include:
(a) A procedure whereby the oldest approved stock of a drug product is
distributed first. Deviation from this requirement is permitted if such deviation
is temporary and appropriate.
(b) A system by which the distribution of each lot of drug product can be readily
determined to facilitate its recall if necessary.
International GMPs:
Chapter 4 Documentation
Procedures and records
4.19. There should be written procedures and records for the receipt of each
delivery of each starting and primary and printed packaging material.
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Chapter 5
Production
5.5. Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing, until they
have been released for use or distribution.
Finished products
5.58. Finished products should be held in quarantine until their final release
under conditions established by the manufacturer.
Overview:
A pharmaceutical warehouse must be expertly managed and run in compliance
in order for the company to protect and distribute a quality product.
These compliant practices include control over receiving goods, quality control,
storing materials, components and products, fulfilling picking requests and
shipping the product to the marketplace. These practices must be completely
traceable in order to protect the integrity and stability of the product and its
packaging.
GMP rules for the warehouse enable manufacturers to:
protect medicines from damage during storage and transport
prevent degradation of the product by exposure to adverse temperature
conditions
avoid mix-ups and contamination by other materials
maintain product identity and traceability
prevent time-expired or damaged material or product from being used
What comes into the warehouse?
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The following goods generally do not appear on any production bill of materials,
and have a simplified check and release. Often, they do not have an in-house lot
number applied, but this varies from company to company.
non-production consumables (non-GMP material), e.g. toilet paper, stationery
production materials consumed in processing, e.g. filters, lubricants
laboratory reagents, e.g. buffers, chemicals
The last two items above will usually have their own QC approval processes.
The following goods will always appear on any production or packaging bill of
materials. They are each governed by GMP quality control and release
procedures. All these goods will be issued with unique lot numbers.
manufacturing starting materials and chemicals
packaging components, e.g. blister pack film, bottles, caps, vials, seals
printed matter, e.g. labels, cartons, inserts/leaflets, pre-printed tubes
GOOD TO KNOW - PROCEDURES FOR RECEIVING MATERIALS
When starting materials first arrive at the facility, they fall under the control
of the warehouse. Different types of materials can be treated in a number of
different ways. For example, materials consumed in production need to be
registered and checked for approved supplier and grade (pharmaceutical or
medical), but may or may not need a unique identifying number. Ensure that
you know your Standard Operating Procedures.
In the case of starting chemicals used in product formulation, they will always
need to be checked to see that they;
arrived from an approved supplier
are not damaged
are correctly labeled and identified with the supplier's lot number for
traceability purposes
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are given a unique in-house lot number
registered in inventory, and
quarantined, then sampled for release testing
Some of these chemicals may also deteriorate when exposed to heat, so they
may have to be stored under controlled temperatures, or even frozen.
Typical layout of a warehouse
Warehouses are typically classified by the types of material they contain, for
example, raw materials, packaging materials, intermediate or bulk product and
finished product. A typical warehouse will contain some or all of the areas in the
picture below.
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A quarantine area for storing goods that have not yet been inspected or tested.
Materials stored in Quarantine cannot be used or released until approved by
QC.
Some warehouses have a Dangerous Goods storage area to ensure the safety
of staff and the facility. For example, flammable goods such as ethanol would
be stored in this area. Special storage conditions, such as flame-proof
cabinets, are used here.
Some warehouses have a locked area for restricted goods, such as poisons
and drugs of addiction. This area is restricted to specifically authorized staff.
A separate area for isolating faulty or recalled goods, ensuring that they are
not issued or sold by mistake.
A "reject" area reserved for rejected batches.
The coolroom is usually operated at 2°C - 8°C so temperature-sensitive
materials (e.g. vitamins) do not deteriorate.
It is important to regularly check that the coolroom temperature is within
normal operating ranges. The coolroom usually has a quarantine and a
released area.
The sampling booth is the first place starting chemicals are opened. To protect
the material, the sampling room should have specific air controls to exclude
outside air from entering, and to contain any dust generated from sampling
to protect the environment. Sampling implements must also be clean before
use and cleaned after each use.
Pay particular attention to the air control systems, gowning and safe handling
of chemicals in this area.
A "released" area for batches that have been successfully tested and passed
for use.
A quarantine area for storing goods that hove not yet been inspected or tested.
Materials stored in Quarantine cannot be used or released until approved by
QC.
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Use of computer systems
Often, computer systems are used to control the inspection and test status of
materials and products. If computers are used, materials and products may not
need physical status labels, or even be stored in separate areas.
Inventory status control computer systems used in warehouses must be
validated for reliability and freedom from errors.
There will be strict procedures in place and security levels instituted to ensure
that information is accurately entered. You should be familiar with the security
and procedures associated with the use of these systems,
Repacking
Some raw material supply warehouses may decide to repack larger containers of
chemicals into smaller order quantities. While this may seem a simple process,
it must come under GMP controls and be accompanied by a processing record.
Repacking should be performed according to a written procedure and only by
trained staff.
What could go wrong with this repacking process?
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The labels on the smaller bags may not give exactly the same information
as the original larger pack.
The repacking may take place in a room which is contaminated with other
chemicals.
The smaller containers may not be compatible with the larger drum.
The re-packer may want to apply their company name and delete the
original manufacturer’s name.
The chemical may be hydroscopic (pick up moisture) during the repacking
process.
The chemical may be harmful to health if not handled correctly, or the
Material Safety Data Sheet (MSDS) may not be included.
Warehouse personnel and training
Warehouse personnel need to be skilled in a number of different functions,
including applying the GMP rules specific to the warehouse, just like
manufacturing personnel are trained in applying the GMP rules related to their
areas. All warehouse personnel need to be trained, even contract and casual staff
employed during peak times.
Warehouse personnel should also be trained in SOPs applicable to the
warehouse's operation.
Some examples of specific skills required relevant to warehouse personnel:
Pack and label stock so that it is protected during transport.
Interpret environmental monitoring displays such as temperature and
humidity gauges.
Be able to ensure materials and stocks are located under their correct storage
locations.
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Use safe handling procedures according to each chemical's Material Safely
Data Sheet (MSDS).
Conduct stock takes and maintain inventory records.
Accurately locate and select the right stock from pick lists and orders on a
first-fin, first-out basis.
Recognize situations where products or chemicals may be at risk, e.g.
spillage, broken pack, missing labels.
Safely operate picking machinery, such as a forklift or bay picker.
Accurately enter stock into the computer system inventory and maintain
accurate paper records.
Preventing contamination and deterioration
To prevent possible contamination or deterioration of materials during
warehousing, there are some important warehouse rules that must be followed:
No packs should be left unsealed. This prevents possible dirt contamination
from the environment or pest infestation.
All chemicals and products must be stored within their labeled temperature
zones, for example, products labeled:
- Store at 2°C-8°C.
- Do not freeze.
- Store below 25°C.
Use a first-in, first-out (FIFO) system. Chemicals and medicinal products
deteriorate over time, and generally have expiry dates. Not rotating stock
could result in partly degraded or aged materials being issued.
Follow the chemical spillage procedures to ensure that personnel and other
products are protected. Report all incidents to supervision.
Keep outer doors and exits closed whenever not in use. Outside dirt and pests
may contaminate the stock.
