sample quality manual for laboratories

www.pharmacygraduates.org

Quality Systems Policy Manual

Sample Quality policy manual for Laboratories Aravindsai Nagubandi www.pharmacygraduates.org [email protected]

This document contains the policies and reference procedures followed the laboratory to

ensure that the study is conducted in accordance with OECD GLP guidelines

http://www.pharmacygraduates.org/


Contents

..........................................................................................................................................................1

1. Terms and definitions ..................................................................................................................3

2. Procedures referenced in the Manual ............................................................................................4

3. Quality policy .............................................................................................................................4

4. Roles and responsibilities.............................................................................................................5

5. Facility .......................................................................................................................................6

6. Apparatus, materials and reagents.................................................................................................6

7. Test systems................................................................................................................................7

8. Test and reference items ..............................................................................................................7

9. Standard operating procedures......................................................................................................7

10. Performance of study ...............................................................................................................8

11. Reporting of study results .........................................................................................................9

12. Storage and retention of Records and materials ..........................................................................9

SOP OO8: Handling of test system individuals found moribund or dead during the study. ..................... 10


1. Terms and definitions (OECD Principles of Good Laboratory Practice)

Term Definition

Test facility Persons, premises and operational unit(s) that is necessary for Conducting the non-clinical health and environmental safety study.

For multi-site studies, those which are conducted at more than one site, the test facility comprises the site at which the Study Director

is located and all individual test sites, which individually or collectively can be considered to be test facilities

Test site Means the location(s) at which a phase(s) of a study is conducted.

Test facility

management

person(s) who has the authority and formal

Responsibility for the organization and functioning of the test facility according to these Principles of Good Laboratory Practice.

Sponsor Entity which commissions, supports and/or submits a non-clinical health and environmental safety study

Study Director Individual responsible for the overall conduct of the nonclinical health and environmental safety study

Standard

Operating

Procedures

Documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.

Master schedule Compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.

Raw data all original test facility records and documentation, or verified

copies thereof, which are the result of the original observations and activities in a study. Raw data also may include, for example,

photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been

recognized as capable of providing secure storage of information for a time .


2. Procedures referenced in the Manual

Procedures (OECD Principles of Good

Laboratory Practice)

Referred as

Receipt, identification, labeling, handling, sampling and storage of test and reference

items.

SOP 001

Use, maintenance, cleaning and calibration of apparatus.

SOP 002

Labeling for materials, reagents and solutions. SOP 004

Coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerized systems.

SOP 005

Room preparation and environmental room conditions for the test system.

SOP 006

Procedures for receipt, transfer, proper

placement, characterization, identification and care of the test system.

SOP 007

Handling of test system individuals found

moribund or dead during the study.

SOP 008

Test system preparation, observations and examinations, before, during and at the conclusion of the study.

SOP 009

Collection, identification and handling of

specimens including necropsy and histopathology

SOP 010

Siting and placement of test systems in test

plots.

SOP 011

Operation of Quality Assurance personnel in planning, scheduling, performing,

documenting and reporting inspections

SOP 012

3. Quality policy

3.1. The test facility is committed to assure that the studies being performed under this

laboratory are in compliance with OECD principles of Good laboratory practices.


Procedures are developed to achieve this, all the deviations from the procedures are

investigated and corrected.

4. Roles and responsibilities

ROLE RESPONSIBILITIES

Lab Manager.

Ensures compliance with the Principles of Good Laboratory

Practice within the test facility.

Maintains sufficient number of qualified personnel.

Maintains documents and Masters Schedule/ ensures proper documentation is maintained.

Arranges trainings for personnel and maintains training evaluation records.

Manages archiving records/ appoints an individual to manage archiving records.

Study Director Overall conduct of the study and final report.

Approves the study plan and its amendments

Maintains effective communication with Quality assurance personnel and assures that they have

Inform/ train the personnel with the changes in the study plan and procedures.

Ensure that data integrity is maintained between raw data and reports.

Ensure Validation and calibration of required equipment’s and computer systems.

