gmp a quality assurance msrppt
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GMP & Quality
Assurance
B
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Introduction GMP ensures that quality is built into the
organization & processes involved in
manufacture GMP covers all aspects of manufacture
including collection, transportation,processing, storage, QC & delivery of the
finished product
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GMP Part of QA whichensures that productsare consistently
produced & controlledto the qualitystandards appropriateto their use.
GMP is an integral partof QA.
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QA, GMP & QC inter-
relationshipQA
It is the sum total of the
organized arrangementswith the objective of
ensuring that products willbe of the quality required
for their intended use
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QC & QA Part of GMP which isconcerned withsampling,
specifications,testing and with in theorganization,documentation andrelease procedures
which ensure that thenecessary & relevanttests are carried out
QA is the sum total oforganizedarrangements made
with the object ofensuring that productwill be of the Qualityrequired by theirintended use.
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QC & QA Operationallaboratorytechniques &activities used tofulfill therequirement of
Quality
All those plannedor systematicactions necessaryto provideadequateconfidence that a
product will satisfythe requirementsfor quality
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QC & QA
QC is laboratorybased
QA is companybased
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GMP Good Manufacturing Practice Good Management Practice
Get More Profit Give more Production
GMP Training with out tears
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Ten Principles of GMP
1. Design & construct the facilities & equipmentsproperly2. Follow written procedures & Instructions3. Document work4. Validate work5. Monitor facilities & equipment6. Write step by step operating procedures & work on
instructions7. Design, develop & demonstrate job competence
8. Protect against contamination9. Control components & product related processes10. Conduct planned & periodic audits
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Beyond GMP
Reduce pollution -Zero discharge
Adaptation of environment friendlymethods
Consideration for better & healthier lifetomorrow
Consideration of ethics in life
One should begin with end in mindotherwise it will be the beginning of theend
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List of important documents in
GMP Policies SOP Specifications MFR (Master Formula Record) BMR Manuals Master plans/ files Validation protocols Forms & Formats Records
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How do GMPs of different
countries compare?
At a high level, GMPs of various nations are very
similar; most require things like: Equipment & facilities being properly
designed, maintained, & cleaned
SOPs be written & approved
An independent Quality unit (like QC and/or QA) Well trained personnel & management
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Basic Requirements of
GMP
All manufacturing processes are clearly defined,
systematically reviewed, & shown to be capable ofconsistently manufacturing medicinal products ofthe required quality & complying withspecifications.
Critical steps of the process and significant
changes to the process are validated
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Why GMP is important A poor quality medicine may containtoxic substances that have beenunintentionally added.
A medicine that contains little or noneof the claimed ingredient will not have
the intended therapeutic effect.
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QUALITY
RELATIONSHIPQuality Management
Quality Assurance
G.M.P.
Quality Control
QC
GMP
QA
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BASIC PRINCIPLE OF
QUALITY MANAGEMENT (1)
Manufacturer should ensure the cosmeticproducts comply with the requirements ofASEAN Cosmetic Directives (ACD).
They should also comply with any otherapplicable regulations pertaining to yourspecific country.
The attainment of this quality objectiveshould be led by the senior management &requires the participation and commitmentby staff, by the companys suppliers anddistributors.
http://images.google.com.sg/imgres?imgurl=http://upload.wikimedia.org/wikipedia/id/d/d6/ASEAN.gif&imgrefurl=http://id.wikipedia.org/wiki/ASEAN&h=150&w=150&sz=6&tbnid=YE-v_J-dojoJ:&tbnh=90&tbnw=90&hl=en&start=5&prev=/images%3Fq%3D%2522ASEAN%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DNhttp://images.google.com.sg/imgres?imgurl=http://upload.wikimedia.org/wikipedia/id/d/d6/ASEAN.gif&imgrefurl=http://id.wikipedia.org/wiki/ASEAN&h=150&w=150&sz=6&tbnid=YE-v_J-dojoJ:&tbnh=90&tbnw=90&hl=en&start=5&prev=/images%3Fq%3D%2522ASEAN%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DN -
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BASIC PRINCIPLE OF
QUALITY MANAGEMENT (2)
To achieve the reliable quality objective, thereshould be a comprehensive QA system
incorporating GMP.
The QA system should be fullydocumented& its effectiveness
should be monitored.
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Principles of Quality
Assurance (QA)
Wide-ranging conceptCovers all matters that individually or
collectively influence the quality of a product
Totality of the arrangementsTo ensure that the drug is of the right qualityfor the intended use
QA incorporates GMP and also product design &
development which is outside thescope of this module
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BASIC REQUIREMENTS OFQA
Ensure that products are designed and developed based onsound scientific rationale and with GMP or GLP principlesbeing taken into consideration.
Ensure that managerial responsibilities are clearly specified. Ensure that production and control operations are clearly
specified and GMP is adopted. Organize supply & use of correct starting & packaging
materials. Ensure that finished products are correctly processed &
checked before release.
Ensure that products are released after review by authorizedperson.
Provide satisfactory arrangement to ensure products arestored, distributed & handled appropriately.
Put in place a mechanism for regular self inspection / internalquality audit.