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Never use material or product that is either unlabelled or not correctly
labeled. If a label is missing, it generally means the stock should not be used.
Preventing mix-ups in the warehouse
In a busy warehouse, there is daily movement of starting materials into the
warehouse, daily pickups from production, regular storage of in-process bulk
goods, incoming finished products, and release of finished stock to distributors.
Space is often limited, and many warehouses can become overcrowded.
During all this movement of stock, staff have to maintain records, and sometimes
apply labels to indicate status.
As there are opportunities for mix-ups to occur on an almost daily basis, so too
are there GWP rules that help prevent these from happening:
Quarantine inward goods and finished goods until they are approved for
release.
Segregate material by their status labels (e.g., there should be only released
labeled stock in the released store).
Ensure that Unique Identifying Numbers and batch numbers are clearly
visible and legible.
Wherever possible, ensure that only one type of material is stored in one
location. (Note: Different companies may have different views on this.)
Why have material and product segregation?
One of the keys to ensuring that only the correct materials or products are
released is to practice good physical segregation and/or validated electronic
segregation. In the case of defective and recalled goods, it is essential to have
both physical and electronic segregation.
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PHYSICAL SEGREGATION
It is a GMP/GWP rule that goods with different
statuses be physically located in different and
designated areas if a validated computer system
is not used to control location. (Some companies
also use physical segregation even when they
employ validated computer systems.)
Physical segregation minimizes the chance of
someone accidentally selecting and using the
wrong material.
Always double-check the status of the item and
its location before selecting it. If the selected lot
is in a quarantine or reject location, refer the
error to your supervisor.
ELECTRONIC SEGREGATION
Many warehouses control their inventory by the
use of an MRP computer system. The computer
system must be validated (be 100% reliable) and
only allow access to authorized personnel.
Generally, warehouse computer systems are
used to:
register inward goods and their quantities, lot
numbers, expiry dates, suppliers, and assign
their status (e.g. Quarantine)
change the status of a lot or batch
depending on the status of the lot or batch,
allow or disallow planners and dispatchers
from selecting goods electronically
track inventory movement to specific
allocated locations in the warehouse so that
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only the right material or product can be
selected for use or release
provide an accurate history of stock
movement to allow for stock takes and
traceability
In summary, the warehouse computer system
serves a critical function, and staff required to
use it must be fully trained in its use. In
addition, staff should never share their
passwords with other staff, nor log on or off other
personnel.
GOOD TO KNOW - SEGREGATING SUSPECT OR DEFECTIVE MATERIALS
Warehouse personnel have to deal with materials and products that may have
different statuses, or may change status during storage. Some materials and
products may actually be damaged or defective, and staff need to isolate these
from good stock.
The following non-routine, suspect or defective goods may be encountered in
the warehouse:
damaged goods from stock
returned goods from customers
recalled goods
counterfeit products
"Not for Sale" samples
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A fundamental GMP control is to ensure that only approved starting materials
that meet specifications are used to formulate medicines. Patient safety depends
on it. Removing the protection of status controls will raise the risk of an error
occurring.
The government regulatory agencies and their auditors are very aware that lack
of control over material movement in the warehouse can, and has, led to defective
product. For this reason, they regularly conduct inspections of the warehouse
and the warehouse procedures to ensure that GMP rules are in place.
What do the GMP rules say?
US FDA CFR 211
Subpart H~Holding and Distribution
Sec. 211.142 Warehousing procedures.
Written procedures describing the warehousing of drug products shall be
established and followed.
They shall include:
(a) Quarantine of drug products before release by the quality control unit.
(b) Storage of drug products under appropriate conditions of temperature,
humidity, and light so that the identity, strength, quality, and purity of the drug
products are not affected.
International GMPs
Chapter 5
Production
5.40. The purchase, handling and control of primary and printed packaging
materials shall be accorded attention similar to that given to starting materials.
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5.41. Particular attention should be paid to printed materials. They should be
stored in adequately secure conditions such as to exclude unauthorized access.
Cut labels and other loose printed materials should be stored and transported
in separate closed containers so as to avoid mix-ups. Packaging materials should
be issued for use only by authorized personnel following an approved and
documented procedure.
Chapter 3
Premises and equipment
3.18. Storage areas should be of sufficient capacity to allow orderly storage of
the various categories of materials and products: starting and packaging
materials, intermediate, bulk and finished products, products in quarantine,
released, rejected, returned or recalled.
Overview
Preventing contamination and mix-ups of materials and products are the main
focus of GMP in the warehouse.
Some general rules to prevent contamination and mix-ups are:
Materials must be purchased only from approved suppliers to written
specifications.
All incoming materials must be placed into quarantine.
Quarantined materials must be inspected and/or tested to verify their
suitability for use.
All materials must be labeled clearly to indicate their inspection and test
status.
Materials must be stored safely to protect from deterioration and damage.
Records must be maintained for all issued material in order to ensure
traceability.
GOOD TO KNOW - CONTAMINATION
Contamination refers to the presence of any foreign substance in a product.
It may be:
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physical, e.g. foreign objects, dirt, dust, pollens
chemical, e.g. cleaning agents, lubricants, impurities, degradation products
microbiological, e.g. bacteria, moulds, spores, yeasts
Housekeeping
A key to a successfully operated warehouse is good housekeeping. The
warehouse is generally a very busy place, with constant movement of inventory
in and out, as well as to different warehouse locations internally.
Good housekeeping, which essentially means "Everything in its place",
minimizes the opportunity for mix-up of goods, reduces the possibility of
dispatch or issue of incorrect goods, and improves warehouse safety.
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Pictured here is on area specifying a no-walk zone. Forklifts are constantly used
in this area, and are potentially dangerous. In addition to good housekeeping,
warehouse personnel should pay attention to safety rules, including what type
of safety clothing that should be worn.
Material identification information
Each separate material received should be labeled with a standard name and a
Unique Identifying Number (UIN). These are used throughout storage and
processing to identify that material. In order to prevent confusion with product
batches, the UIN is generally not called a batch number, and should not be the
same as the supplier's lot number.
Supplier's batch number
Within each delivery, containers bearing different manufacturers' batch or lot
numbers should be separate. This will help trace any contamination or other
problem back to a supplier's batch and make it easier to isolate the finished
product containing suspect material.
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Each group bearing the same batch, lot, or equivalent number in a single delivery
can be regarded as the same material. Subsequent deliveries of the same
manufacturer's batch or lot number should also be regarded as separate
materials, since the handling and transport may have affected their quality.
Standard name
The standard name refers to the unique approved name listed in the company's
standard names register. The standard name is the same one that is used in the
product formulation bill of materials. For example, sodium chloride can also be
generically called salt or sodium salt. Standardizing the name internally
eliminates any confusion.
The term "USP" refers to the grade or quality of the material. Generally, chemicals
will be labeled "USP", "BP", or "EP" grade to indicate that they ere pharmaceutical
grade.
Material item code
The material item code is linked to the Standard Name, and is used in the Master
Batch Record and formulation. This code also corresponds with the barcode, and
usually helps identify the approved supplier and grade of the material.
