Pqa U3.2 GLP

B.
Pharm- Third Year
Pharmaceutical Quality Assurance (PQA)
U3.2: Good Laboratory Practices

UNIT – III
Quality control of packaging material: Quality control test for containers, rubber closures
and secondary packing materials.
Good Laboratory Practices & Role of CPCSEA

U3- 3.2- Good Laboratory Practices
CONTENT
1. General requirements
2. Premises
3. Personal
4. Equipment
5. Chemicals & Reagents
6. Good House Keeping and Safety
7. Maintenance, calibration, validation of equipment
2
CONTENT
8. Reference materials
9. Quality Assurance
10. Audit
11. Management review
12. Standard Operating Procedures
13. Protocols and Specifications archive
3
GOOD LABORATORY PRACTICES
Good Laboratory practices can be defined as

“A body of rules, operating procedures and practices established by a given organization that
are considered to be mandatory with a view to ensuring quality and correctness in the results
produced by a laboratory.”
The goal is to certify that every step of the analysis is valid.
4
PRINCIPLES OF GLP
To Promote development of quality test data and provide tool to ensure a sound approach
to the management of laboratory studies, including conduct, reporting and archiving.
A set of standards for ensuring the quality, reliability and integrity of studies, the reporting
of verifiable conclusions and traceability of data.
The principles require institutions to assign roles and responsibilities to staff in order to
ensure good operational management of each study.
5
PRINCIPLES OF GLP
GLP principles apply to non-clinical studies which includes analytical aspects, safety of
items with respect to human health and/or environment.
The requirement to formulate study plan with a defined scientific purpose.
The GLP principles are independent of the site where studies are performed (Manufacturer’s
lab, contract facility or university lab)
6
PRINCIPLES OF GLP
Adherence to
GLP
False start and prevents/ removes
diminish the Many sources
incidence of of error and
incomplete or uncertainty
inconclusive
studies
7
GENERAL REQUIREMENTS
a) It is the responsibility of the management to ensure that the laboratory carry out its
testing, calibration, validation, all other technical activities in such a way as to meet
Good Laboratory Practices requirements.
a) Laboratory management shall have a qualified individual for carrying out all technical
activities and for the implementation of documented quality system and shall report to
the top management directly.
8
GENERAL REQUIREMENTS
c) The quality manager shall prepare a schedule for technical audit of the laboratory for
GLP compliance by an expert appointed by the top-management other than the in charge
of the laboratory and shall ensure the maintenance of documented quality system as per
Quality Manual.
9
2- PREMISES
(a)(i) The laboratories shall be designed, constructed and maintained so as to prevent entry
of insects and rodents
(ii) Interior surface (walls, floor and ceilings) shall be smooth and free from cracks and
permits easy cleaning and disinfection;
(iii) Adequate provision is made not only for space and equipment for carrying out necessary
test but also for utilities like water, power and gas;
(iv) Air ventilation system shall ensure dust free environment;
10
2- PREMISES
(b) Adequate space with proper storage conditions in the laboratory shall be provided for
keeping reference and working standards
(c) The air circulation is maintained in the area where sterility test is carried out as per
Schedule ‘M’
(d) Bio-burden shall be routinely maintained in the controlled and uncontrolled area. (e.g. air
locks)
(e) Animal House shall have the approval of the Committee for the Purpose of Control and
Supervision on Experiments on Animals (CPCSEA).
11
3- PERSONNEL
(a) Staff in the laboratory shall possess necessary qualification, proper training and shall
have adequate experience for the assigned duties.
(b) A training record of all the personnel shall be maintained.
(c) Head of the laboratory must be of high professional standing with experience in drug
analysis and laboratory managements who is responsible for,
(i-iv)
12
3- PERSONNEL
(i) ensuring the control and maintenance of documents including the quality system as per
the requirements of regulatory authorities which involve all raw data, SOPs, protocols,
trainings, charts, etc.
(ii) planning and organizing the audit of the quality system and initiation as well as follow
up action of the corrective actions, if any;
(iii) investigation of technical complaints;
(iv) taking final responsibilities for recommending any regulatory action in the event of
noncompliance of tested samples.
13
4- EQUIPMENT
(a)The laboratory shall have all types of equipments necessary for carrying out the different
activities within the laboratory.
(b)The analytical instruments shall be housed in dust free environment, conditions of

temperature and humidity shall be maintained and periodic checks on temperature and
humidity shall be made and recorded.
(c)The instruments, instrument bench and surrounding areas shall be kept clean and tidy at
all times.
14
4- EQUIPMENT
(d) Instruments requiring calibration shall be calibrated at regular intervals and records of
such calibration or maintenance be maintained
(e) A progress register for non-functional equipment shall be maintained.
(f) Burettes, pipettes, volumetric flasks, weight boxes, thermometers, etc., shall be
thoroughly checked for calibration before acceptance for use.
(g) Maintenance procedure SOP must be prepared and regular servicing must be performed
by the maintenance engineer or specialist
15
4- EQUIPMENT
(h) equipment records shall be maintained and such records shall contain the following.
(i) name of equipment or machine or apparatus;
(ii)manufacturer’s name , model number and type of identification;
(iii)serial number;
(iv)date on which equipment was received in laboratory;
(v)current location;
(vi) condition when received (e.g. new, used, reconditioned);
(vii) copy of the manufacturer operating instructions;
(viii) frequency of calibration;
16
4- EQUIPMENT
(ix) frequency of maintenance