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GOOD MANUFACURINGPRACTICES
Part of QA which ensures that products areconsistently produced and controlledto the qualitystandards appropriate to their intended use.
Minimize risks :
cross contamination mix up Ensure products/materials are traceable to the
original source. Product testing is not reliable way to assure product
quality. Should BUILD quality into the product! Production and quality control functions should be
independent of each other. All manufacturing process are clearly defined and
systematically reviewed.
http://images.google.com.sg/imgres?imgurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/graphics/verb/mixup2.jpg&imgrefurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/voc/voc26.html&h=308&w=266&sz=27&tbnid=n5wIqiON5wQJ:&tbnh=112&tbnw=96&hl=en&start=19&prev=/images%3Fq%3D%2522mix%2Bup%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DGhttp://images.google.com.sg/imgres?imgurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/graphics/verb/mixup2.jpg&imgrefurl=http://www.kansaigaidai.ac.jp/teachers/shinallj/phrasalverbs/voc/voc26.html&h=308&w=266&sz=27&tbnid=n5wIqiON5wQJ:&tbnh=112&tbnw=96&hl=en&start=19&prev=/images%3Fq%3D%2522mix%2Bup%2522%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DG -
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All necessary facilities/resources for
GMP should be provided :adequate, qualified and well-trainedpersonnelsuitable premises and sufficient space
suitable locationgood personal hygiene and propersanitationsuitable equipment and services
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QUALITY CONTROL
QC is part of GMP.
QC is concerned with sampling, specification and testing.
Manufacturer should have a QC department.
QC should be headed by an appropriately qualified and
experienced person.QC should be independent from production and otherdepartments.
Ensure that the necessary and relevant tests are actuallycarried out.
Ensure that no materials or products will be released forsale or supply, until their quality have been evaluated andjudged to be satisfactory.
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SCOPE OF QC
Items concerned :Starting materials
Packaging materialsBulk productsIntermediate and finished products
Environmental conditions
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BASIC REQUIREMENTS OFQUALITY CONTROL (1)
Adequate facilities, trained personnel and approvedprocedures should be available for sampling,inspecting and testing and, where appropriate,environment monitoring.
Sampling by QC personnel & testing by approvedmethods.
Approved test methods.
Maintenance of QC records &failure investigation records.
http://images.google.com.sg/imgres?imgurl=http://www.tso.co.uk/tso_files/pharmacopoeia1.jpg&imgrefurl=http://www.tso.co.uk/key_products.html&h=213&w=170&sz=4&tbnid=U1QT7t5JIccJ:&tbnh=101&tbnw=80&hl=en&start=4&prev=/images%3Fq%3D%2522British%2Bpharmacopoeia%2522%26svnum%3D10%26hl%3Den%26lr%3D -
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BASIC REQUIREMENTS OF
QUALITY CONTROL (2)
Ingredients comply with regulatory specification (grade,composition, strength)
Review and evaluation of production documentation
Assessment of process deviations
Release of batches by authorised person
Sufficient reference samples of starting materials andfinished products
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OTHER DUTIES OF QC
Establish QC procedures
Manage reference standards
Ensure correct labelingStability testing (if applicable)
Complaint investigation
Environmental monitoring
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QUALITY CONTROLACTIVITIES
QC should cover the following:a. Samplingb. Specificationc. Testing
d. Release procedurese. Recalls and complaintsf. Decision making in all quality mattersg. Definition of product qualityh. Laboratory operationsi. Release authorisationj. Investigation and reporting
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BASIC REQUIREMENTS OFQUALITY CONTROL
Adequate facilities, trained personnel and approvedprocedures should be available for sampling, inspectingand testing and, where appropriate, environmentmonitoring.
Sampling by QC personnel & testing by approvedmethods. Approved test methods. Maintenance of QC records & failure investigation
records. Ingredients comply with regulatory specification
(grade, composition, strength) Review and evaluation of production documentation Assessment of process deviations Release of batches by authorised person Sufficient reference samples of starting materials and
finished products
http://images.google.com.sg/imgres?imgurl=http://www.tso.co.uk/tso_files/pharmacopoeia1.jpg&imgrefurl=http://www.tso.co.uk/key_products.html&h=213&w=170&sz=4&tbnid=U1QT7t5JIccJ:&tbnh=101&tbnw=80&hl=en&start=4&prev=/images%3Fq%3D%2522British%2Bpharmacopoeia%2522%26svnum%3D10%26hl%3Den%26lr%3D -
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OTHER DUTIES OF QC
Establish QC procedures
Manage reference standards
Ensure correct labelingStability testing (if applicable)
Complaint investigation
Environmental monitoring
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PERSONNEL
Adequate staff with relevant knowledge,experience and capabilities in assigned taska. Production and QC are headed bydifferent persons, neither of whom shallbe responsible to the otherb. Responsibilities and authority of key
personnel are clearly definedc. Training on the understanding ofprocedures, work instruction, GMPprinciples , etc.
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Personnel Qualifications Each person engaged in the manufacture,
processing, packing, or holding of a drug
product shall have education, training, andexperience, or any combination thereof, toenable that person to perform theassigned functions. Training shall be ...