UIN (Unique Identifying Number)
The UIN (Unique Identifying Number) is alternately called the Goods Inward
Number (GIN), lot number, or batch number. The number is critical because it
uniquely identifies and allows traceability of that consignment of material. The
UIN is recorded in the laboratory, on the computer system, and in production
when a product is formulated.
Expiry date
The expiry date indicates the date after which the goods cannot be guaranteed
to be safe for use. Clearly, once goods have expired, they must be placed in reject
areas and not used.
Storage conditions
Materials and products can degrade if not stored under the approved storage
conditions. For finished products, storage conditions are registered with the
government, meeting it a legal requirement to store them in compliance.
Barcode
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Some companies apply a unique barcode, providing a second unique identifier
for the material a product. The barcode is used to electronically scan the identity
of the item before issue.
Status labels
In addition to the identification information, each lot requires a status label, so
that the status of any material is evident. Some examples of physical status
labels are below. Note the use of the different colors. (Note: Different companies
may have different colors for the types of status labels used.)
Status labels may be either:
physical labels on the container
electronic fields on a database
combination of physical and electronic
Be familiar with the system your company uses to ensure that only released
materials are used.
Before any lot may be used in manufacturing, it must be released for use QC.
Once a lot has passed inspection and testing, QC will change the status from
"Hold"/"Quarantine" to "Released"/"Approved".
STATUS LABELS
This label is used when the goods have not yet been
tested and released for use by the laboratory.
Materials labeled Quarantine should not be used.
The Hold label indicates the material may have a
problem and is under investigation. Do not use
under any circumstances.
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The Released label indicates the material is suitable
for use or released for supply. The batch has been
tested and cleared by the Quality Department.
The Approved label indicates the material is
suitable for use or released for supply. The batch
has been tested and cleared by the laboratory.
The Rejected label indicates that the batch has been
assessed as unacceptable or defective. Never use
these materials. They should be located in separate,
locked area.
Control of product labels
The control of product labels is a crucial port of GMP, since customers may be
adversely affected by mislabeled product. All product labels must therefore be
strictly controlled. Some of these controls include:
Each different type of label is clearly identified and segregated in the label
store to prevent mix-ups.
Access to the label store must be restricted to authorized personnel.
There should be no loose approved or released labels in the store.
Any unused or damaged labels should be returned to the Quality Department.
"Approved" or "Released" labels should only be issued by the Quality
Department.
Before the release of labels, they must be checked and double-checked
against the work order to verify the:
- product name and code
- label identity and version number
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- coded batch number and expiry date
Only when all the checks have been satisfactorily completed can labels be taken
into the packaging area.
GMP storage requirements
Staring materials and components must be stored in designated locations,
GOOD TO KNOW - SPECIAL STORAGE REQUIREMENTS
Some materials are required to have additional safety and security procedures.
For example, the following goods must be locked up or otherwise secured from
unauthorized access:
printed packaging materials
drugs of addiction, antibiotics, and highly potent drugs
poisons and flammable goods
rejected and recalled materials
returned goods
Keep powders, liquids, and corrosive and flammable materials separate.
Dangerous goods areas should be specially equipped to prevent contamination
and spills.
Keeping the warehouse Clean
GMP rules state that warehouses storing raw materials, components, printed
matter, and finished goods must be kept clean, dry, and orderly at all times.
This involves, but is not limited to:
protecting receiving areas from the weather
checking regularly to ensure that containers and packs are sealed properly
cleaning the facility regularly
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cleaning up spills immediately
The exterior of inward goods containers may also need to be cleaned before
storage.
Protecting goods from deterioration
To protect goods from deterioration:
Store goods at the temperatures specified on their labels.
Monitor and alarm freezers and refrigerators.
Monitor temperatures in other areas where goods requiring specific storage
conditions are being stored.
Review all records; analyse and file as appropriate.
Investigate all deviations and assess their impact on product suitability.
Protecting raw materials
Because raw materials may deteriorate on storage or become contaminated if
stored incorrectly, the storage conditions are critical to product purity. In order
to protect raw materials, there are some specific and important GMP rules
relating to this:
Separate quarantine and reject areas.
The storage environment should be temperature-controlled.
Store goods off the floor and away from walls.
Employ a system that identifies material about to expire, so that it can be
retested if necessary.
Periodically inspect stockrooms for past-expiry or expired stock, cleanliness,
housekeeping, and pest control.
Seal over all opened containers to protect from the environment.
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Ensure that there is a cleaning program for each separate area in the
warehouse, including for external areas, gangways, shelving, and racking.
Pest control
Some of the pests that are attracted to pharmaceutical warehouses include rats,
mice, birds, ants, and cockroaches. For example, stored goods can be
contaminated by bird or rodent droppings. Therefore, GMP rules require that a
manufacturing facility has:
a nominated pest control officer
specific instructions or agreements with pest control companies
maps showing bait locations
documentation of all pest control treatments
having frequent waste collections
WHAT AN EFFECTIVE PEST CONTROL PROGRAM INVOLVES
Environmental regulations and OH&S also require companies to protect
personnel and the surrounding environment from the chemicals used in pest
control programs.
An effective pest control program involves:
keeping track of any sightings of pests between visits by the pest control
companies
assigning someone to accompany the pest control agent when they are on
site
using only approved pesticides
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Air control in the warehouse
The warehouse links the outside environment to the inside production facility.
Therefore, the warehouse becomes a barrier to prevent dirt, dust, particles,
moisture and pests from entering the building.
In order to separate the inner production area from the outside, warehouses
generally have specific designs, and rely upon employees keeping doors shut
wherever possible.
Outside Air
The outside air is of course not controlled in any way. If the factory is left open,
wind will blow contamination into the factory, so it is important that the outer
door is kept shut when not in use. The outer door provides the first point of
protection for the warehouse and the production area.
Receipt Area
This is where goods are unloaded off the delivery truck and assessed before being
brought into the warehouse. Notice that this area has an outer roller door and
an inner curtain in order to prevent outside dirt or dust from entering the
warehouse. An important GMP rule is to not have both the outer roller door and
the inner barrier open at the same time. This area is sometimes referred to as a
"black" zone.
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This area is also the first point where outer bags and cartons are cleaned down,
so that minimal dirt is transferred to the warehouse itself. If goods are unclean
or damaged, they should not be sent into the warehouse.
Warehouse
The warehouse itself is not pressure-controlled, but is cleaner than the receipt
area. In the warehouse, goods should be stored off the floors and away from
walls, because moisture may be taken up through concrete walls and floors. This
area is sometimes referred to as a "grey" zone since it is cleaner than outside,
but still not clean enough to expose products to the environment.
Production Area
Some companies refer to the production area as a "white" or "clean" zone, where
only cleaned materials may be taken. Generally, goods transported to this area
are on plastic pallets, since wooden pallets cannot be cleaned and can harbor
fungus, mould, and bacterial contamination. The production zone is pressure-
controlled to provide an air barrier to dirt and particles entry. In order to
maintain positive pressure, it is critical to keep the doors between the production
and warehouse areas closed.
Before materials are taken into the production area, the outer cartons that had
arrived on the truck are generally removed, where possible, as an added
precaution. Most companies also have different dress codes when moving from
a grey zone to a white zone.