Quality

assurance

manager

Ensure that the study is conducted in accordance with the

applicable Principles of Good Laboratory Practice.

Maintain copies of all approved study plans and Standard

Operating Procedures and up to date master schedule.

Conduct study, facility and process inspections to verify the

study is being conducted on GLP principles and maintain the records of inspection.

Chemists Comply with the instructions given in standard operating procedures and study plan.

Communicate deviations from the procedures with the study director


5. Facility

5.1.The test facility is of suitable size, construction and location to meeting requirements

of the study and to minimize disturbance that would interfere with the validity of the study.

5.2.University is committed to provide if any additional requirements, if needed in the

future, There are a number of empty rooms that would be suitable for the housing of other small animals.

5.3.The university has an animal house in a facility, with its own Manager, three animal

technicians, and a consulting Veterinarian. The only species of animals housed there

at the moment are rats. 5.4.There are separate partitions in the laboratory which provide areas for receipt and

storage of the test and reference items, and mixing of the test items with a vehicle. These areas are adequate to adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.

5.5.There is an archival facility is maintained by the University's Engineering Department who are responsible for security and for the maintenance.

(Importance and consequences: If the areas are not partitioned, receipt materials may get mixed with storage products, which may end up with giving wrong test

article to the test system producing a false data. If the archival facility is not secured data may be lost or stolen, study needs to be

done again to get the data, which is a waste of time and money)

6. Apparatus, materials and reagents

6.1.Apparatus are located in appropriate design. And their installion is qualified.

6.2.All the equipment’s used in the facility carry a status label which indicates the status of calibration, cleaning status (ref: SOP 002).

6.3.Equipment’s effect on the test systems is evaluated with the help of consulting Veterinarian; equipment’s are used only if they are safe to be used.

6.4.Only labeled reagents are permitted for use in the facility (label contains: Identity

expiry date and specific storage instructions, Information concerning source, preparation date and stability)

(Importance and consequences: If the apparatus doesn’t work as installed or the design of room doesn’t suit the equipment functioning, the results obtained from the

equipment will no longer be accurate, which means that the research is not credible Even if the equipment functions properly, and if affects the safety

of the animal, due to the biochemical changes (induced by apparatus but not test article) interferes with the study leading to a wrong data. Labeling is to ensure that right things are given to right test

systems)


7. Test systems

7.1.All rats used in laboratory come from the approved supplier, Supplier qualification is

performed by Quality assurance with the requirements addressing study director and consulting veterinarian.

7.2.When the animals are received their source, date of arrival, and arrival conditions are

recorded and the documents are maintained by the QA department.(ref: SOP 007) 7.3.Newly received animal and plant test systems will be isolated until their health status

has been evaluated by the consulting Veterinarian. A label indicating their status will be placed on their cage.

7.4.Cleaning and maintenance of animals is done by the three animal technicians at the

animal house facility and these are monitored by animal house facility manager. 7.5.Pesticides used in the animal house are evaluated by veterinarian (for interference

with animal safety) and study director (for inference in the study).(ref: SOP 006). 7.6.If the animals or infected, dead or diseased the information will be recorded

immediately and animals are isolated/ disposed so that they doesn’t affect other

animals or quality of the study. (ref: SOP 008 and SOP 010)

(Importance and consequences: If the test systems are used even before their health status is not evaluated and if the animal dies due to its health conditions, things cannot be achieved on time.

Health conditions and properly monitored and all the factors which affects the health of test systems should be monitored so as to decrease the interference with the

research / test article.)

8. Test and reference items

8.1.When the test items are received they will be inspected by the study personnel for the label containing their identity (Chemical Abstracts Service Registry Number [CAS

number], name, and biological parameters), expiry date, and quantity and storage conditions (Ref: SOP 001). They will place in quarantine area till the inspection and

approval. 8.2.After the approval they will be placed in the storage area based on their label

instructions (ref: SOP 004).

8.3.Sample retention area is provided in the laboratory where the samples of each batch

are stored.