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There are competent and appropriately qualifiedpersonnel in sufficient numbers to ensure serviceprovision. The responsibilities of all staff should be
clearly understood and recorded. All personnel receive initial and continuing
training relevant to their needs.
Only staff who have appropriate training areauthorisedto carry out that procedure. Training should be structured and continuous.
Training records based on SOPs are a goodmeans of evidencing that staff are able toperform tasks.
Competency Assessments can also be usedto assess procedural training.
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3 Key Personnel The head of production The head of QC
The head of QM (QA)
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The head of production
The head of production should be aqualified pharmacist, adequately trained,possess good practical experience in
pharmaceutical manufacture & managerialskill. The head of production should have full
authority & responsibility to manage
production of pharmaceutical products.
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The head of QM (QA)
The head of QM (QA) should be aqualified pharmacist, have adequatetraining & practical experiences which
enable him/her to perform him/herfunction personally.
The head of QM (QA) should given full
authority & responsibility in all qualitysystem/assurance duties.
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PREMISES
Specify the requirements of location, design ,constructions and maintenance of manufacturingpremises with respect to the following:
a. prevention of contamination from surrounding
environment and pestsb. prevention of mix up of materials and products
c. facilities such as toilet, changing rooms, samplingareas and QC lab
d. defined areas for certain activitiese. wall, ceiling, drains , air intake and exhaust,
lighting and ventilation, pipe work and lightfitting
f. storage areas
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Suitable location, design , constructions andmaintenance for manufacturing premises :
defined areas for certain activities (e.gmaterial sampling & dispensing)
wall, ceiling, drains , air intake and
exhaust, lighting and ventilation, pipe workand light fitting
storage areas of adequate space
Physical separation of toilets and QC labfrom production
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Building & facilities1. Design and construction features.2. Lighting.3. Ventilation, air filtration, air heating and
cooling.4. Plumbing.5. Sewage and refuse.6. Washing and toilet facilities.
7. Sanitation.8. Maintenance.
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Paint Finish Not only building
paintwork must be
considered but alsoequipment
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Building Finishes:
In module 1 we discussed the need for allfacility components to complement eachother.
Therefore a good air handling systemmust be complemented by a building ofgood design and good finishes.
On the next slide we will be looking atsome of the Acceptable and Un-acceptable
building finishes.
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Building Finishes
Not Acceptable AcceptablePVA Paint L Epoxy or Enamel paint J
Window sills L Flush glazed windows J
Exposed pipes L Smooth surfaces J
Horizontal pipes & services L Concealed services J
Open floor drains L Hygienic drains J
Floor cracks, flaking floorsurfaces
LHomogonous sealed floors epoxy finish or welded vinyl J
Ceiling cracks & joints L Smooth sealed ceilings J
Exposed, open light fittings L Flush light fittings J
Wooden furniture LS/Steel or Melaminefurniture J
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Design and ConstructionFeatures
Any building or buildingsused in the manufacture,processing, packing, or
holding of a drug productshall be of suitable size,construction, and locationto facilitate cleaning,maintenance, and properoperation.
http://images.google.com.sg/imgres?imgurl=http://www.thechaocenter.com/Warehouse.jpg&imgrefurl=http://www.thechaocenter.com/news.html&h=768&w=1024&sz=46&tbnid=kqyp0PPQDO0J:&tbnh=112&tbnw=150&hl=en&start=41&prev=/images%3Fq%3D%2522warehouse%2522%26start%3D40%26svnum%3D10%26hl%3Den%26lr%3D%26sa%3DN -
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Product Areas
Premises should preferablybe laid out in such a way as: To allow the production to take
place in areas connected in a
logical order corresponding tothe sequence of the operations,the requisite cleanliness levels,
To avoid crowding and disorder,
To allow effectivecommunication and supervision.
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Weighing Area The weighing of starting materials and the
estimation of yield by weighing should be
carried out in separate weighing areasspecially designed for that use. Such areasmay be part of either storage orproduction areas.
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Storage Areas
Specify the requirements concerning storage ofmaterials/ products with respect to thefollowing
a. Space, design, security and cleanlinessb. Storage of quarantine stocksc. Storage of hazardous substancesd. Conditions of storage area
e. (e.g. temperature & relative humidity)f. Receiving of incoming materialsg. Stock control (e.g. FIFO principle,h. proper labeling on the container)
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Ventilation, Air Filtration, Air
Heating and CoolingEquipment for adequate control over air
pressure, micro-organisms, dust, humidity,and temperature shall be provided when
appropriate for the manufacture,processing, packing, or holding of a drugproduct.
Air-handling systems for ... penicillin shallbe completely separate from those forother drug products for human use.
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QC Areas
QC laboratories should bedesigned to suit the operationsto be carried out in them.
QC laboratories should be
separated from productionareas. Areas where biological or
radioisotope test methods are
employed should be separatedfrom each other.
ll
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Ancillary Areas
Rest and refreshment rooms should beseparated from production & QClaboratory areas.
Facilities for changing clothes and forwashing and toilet purposes should beeasily accessible & appropriate for the
number of users.
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Thank youfor
Your Kind
Attention