Importance of storage temperature controls
Temperature storage controls are important in the warehouse in order to ensure
product integrity throughout the product's shelf life. Medicinal products
damaged by exposure to extremes of temperature may escape detection,
resulting in physical damage and/or loss of therapeutic effect. Worst of all, it
may not be obvious at all.
For temperature-controlled warehouses, companies are expected to create a
temperature map of the facility. The map is used to identify the best places in
the warehouse to store goods. An initial study when creating this map will reveal
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where problems would most likely be encountered, e.g., storing goods against
north-facing walls, close to room heaters, close to windows or near the roof.
After initial mapping, temperatures are routinely monitored on a continuous or
daily basis. This monitoring may reveal seasonal patterns where temperatures
may rise or fall outside approved limits. It is important, then, to continue to
review temperature profiles in the warehouse over time, particularly during
summer and winter. Some companies monitor using an electronic building
management system.
AMBIENT TEMPERATURE STORAGE
The terms "room" or "ambient" temperature storage conditions have different
meanings to different companies and different regulators. It is now more
common the use the term "temperate" storage. Temperate storage has recently
been redefined as a storage temperature of between 15°C and 30°C, with
occasional excursions above that range.
Temperate storage controls vary from product to product, however, many
licensed products stipulate an upper limit of 25°C with no lower limit apart
from "protect from freezing". Inspectors have indicated that 8°C to 15°C is
acceptable temperate storage.
ADDITIONAL REQUIREMENTS FOR TEMPERATURE CONTROL
The conditions of storage for the goods should be compatible with the
storage conditions specified on their labels.
Controlled storage environments should be monitored, using suitable
temperature recording devices. All records should be reviewed and filed,
with their results tabulated and analyzed.
Refrigerated and freezing storage environments should be fitted with both
an alarm and a visual signal. This signal should permit resetting only by an
authorized person,
If any temperature is found to have deviated outside the relevant
recommended conditions for an extended time, the manufacturer of the
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goods should be contacted and the suitability of the product for use
resolved.
Equipment used for monitoring temperature should be calibrated on a
regular basis to ensure their accuracy.
How to create a temperature map
A simple temperature control example involves the physical location of material
storage in the warehouse. The higher up in the warehouse a material is stored,
the hotter the temperature the goods will be exposed to, so a physical space
nearer the ceiling without temperature controls will be inappropriate to store
goods that need to be kept cool.
Study the temperature profile of the premises, and identify potential "hot"
and "cold" areas.
Study the areas of greatest potential risk using calibrated temperature and
humidity monitoring instruments.
Develop a temperature mapping validation protocol.
Based on initial findings, commence monitoring on a regular basis.
Produce a temperature map of the premises.
Review the hot and cold areas when outside temperatures are extreme, for
example, in summer and winter.
Review the controls of heating and cooling systems.
Ensure an action plan exists in the event of temperatures becoming
compromised.
Cold storage
Cold storage refers to the storage of products requiring a storage temperature of
2°C-8°C, or when material is required to be stored frozen (e.g. below -20°C or
below -70°C).
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For a successful cold storage operation, the facility must select the right
temperature recording instrumentation, validate its processes, and maintain
documentation of records and procedures, including responding to alarm
conditions.
INSTRUMENTATIONS
The selection of recording instruments is vital. The
instruments must be easily read, and the data
must be retrievable. The instruments must be
calibrated to a national standard (the company
should retain a copy of the calibration certificate
for the equipment), and a high/low temperature
alarm should be incorporated. Max/min
thermometers are usually not acceptable.
Both air and product temperatures should be
recorded. Note that air temperature can fluctuate
considerably more than product (often called
"load") temperature.
VALIDATION
Validation efforts must:
Prove that temperature mapping checks for
areas of extreme temperatures.
Check on temperature variations during use.
Demonstrate performance in the event of a
power failure.
Demonstrate the function of alarms.
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DOCUMENTATION
Specific procedures that need to be incorporated
include:
checking temperature records at the start of the
waking day, and recording these checks in a log
what to do when certain staff are absent
responding to alarm conditions
When reviewing the cold storage controls, a
program should be set up to review cold store
temperature records both weekly and monthly as
part of a self-inspection program.
RESPONDING TO ALARM CONDITIONS
Out-of-hours alarm signals are often sent to
remote contractors or security offsite. It's therefore
very important to ensure the alarm system is
operating reliably, as repeated false signals may
result in a real signal being ignored. There are
many industry examples of degraded stock due to
late or no response to electrical failures in
warehouses. The alarm system should operate
independently of the main electrical system.
There must be a written procedure on how to respond and who to inform when
a temperature alarm monitor signals a problem. This procedure should cover
initial action (e.g. quarantining the cold store) and subsequent action. There
should be an available and current list of emergency numbers to call, and there
should be a backup plan to relocate any products are risk of deterioration (e.g.
frozen stock). Any response must be immediate, so the procedure should
ensure that weekends are addressed as well.
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Protecting sensitive materials
Many companies (particularly companies manufacturing biologicals and
vaccines) handle, store, and transport temperature-sensitive raw materials and
finished products. The protection of temperature-sensitive products is critical to
their effectiveness and safety.
Products can be degraded by excessive heat, moisture, light or repeated
freeze/thawing cycles.
STATUS LABELS
Freezers
Frozen materials are usually stable at -20°C and below,
though some materials require freezing at -80°C. If the
temperature rises, it will probably do so slowly over
several hours. Once the temperature rises above a
certain point, some to the frozen materials will start to
deteriorate or degrade. There must be a written action
plan that includes a contingency for relocation if the
temperature continues to rise.
Automatic defrost refrigerators
Some cold storage refrigerators have an automatic
nightly defrost cycle, these refrigerators may not be
suitable, as many frozen products can partially melt
then re-freeze, causing them to deteriorate and
degrade.
Heat and moisture
Almost all medicinal products are sensitive to heat and
will degrade at higher temperatures. Some products will
degrade at room temperature, while others can
withstand temperatures above 30°C for prolonged
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periods. It is practically impossible to know which
products are at risk or degrading at which
temperatures.
All products must undergo stability studies to prove
that they will not degrade under the approved storage
conditions.
GMP rules require that products be only stored within
approved temperature ranges. If the product is exposed
to excessive heat, a deviation notice should be raised.
Some products may absorb moisture from the
atmosphere it they are not properly sealed. One of the
main causes of moisture problems comes from
incorrect storage of products directly on concrete floors
and walls, as the product packaging can absorb
moisture from these surfaces.
Light
Some products are "photolytic", that is, they may
degrade it they are exposed to light for prolonged
periods. Be alert to packages that state "Protect from
light" and ensure that they are completely sealed.
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Many mis-formulation incidents commence with the wrong issue of starting
materials or other chemicals from the store.
The GMP rules clearly state that each issue of starting materials from the store
must be accompanied by requisition paperwork and that there is a cross-check
that issues match the documented request before being issued.
The reason for this requirement is that material issue is the first point of control
inside the factory. It is much better to prevent incorrect chemicals being issued
in the first place rather than finding them (or not) later on. Mis-formulation can
cause patient medication to be unsafe, which can result in serious injury or even
death of patients.
What do the GMP rules say?