(x) log book (day to day entry including status of the equipment)
(xi) staff responsible for monitoring the calibration and maintenance status of the equipment;
(xii) calibrating records
(xiii) list of authorized users or operators, if any;
(xiv) history of any damage, malfunction, modification or up-gradation, repair and
calibration;
(xv) list of spares and accessories, if any.
17
5- CHEMICALS AND REAGENTS
a) The storage and handling of chemicals and reagents shall be done considering the
physicochemical properties of these substances and the hazards involved in their use.
b) All reagents and solutions in the laboratory shall be properly identified with a label.
c) A standardization register shall be maintained by the laboratory along with its raw data
and SOP and standardization on stock solutions, standard solutions, volumetric solutions
must be prepared for the guidance to staff.
18
5- CHEMICALS AND REAGENTS
(d) Containers of stock solutions and of standard shall bear the following details-
(i) Name of the analyst who prepared solution

(ii) Date of preparation;
(iii) Each volumetric solution shall have “ use before date” depending upon the stability of
the solution; and
(iv) Standardization records
19
6- HOUSE KEEPING
SOP for safety, house-keeping and loss prevention shall be prepared and include the
following requirements, namely:-
(i) Safety data sheets must be made available to staff before testing is carried out;
(ii) Drinking, eating and smoking shall not be permitted in the laboratories;
(iii) Staff must wear laboratory coats or other protective clothing including gloves and face
masks and eye protection whenever required;
20
6- HOUSE KEEPING
(iv) the laboratories shall have adequate first aid kit and fire fighting equipment and eye
washers
(v) operators carrying out sterility tests shall wear sterilized garments including headgear,
masks and shoes;
(vi) staff must be educated in the first aid techniques, emergency care and use of antidotes;
and
(vii) safety rules in handling cylinders of compressed gases must be observed and staff must
be familiar with relevant color identification codes.
21
7- MAINTENANCE and CALIBRATION
(a) All equipment, instruments and other devices used in the laboratory shall use appropriate
methods and procedures for all tests or calibration and they shall be qualified, calibrated and
recalibrated at predetermined intervals.
(b) The original equipment manufacturer’s recommendations be considered while fixing the
frequency of calibration.
(c) SOP for calibration and calibration schedule be prepared by the laboratory and a logbook
shall also be prepared by each laboratory for proper documentation of calibration results.
22
8- REFERENCE MATERIALS
(a) Reference materials are necessary for the testing, calibration, validation or verification of
a sample or of equipment, instruments or other devices and all such materials shall be
traceable to agency authorized by Government of India or any other International body.
(b) All working standards shall be checked at appropriate intervals or before use to ensure
that it has not decomposed during storage. These observations be recorded in a register.
(c) All the reference and working standard shall be stored at appropriate storage condition;
those requiring storage between 2- 8°C shall be stored in a refrigerator.
23
8- REFERENCE MATERIALS
(d) a register pertaining to reference and working materials must be maintained by the
laboratory. The following details may be mentioned in the register:
(i) source of supply
(ii) code number of the reference material;
(iii) date of receipt;
(iv) batch number or identification number of the supplying agency;
(v) details like assay value, water content or any other information provided;
(vi) storage condition of the material; and
(vii) date of expiry, if any and date of manufacturing if possible.
24
9- QUALITY ASSURANCE
The quality system shall be designed to ensure the following objectives:-
(a) The measurements and calibrations shall fully conform to the compendial requirements
and methods demonstrably based on validation protocols are followed.
(b) It should be effective in providing necessary assurance that the activities or processes or
techniques or practices comply with planned arrangements.
25
9- QUALITY ASSURANCE
The quality system shall be designed to ensure the following objectives:-
(c) It helps in early detection and correction of non conformities.
(d) Remedial action on the observations by internal and external audits are taken
appropriately and
(e) It shall have a documented quality policy for the organisation.
26
10- AUDITS
(a) Internal audits are done periodically with a predetermined schedule and procedure with
appropriate checklist. Internal quality audits shall be carried out by trained and qualified
personnel.
(b) The periodicity of quality audit shall be fixed by head of laboratory so that each activity
to be audited at least once in a year.
(c) Head of the lab will be responsible for initiation of the corrective action arising from
audits and verification of corrective action.
27
11- MANAGEMENT REVIEW
Quality system review shall be conducted by the top management at least once in every
twelve months and agenda of review shall generally cover the following;
(i) report of internal audits;
(ii) matter arising from previous reviews
(iii) report of external audits, if any;
(iv) Complaints or feedback received from users of laboratory services;
(v) Details of in-house quality control checks;
(vi) induction training of new staff; and
(vii) any other requirements of the laboratory.
28
12- SOP
SOP’s in addition to those recommended under various activities shall also be prepared to
the minimum in respect of the following:
(1) sample handling;
(2) receipt, identification, storage, method and sampling of the test and control articles;
(3) record keeping, reporting, storage and retrieval of data;
(4) coding of different studies, handling of data including use of computerized data system;
(5) operation of technical audit personnel in performing and reporting audits, inspections and
final report reviews; 29