(Importance and consequences: Inspection and approval is to ensure that right test

article is being given to the test system. If a different product is given then it will lead

to a different research, this can lead to waste of time and money)

9. Standard operating procedures

9.1.List of SOP’s

Receipt, identification, labeling, handling, sampling and storage of test and

reference items.


Use, maintenance, cleaning and calibration of apparatus.

Validation, operation, maintenance, security, change control and back-up of

computerized systems.

Labeling for materials, reagents and solutions.

Coding of studies, data collection, preparation of reports, indexing systems,

handling of data, including the use of computerized systems.

Room preparation and environmental room conditions for the test system.

Procedures for receipt, transfer, proper placement, characterization,

identification and care of the test system.

Test system preparation, observations and examinations, before, during and at

the conclusion of the study.

Handling of test system individuals found moribund or dead during the study.

Collection, identification and handling of specimens including necropsy and

histopathology

Siting and placement of test systems in test plots.

Operation of Quality Assurance personnel in planning, scheduling,

performing, documenting and reporting inspections

9.2.All the standard operating procedures and their revisions are approved by test facility

management.

9.3.Only the current versions are made available to personnel and the old versions are

archived.

(Importance and consequences: Standard operating procedures are to ensure that

the policies are being carried out as required. If there are no procedures available

then there is no assurance that the policies are followed)

10. Performance of study

10.1. Study plan approved by study director is checked for GLP compliance by the QA

before initiation of the study (ref: SOP 012).

10.2. All the amendments made are approved by the study director, indicating the

justification of amendment.

10.3. Any deviations from the study plan while conduct of the study is reported to study

director who will be assessing the risk and management.

(Importance and consequences: Study plan is to assure that things are not being

retrospectively done, if the things are retrospective then the data will not be

considered as credible)


11. Reporting of study results

11.1. Final reports are signed by the study director carrying the acceptance of

responsibility of validity of data.

11.2. Any corrections or changes are made in the form of amendments indicating their

reason.

(Importance and consequences: Signatures in the final report indicate the study

director assurance of the results obtained, if he doesn’t assure the study, then the study is not considered as credible)

12. Storage and retention of Records and materials

12.1. All the versions of standard operating procedures except the current versions,

historical test results, environment monitoring records, validation and maintenance

documents are indexed for easy retrieval and archived (ref: SOP 005).

12.2. Archival room is secured 24 hours and only the authorized personnel have assess,

inspectors or visitors who are approved for entry should be escorted all time during

their visit by the authorized personnel.

(Importance and consequences: Archived records should be easily retrieved, or else

it would take a lot of time to search for documents, during the inspections if the right

documents cannot be provided in right time auditors might feel that the things are not

organized)


SOP OO8: Handling of test system individuals found moribund or dead during the study.

Division of pharmaceutical product development

SAI UNIVERISTY

Purpose and Scope: This is procedure to handle dead and moribund animals during the study and this procedure applies to animal house facility manager and technical staff. Responsibility: Technical staff of animal house facility.

Date issued: 09/10/2010 Date revised: 29/10/2010

Procedures:

1. All the animals are monitored addressing the SOP 007 entitled Procedures for receipt,

transfer, proper placement, characterization, identification and care of the test system.

2. If any animals are found moribund or dead, the technical staff should look at the contact

information sheet and inform the respective person.

3. Staff should directly report to the facility manager, and if the facility manager

4. If the animals are found moribund facility manager or technicians should report the report

the research staff and consulting veterinarian immediately, to allow them to resolve the

problem, all these communication and actions should be recorded.

5. When the animal is found dead

Record as “found dead “in the animal’s cage card.

Place the dead animal in the plastic bag and place it in the area designated, and

report the facility manager, who is responsible to report to the research staff.

Record the number of animals found dead at the cage.

6. Deduct the number of animals from the cage sheet (original number of animals- number

of dead animals)

7. Clean and sanitize the cage.

Approved: (study director signature)

Date:

13. References:

OECD Principles of Good Laboratory Practice, 1997

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