US FDA CFR211
Subpart B—Organization and Personnel
Sec. 211.22 Responsibilities of quality control unit. (extract)
(a) There shall be a quality control unit that shall have the responsibility and
authority to approve or reject all components, drug product containers, closures,
in-process materials, packaging material, labeling, and drug products, and the
authority to review production records to assure that no errors have occurred or,
if errors have occurred, that they have been fully investigated, The quality control
unit shall be responsible for approving or rejecting drug products manufactured,
processed, packed, or held under contract by another company.
International GMPs
Chapter 4 Documentation
Procedures and records
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4.19. There should be written procedures and records for the receipt of each
delivery of each starting and primary and printed packaging material.
Chapter 5 Production
5.5. Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing, until they
have been released for use or distribution.
Finished products
5.58. Finished products should be held in quarantine until their final release
under conditions established by the manufacturer.
Overview
One of the most important aspects of GMP is to ensure that the right raw
materials are received and that the correct raw material batch is issued to
production to commence manufacture.
Mistakes in this activity can have significant consequences for patient safety, or
cause batches to be rejected. Therefore, the utmost care must be taken when
receiving, logging in, storing, and issuing of raw materials.
STEPS INVOLVED BETWEEN RAW MATERIAL RECEIPT AND ISSUE
Receiving:
GMP commences on receipt of the raw materials
from the supplier. Raw materials must be checked
that they are intact, have been provided according
to the paperwork, and that labels identifying name,
batch number, and expiry date ere present.
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Sampling and testing:
Laboratory sampling and testing confirm that the
raw material received meets the company
specifications for quality. There are specific GMP
procedures for sampling of raw materials to protect
the sampler and to protect the batch from
environmental contamination.
Status labeling:
On initial receipt, raw materials should be labeled
"Hold" or "Quarantine", and once they have passed
QC testing, raw materials should be re-labeled
"Released" or "Rejected". It is important that the
storage location matches the status of the raw
material. GMP requires that only "Released" raw
materials may be used in production.
Storage:
When raw materials are stored, they may
deteriorate if they are exposed to elevated
temperatures, moisture, or are stored directly on
the floor, or are in contact with walls. GMP requires
that only authorized personnel are allowed to
remove raw materials from storage.
Issue:
Raw materials are issued against documentation or
requisitions provided by the company. GMP
requires that all issues of raw material are
accompanied by the correct paperwork, so that
there is no potential for mix-up. Incorrect selection
of a raw material may result in significant problems
in manufacture, or put the patient at risk.
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Receiving materials
Direct control over product quality begins when the starting materials first arrive
at the inward goods receiving bay.
There are a number of GMP controls that need to be put in place when goods
arrive into the receiving store, which include:
Separating receiving areas from storage areas.
Protecting receiving bays from the weather.
Checking that the identification is exactly the same on the container as it is
on the paperwork.
Examining each container and verifying that containers are sealed,
undamaged, and dean.
Raising a non-conformance notice before accepting the material if any
problems arise.
Rejecting raw materials when the contents are exposed.
Identifying products needing special storage (e.g. narcotics, temperature-
sensitive products) and dealing with them immediately.
APPROVING SUPPLIERS
Pharmaceutical companies are required to maintain an approved supplier list,
and starting materials may only be purchased from supplies on this list. When
the shipment and paperwork arrive off the delivery truck, the receiving person
should check that the supplier is on the approved list. Shipment from non-
approved suppliers must be set aside and notified to supervision immediately.
Some of the factors that contribute to a supplier being approved are:
completion of a supplier questionnaire
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successful purchasing and QA supplier audits
laboratory verification of quality by testing samples
provision of an authentic Certificate of Analysis (C of A) verified by the
laboratory.
on-time delivery
For a supplier to remain on the approved supplier list, they must have a good
history of acceptable deliveries (e.g. 3-5 consecutive approved consignments).
DURING RECEIVING MATERIALS
STEPS TO CHECK DURING RECEIVING MATERIALS
Chemical name:
Many raw materials have similar and sometimes
confusing names. For example, "Ergotamine" can be
confused with "Ergometrine", which are two very
different drugs. Similarly, the same item can be
called by different names by different suppliers, for
example, "sodium chloride" can be called "sodium
salt".
Pay particular attention to the names of the
material being delivered. Sometimes a supplier can
mix up a delivery and send the wrong raw material
with the right purchase order.
Always double-check the name of the product
needed against the paperwork of the supplier.
Standard Names Register:
GMP rules requires companies to have a Standard
Names Register matched to a unique standard
company item code. The purpose of this is to ensure
that everyone in production uses the same
terminology to avoid confusion. These names and
codes should match the Master Bill of Materials.
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When labeling starting materials, always use the
company standard name and matching code.
Approved supplier:
The purchasing department usually only purchases
from QA-approved suppliers, but occasionally there
may be a mix-up.
Always double-check the supplier origin to make
sure that the supplier is on the approved supplier
list before accepting the delivery.
Grade of material:
Purchasing department only purchases QA-
approved grades of chemicals, such as USP, BP or
EP graces. The grade should be printed on the
supplier label next to the name.
Double-check the grade against the purchase order
and supplier paperwork before accepting the lot.
Multiple lots on one delivery pallet:
Sometimes, different lots of the same material or
different materials arrive on the same suppliers
pallet. Often, the outer containers look alike as well.
This can be confusing.
Always double-check each container and physically
separate them from other lots, even of the same
material on receipt. Make sure that different lots are
not mixed up, because it is unlikely that this
problem will be picked up later in production.
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The Material Data Safety Sheet (MSDS)
An MSDS is provided by the supplier, and is designed to provide both workers
and emergency personnel with the proper procedures for handling or working
with a particular substance.
MSDSs include relevant information for the GMP warehouse on:
Health effects and first aid
Storage
Disposal
Spill/leak procedures
The MSDS is meant for:
Employees who may be exposed to hazards or who need to know the proper
methods of storage
Emergency responders (firefighters, hazardous material crews, emergency
medical technicians, emergency room personnel)
For safety responders, therefore, it is important for warehouse staff to be
cognizant of the materials coming into and going out of the warehouse.
Storing received materials
After receiving the material there are some essential GMP tasks that should be
undertaken before storage:
Remove the supplier's status labels.
Apply the company's identification and status labels.
Record the receipt of goods on company documentation.
Quarantine materials immediately after they have been accepted.
Check and process goods as soon as possible to help prevent material mix-
ups and damage.
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Only in rare circumstances should quarantined materials be used in production.
If this is to happen, there must be very strict controls in place in case of a recall.
Receiving printed matter
When dealing with starting materials, direct control over product quality begins
when the starting materials first arrive at the inward goods receiving boy.
The same principles apply when printed matter arrives at the manufacturer.
Inward goods must ensure that the right printed matter is received, so that the
correct printed matter is eventually released to the packaging area. When the
printed matter arrives from the printers, it must be given its own UIN, and then
be placed into quarantine.
Following receipt and quarantine, printed matter is examined and verified by QC
against standard specimens and specifications, in order to avoid any mix-ups or
errors. Since many labels, cartons, and leaflets look alike, it is important that
QC personnel take particular care in both sampling and testing. Packaging and
labeling samples should not be returned to inventory.
Only after printed materials have passed inspection should they be released for
use.
GOOD TO KNOW - SAMPLING PLANS FOR PRINTED MATERIAL
Sampling plans are used by QC in order to specify the number of samples of
printed matter to be taken. There are several types of sampling plans QC use,
e.g. statistical, targeted, and zero acceptance number Although QC use all of
them for printed matter in some respects, the reasons why each are chosen is
beyond the scope of this module.
Suffice it to say, sampling plans for printed matter account for at least the
following:
the quantity and quality of printed matter received
the quality of printed matter required
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the nature of the material (e.g. primary and/or printed materials)
the production methods
an audit of the printed matter supplier
RECEIVING PRINTED MATTER
Arrival:
Roll labels must be counted either on receipt or at
issue
Supplier counts are not acceptable unless the
supplier is specifically qualified and supplier
certifies the exact count for each roll.
Supplier numbering of labels is an acceptable
alternative.
Cut labels must be counted and effectively verified
by the manufacturer because of the risk of mix-up.
Quarantine
Printed matter must be quarantined from use until
it has been thoroughly quality-controlled.
Quarantining involves placing the received material
into a locked, separated store, secure from
unauthorized access.
All personnel, when they handle printed matter,
should double-check that the "Quarantine" label
has been replaced by an "Approved for use" label.
If it hasn't, do not use the printed matter.
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QC
Printed matter must undergo QC inspection in the
same way as starting materials.
Each company will have specific sampling plans for
different printed matter, e.g. labels, product
information leaflets, cartons.
Printed matter samples are compared directly to
official, company-approved sample standards.
During inspection, printed matter must be stored
in quarantine and not issued for use.
Printed matter must be released by the inspection
team, and status-labeled "Approved" before it can
be used.
Issue of materials
The issue of approved materials must be performed only by designated staff.
Other staff should never "help themselves". If an incorrect materiel is issued, a
disaster such as a mix-up or product failure may follow.
Here are some important GMP rules regarding issue:
Materials should only be issued from the store by authorised persons
following a written procedure.
Records of the quantities receipted into stock and the quantities issued to
manufacturing must be maintained.
Inventory records should be maintained in such a way that any discrepancy
between the quantity received and the quantity issued can be clearly seen.
Discrepancies are to be reported and investigated.
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It should also be noted that when transferring goods from the warehouse to
production, all goods must come off wooden pallets and onto plastic pallets.
GOOD TO KNOW - COMPUTER CONTROL OF RELEASE
GMP allows for a computer system to control status and allow release to
manufacturing. If computer systems are in use, they must be validated and
secure. Ensure that you know your computer system procedures and security
controls.
Only QA- or QC-nominated personnel can change the status of material to
"Released", but every company has specific GMP rules in this area.
Stock rotation
GMP rules require that starting materials, printed matter and primary packaging
be rotated, so that materials that may be time expiring or degrading are not left
in the store for use. Companies are required to practice a "FIFO" policy. FIFO
(first-in first-out) traditionally means the first stock that arrives is the first stock
picked for use. In practice, many companies actually use "FEFO" (first-expiry,
first-out), implying that the materials with the shortest expiry must be used first.
For finished product, the FIFO principles also apply. Customers often will reject
stock that has a short-dated expiry.
Warehouse staff should be aware of this policy and follow the company's written
procedures. When selecting stock, always check its expiry date to ensure FIFO
principles are adhered to. It in doubt, refer to management.
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GOOD TO KNOW - MONITORING STORED MATERIALS
Starting materials should be retested or re-examined after long storage or after
exposure to adverse conditions. Stored starting materials may not be used for
extended periods. If stored correctly, under controlled temperature conditions
they will be good through to expiry date.
Sometimes, the laboratory will want to retest materials before continuing use.
This is usually a precaution for materials that could, for example, pick up
moisture on storage.
Rejecting defective and expired materials
Starting materials and packaging materials may not meet qualify standards on
receipt, or may reach their use-by date ("time expire") during storage. GMP rules
require that there are written procedures for the handling and rejection of
materials that are defective or have time-expired.
GOOD TO KNOW - EXPIRING STARTING MATERIALS
It is not uncommon for starting materials and finished products to reach their
use-by date. Many companies have specific rules about only releasing finished
product that has, for example, over 50% of its shelf life remaining, because
customers may reject it as having too short a shelf life.
Companies also have rules regarding the receipt of "short-dated" starting
materials. Management should be alerted if incoming goods have, for example,
less than 75% of their expiry period left, Check your company procedures
regarding this policy. GMP rules then require that the expired stock be securely
disposed of, so that there is no chance it finds its way back into manufacturing
or onto the market. There should be specific secure disposal procedures in
place to control this activity.
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On rare occasions, subject to strict QA approvals, permission may be given to
extend the expiry of starting materials, provided they meet retesting by the
laboratory.
Overview
Customers of pharmaceutical products expect to receive a product that is not
only manufactured and packaged correctly but also one that arrives in good
condition. Warehousing, transport, and distribution procedures play a vital part
in protecting the product all the way to the customer.
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Release to Quarantine
After manufacturing, the Packaging Department checks that all the batch
documentation is complete and accurate, and the product has been correctly
packaged and labeled.
The batch is then assigned to the Quarantine area in the warehouse.
QA clearance
GMP rules require that Quality Assurance conduct a final audit or clearance of
the manufacturing and packaging records. This is to independently verify that
the product has been correctly manufactured, packaged and tested.
If there are any questions or unresolved issues with a batch, QA will hold up
release of the batch until these remaining issues are closed out.
Preparation for dispatch
The warehouse team will receive a picking or dispatch order for either the whole
batch or for smaller portions of the batch. At this time, it is critical to cross-
check the order against the batch details. If any batch still in the Quarantine
store is picked, supervision should be notified immediately.
Prior to shipment, the order must be protected from possible transport damage
or deterioration (e.g. addition of outer packaging, shrink wrap of pallets, labeling
of transport temperature conditions).
Preparation for transport
After QA has officially released the finished batch, it may be moved from the
Quarantine to Released store (and labeled as such), making it ready for dispatch
to other warehouses, hospitals, distributors, or retail outlets.
Transport
The quality of the product can be affected by incorrect transport. The product
may be damaged if it is not protected from rough handling or adverse
temperature conditions. Some product may also be sensitive to vibration,
changes in atmospheric pressure, or freezing or thawing.
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Release and distribution Process flow
Preparation for dispatch
Things can still go wrong in the warehouse even after the batch has been
successfully manufactured, packaged, and sent to the Finished Goods area for
release. For example, goods may inadvertently be released before they are
officially passed by QA, or they might be physically damaged in the warehouse,
they can pick up moisture or dirt, or they could be dispatched to the wrong
customer.
Worse still, goods that were returned from the marketplace because they were
defective may unintentionally be placed back into stock without quarantining
and checking by QA.
Some things to be aware of when preparing to dispatch product include:
When dispatching, goods must be checked and double-checked against the
paperwork. Check the authorization on the requisition, the released status,
the item name and code, and the integrity of the container.
Only the right quantity of the right products should ever leave the warehouse,
Manufactured correctly
Packaged correctly
Production release
Pass laboratory testing
Pass batch record audits
Quality release
Available in released
warehouse
Protected & packaged for distribution
Warehouse release
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Ensure that the oldest material is issued first (FIFO).
Maintain appropriate dispatch records to ensure that each lot of product can
be recalled if necessary.
GOOD TO KNOW - DISPATCH RECORDS
Invoices or packing slips should be issued for each delivery and should
accompany the goods.
Records should be maintained in such a way that they are clear and readily
available. Records should show the receipt and disposal of all products
purchased and sold.
Distribution records should be kept in a form which is accessible to the
regulatory authorities.
STEPS TO CHECK DURING RECEIVING MATERIALS
222
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Pick and pack
When picking and packing finished product, there are several checks of the
product against the paperwork that need to be made.
Verifying the correct customer
Verifying the product and strength
Cross-checking the dispatch order batch number
Verifying the product is within expiry
Verifying the dispatch order quantity
Ensuring that packing instructions are correct
Transportation
Things can go wrong during transportation and distribution. For example,
product may be counterfeited or substituted in the distribution chain, or it could
be damaged by the environment in which it was transported. These situations
may cause the product to degrade or otherwise lose quality.
GOOD TO KNOW - VALIDATION OF TRANSPORTATION CONDITIONS
Many companies validate their transport conditions to see if there is are
potential problems with long-distance transit. Once conditions are validated,
it is normal practice to include continuous temperature monitoring devices on
all consignments that are moved long distances, particularly if they have any
sensitivity to heat or cold. These monitoring records are then used to check
that there were indeed no transport issues, keeping the product safe
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Once a product leaves the control of the warehouse, it is subject to the possible
impact of transport mistakes and uncontrolled warehouse conditions. Many
medicines can degrade if heated or frozen even for short periods of time. These
issues particularly apply to biological products, vaccines and products that are
labeled: "Store 2°C - 8°C. Do not freeze."
For example, product that is required to be stored at 2°C - 8°C may degrade if it
was stored at more than 1 S°C for any period of time. If the product was frozen
and then thawed, it would be very hard to detect this physically, and it may make
the product unusable.
GMP rules require that returns be assessed formally before any decision is made
to return them to stock.
What do the GMP rules say?
US FDA CFR211
Subpart K-Returned and Salvaged Drug Products
Sec. 211.204 Returned drug products.
Returned drug products shall be identified as such and held. If the conditions
under which returned drug products have been held, stored, or shipped before
or during their return, or if the condition of the drug product, its container,
carton, or labeling, as a result of storage or shipping, casts doubt on the safety,
identity, strength, quality or purity of the drug product, the returned drug
product shall be destroyed unless examination, testing, or other investigations
prove the drug product meets appropriate standards of safety, identity, strength,
quality, or purity. A drug product may be reprocessed provided the subsequent
drug product meets appropriate standards, specifications, and characteristics,
Records of returned drug products shall be maintained and shall include the
name and label potency of the drug product dosage form, lot number (or control
number or batch number), reason for the return, quantity returned, date of
disposition, and ultimate disposition of the returned drug product. If the reason
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for a drug product being returned implicates associated batches, an appropriate
investigation shall be conducted in accordance with the requirements of
211.192. Procedures for the holding, testing, and reprocessing of returned drug
products shall be in writing and shall be followed.
International GMPs
Chapter 3 Premises and Equipment
Storage Areas
3.18. Storage areas should be of sufficient capacity to allow orderly storage of
the various categories of materials and products: starting and packaging
materials, intermediate, bulk and finished products, products in quarantine,
released, rejected, returned or recalled.
Chapter 5 Production
5.65. Products returned from the market and which have left the control of the
manufacturer should be destroyed unless without doubt their quality is
satisfactory; they may be considered for re-sale, re-labeling or recovery with a
subsequent batch only after they have been critically assessed by the Quality
Control Department in accordance with a written procedure.
The nature of the product, any special storage conditions it requires, its
condition and history, and the time elapsed since it was issued should all be
taken into account in this assessment. Where any doubt arises over the quality
of the product, it should not be considered suitable for re-issue or re-use,
although basic chemical reprocessing to recover active ingredients may be
possible. Any action taken should be appropriately recorded.
Overview: Customer returns
Customers may return stock because it is oversupplied or incorrectly delivered.
However, it is not safe to assume that stock could be suitable for re-sale. There
is generally no way to tell whether the return has been tampered with, degraded
in transport or storage, or has been damaged in transit.
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GMP rules require that all returns be examined by the Quality Department and
if necessary re-tested, before they can be placed back into stock. In some cases,
if there is no way to tell if returned products have degraded, they must be
destroyed.
Products earmarked to be reissued must be kept separate from the rest of the
stock until they are investigated. They may be returned to stock, only if the
goods:
are in their original containers, unopened, and in good condition
are known to have been handled and stored correctly
have an acceptable shelf-life remaining
have been assessed by the appropriate, authorized personnel
Records must be kept of these returns, and if they are returned to stock, FIFO
must continue to be observed. Medicines that are unfit for sale must be stored
separately, and disposed of in a secure method (e.g. incineration).
GOOD TO KNOW - ASSESSING CUSTOMER RETURNS
The assessment of customer returns should take into account the nature of
the goods, and any special storage conditions they may require. If necessary,
advice should be sought from the person responsible for the quality assurance
of the manufactured product.
Considerations for handling the return of non-defective stock include:
Place a limit on the return period (e.g., 3-5 days from customer receipt).
No returns of "fridge lines".
Communicate the company's policy to customers,
Use a clear returns document that requires customers to include the
product's batch number and expiry date.
Have detailed procedures on how to handle, locate and identify returns.
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Ensure warehouse staff are trained to the returns procedure and how to
separate each return.
Ensure the returns procedure includes a detailed physical inspection, and
if necessary, a laboratory test to verify that the goods are "safe" to re-issue.
Maintain a product returns register showing dates, batch numbers,
amounts and condition of the return. This register is needed for later
investigation if there is a problem.
Managing recalls
It's almost inevitable that a company will experience a recall at some point. GMP
rules require that the warehouse (and the company) is prepared by having a
tested or validated recall procedure, which details how defective stock is
returned, registered, counted, securely separated, and securely destroyed.
GOOD TO KNOW – MANAGING RECALLS
Recalls must be very carefully managed by manufacturers in order to protect
patients and end-users. Risks surrounding recalls include:
the right people not being notified
the recalls not dealt with in a timely manner
recalled product re-entering the supply chain
The last point shows the pivotal role the warehouse plays during a recall
situation,
Warehouses should have a separate area for recalled stock where recalls from
customers are sent to the manufacturer.
Critical to a successful recall is complete and up-to-date documentation
showing where each and every part of the recalled product can be located,
either within the distribution chain or with customers.
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Step 1: Defective product in the market
In the event of a recall, QA will agree with the regulators on the scope of the
recall before the recall is triggered. The recall decision will usually happen very
quickly, so the warehouse must be recall-ready at all times. The company should
assess the quantity of stock in the marketplace at this time, with the aim of
recovering 100% of available stock.
Step 2: Recall notice Issued
The recall notice will state that the recall must occur at a particular level in the
marketplace. Class I recalls occur at the consumer level; Class II or III recalls
may occur at the retail or warehouse level. For consumer level recalls, there is
usually a company hotline to assist customers.
Step 3: Return to company locations
Defective product will be collected at nominated warehouses. It is progressively
checked, counted, and the returns recorded in a recall register. As the recall
progresses, the percentage of defective stock is monitored. The recall is
continued until 100% is returned, if possible.
Step 4: Move to dedicated Recall store
The detective product is eventually gathered in one central location in a separate,
secure Recall store or location. The recalled material must never end up in the
main warehouse.
Step 5: Destruction
Once the recalled product has been secured, it should be securely destroyed so
that there is no possibility it ends up back in the marketplace. Companies should
have secure destruction procedures, and the physical destruction should be
witnessed or otherwise verified.
Counterfeit products
Unfortunately, it has become prevalent for counterfeit medicines to make their
way into the distribution chain. Many of these products look almost identical to
the original products, both in drug appearance and packaging, These counterfeit
products contain no active ingredients (APIs), and can be dangerous to patient
health if consumed. They may even contain poisons.
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GOOD TO KNOW - BEING ALERT TO COUNTERFEIT PRODUCTS
Staff handling medicines in distribution or remote warehouse storage should
be very alert for any product that looks suspicious or different to the usual
product. If anything seems odd, it should be immediately reported to
supervision and placed in quarantine.
GOOD TO KNOW - RECALLS OF COUNTERFEITS IN THE UK
There have been 10 recalls between 2004 and 2007 where counterfeits had
reached patient level.
The MHRA counterfeiting strategy involves:
The operation of a targeted medicines surveillance scheme...to spot check
medicines on the UK market and then undertake laboratory analysis to test
for authentication.
Increased checks by MHRA inspectors for counterfeits when inspecting
pharmaceutical manufacturers and distributors.
Collaborative international enforcement action and a training and
education / awareness raising program amongst law enforcement agencies
and pharmaceutical stakeholders.
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A mix-up of sodium chloride and potassium chloride may be undetected by the
laboratory, but could have fatal consequences for patients injected with the
wrong salt.
GMP rules require that there is extensive record keeping on the receipt, testing,
storage, issue, and use of starting materials for this very reason. Without
accurate and detailed records in the warehouse, it may not be possible to
investigate a problem quickly or thoroughly. Any delay may cause additional
problems for patients. Certainly in the case of a recall the size of the recall will
be determined by the accuracy and completeness of the warehouse records.
What do the GMP rules say?
US FDA CFR211
Subpart J-Records and Reports
Sec. 211.188 Batch production and control records.
Batch production and control records shall be prepared for each batch of drug
product produced and shall include complete information relating to the
production and control of each batch. These records shall include:
(a) An accurate reproduction of the appropriate master production or control
record, checked for accuracy, dated, and signed;
(b) Documentation that each significant step in the manufacture, processing,
packing, or holding of the batch was accomplished, including:
(1) Dates
(3) Specific identification of each batch of component or in-process material used.
Subpart J-Records and Reports
Sec. 211.196 Distribution records.
Distribution records shall contain the name and strength of the product and
description of the dosage form, name and address of the consignee, date and
quantity shipped, and lot or control number of the drug product.
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International GMPs
Procedures and records
4.19, There should be written procedures and records for the receipt of each
delivery of each starting and primary and printed packaging material.
4.20. The records of the receipts should include:
a) the name of the material on the delivery note and the containers;
b) the "in-house" name and/or code of material (if different from a);
c) date of receipt;
d) supplier's name and, if possible, manufacturer's name;
e) manufacturer's batch or reference number;
f) total quantity, and number of containers received;
g) the batch number assigned after receipt;
h) any relevant comment (e.g. state of the containers).
Chapter 8
Complaints and Product Recall
8.13, The distribution records should be readily available to the person(s)
responsible for recalls, and should contain sufficient information on wholesalers
and directly supplied customers (with addresses, phone and/or fax numbers
inside and outside working hours, batches and amounts delivered), including
those for exported products and medical samples.
Overview
GMP rules require that companies have starting materials and finished product
traceability all along the supply chain. This is achieved by accurate recording in
official records and registers, the movement of all materials and products at all
stages of the product cycle.
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"Forward" traceability is needed in case the supplier discovers a defective starting
material that may harm patients. "Backward" traceability is needed in case a
patient or healthcare professional reports an adverse event or defective product.
Only by having a complete chain of toward and backward traceability can
patients' health be protected.
Inward goods
Starting materials are purchased only from approved suppliers and to authorized
specifications.
Each separate material is given a Unique Identifying Number (UIN) from the
Goods Received Register.
The UIN and the standard name are used throughout manufacturing to identify
that material and to trace its history from supplier to customer.
Goods Received Register
Standard Names List
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Status labels
SOPs and Work Instructions
INWARDS GOODS
A register should be established showing the receipt
of starting materials. The register should include:
Date of receipt
The standard name of material
The supplier's and the manufacturer's name for
the material (if different)
Manufacturer's batch or reference number
Total quantity and number of containers
received
The UIN assigned after receipt
A Standard Names List, as a minimum, contains:
the approved supplier name for the chemical
the approved manufacturer name
the company item code
the company standard name that is used on the
Bill of Materials
the grade of the material e.g. USP, BP, EP
reference to any Material Safety Data Sheets
(MSDS) or safe-handling requirements
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A list showing the standard name for each starting
material should be established.
Standard names should be specific and be designed
to minimize mix-ups.
The standard names specified on this list should be
used to label and identify starting materials during
storage and manufacture.
The standards names should be consistent with the
master batch formula.
The status of any material should be evident from
the visual appearance of its status label.
Status labels are required for all materials and
products, including intermediates.
"Reject" labels should be used only for materials
that are unfit for use. Those of uncertain status or
destined for recovery, re-processing and the like
should be designated "Hold" or "Quarantine".
SOP for inventory can come from a few sources:
External customers, such as suppliers or
distributors, may submit a PO.
The warehouse management system may
generate a PO for materials when supply is low.
If this system is linked to an MRP or production
planning system, the warehouse management
system could create POs from suppliers.
Depending on the company setup, internal
company departments, such as the QC, the
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laboratory, a production, could "purchase" raw
materials from warehouse.
Warehouse staff routinely deal with POs when
receiving starting materials or dispatching finished
product. Matching the PO to the physical goods is
an important additional check to ensure that errors
are not made in receipt or dispatch.
Self-inspections
GMP self-inspections (or internal audits) are required by the regulators, are
managed by QA, and involve all manufacturing areas, including the warehouse.
During a QA audit of the warehouse, many things will be examined, including
housekeeping, location and labeling of stock, records, warehouse training, and
monitoring of environmental controls. In particular, receipt and dispatch
registers relating to stock movement are usually examined. QA will also often
check whether there is any expired stock remaining in the Released store, and
will compare this to the company computer records.
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Summary
This module highlighted the importance of the warehouse in the day-to-day
activities of the pharmaceutical manufacturer. The warehouse plays a crucial
role in the manufacture of quality products.
Warehouse staff must abide by GMP rues to prevent goods from being
contaminated, mixed up, or degraded, and issuing the right material:
Maintaining proper housekeeping, and storing the right goods in the right
locations.
Protecting goods from pests and maintaining appropriate air and temperature
controls for the goods.
Only issuing materials to manufacture that have been approved by QC.
Adhering to FIFO principles in issue to manufacture and dispatch to
customer.
Having procedures for managing recalls.
Maintaining accurate documentation.
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