12- SOP
(6) routine inspection of cleaning, maintenance, testing, calibration and standardization of
instruments;
(7) action to be taken in respect of equipment failure;
(8) analytical data methods;
(9) health and safety protection (precautions)
(10) animal room preparation
(11) animal care
30
12- SOP
(12) maintenance of sterility room (i.e. constant maintenance and monitoring of Aseptic
condition of sterility room);
(13) use and storage of reference standard’s
(14) Procurement of stores and equipment; (chemical and reagents/solvents)
(15) monitoring of testing of samples
– easy to write SOP but difficult to comply
31
12- SOP
(16) document control
(17) housekeeping
(18) corrective and preventive action;
(19) working procedure (test methods);
(20) training manual.
32
13- SPECIFICATIONS
(a) Every laboratory shall have a specification archives and current version of all necessary
specifications, shall be kept as per the requirements of the Act and the rules made thereunder
and the National Pharmacopoeia (Indian Pharmacopoeia)
(b) All updates and corrections must be noted in the master volumes of Pharmacopoeias to
prevent the use of obsolete sections; supplement and addendum shall also be made available
in the laboratory.
33
13- SPECIFICATIONS
(c) The specification archive shall contain the following:-

(i) list of all pharmacopoeia's
(ii) a file on patent and proprietary medicines (non- pharmacopoeial) test methods to
specifications prepared and validated by the manufacturer or by the laboratory itself. The
validated test methods developed by the manufacturer or the laboratory shall stand to the
requirements of compendial parameters in regards to its precision, accuracy, reproducibility,
specificity, linearity, and ruggedness etc.
34
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
❑ Our regulation of the conduct of nonclinical laboratory studies is important to ensure the
quality and integrity of data derived from those studies, the protection of human
subjects, and that marketing decisions are based on accurate and reliable data.
❑ Nonclinical laboratory study means in vivo or in vitro experiments in which test articles
are studied prospectively in test systems under laboratory conditions to determine their
safety.
❑ The term does not include studies utilizing human subjects or clinical studies in animals.
35
Good Laboratory Practice for Nonclinical Laboratory Studies
Contents
1. Definition
2. History
3. General Provisions
4. Organization and personnel
5. Facilities
6. Equipment
7. Testing facilities operation
8. Test and Control Articles
9. Protocol for and Conduct of Nonclinical Study
10. Records and Reports
36

Good Laboratory Practice
Good Laboratory Practice is a quality system concerned with the organizational process
and the conditions under which a study is planned, performed, monitored, recorded, archived
and reported.
Why GLP?
Development of quality test data
Mutual acceptance of data
Avoid duplication of data
Protection of human health and the environment
37

HISTORY
Created GLP is a formal regulation that was by the FDA (United states food and drug
administration) in 1978.
Although GLP originated in the United States , it had a worldwide impact.
Non-US companies that wanted to do business with the United States or register their
pharmacies in the United States had to comply with the United States GLP regulations.
38

HISTORY
They eventually started making GLP regulations in their home countries.
In 1981 an organization named
OECD (Organization for Economic Co- operation and Development) produced GLP
principles, that are international standard.
High Quality and Reliable Test Data

39
1. Subpart A - General Provisions Scope
This part prescribes good laboratory practices for conducting non-clinical laboratory
studies that support or are intended to support applications for research or marketing permits
for products regulated by the FDA, including food and colour additives, animal food
additives, human and animal drugs, medical devices for human use, biological products.
40
1.Subpart A - General Provisions Scope
Inspection of a testing facility

A testing facility shall permit an authorized employee of the FDA, at reasonable times and
in a reasonable manner, to inspect the facility all records and specimens required to be
maintained regarding studies within the scope of this part.
If the testing facility refuses to permit inspection the Food and Drug administration will
not consider a non-clinical laboratory study in support of an application for a research or
marketing permit.
41
Sub part B - Organisation and Personnel
Each individual engaged in the conduct of or responsible for the supervision of a non-
clinical laboratory study shall have education, training, and experience
There shall be a sufficient number of personnel for the timely and proper conduct of the
study according to the protocol.
Personnel shall take necessary personal sanitation and health precautions designed to
avoid contamination of test and control articles and test systems.
42
Personnel engaged in a non-clinical laboratory study shall wear clothing appropriate for
the duties they perform.
Any individual found at any time to have an illness that may adversely affect the quality
and integrity of the non-clinical laboratory study shall be excluded from direct contact with
test systems, test and control articles
43

Testing facility management- For each non-clinical laboratory study, testing facility
management shall:
Assure that test and control articles or mixtures have been appropriately tested for identity,
strength, purity, stability, and uniformity, as applicable.
Assure that personnel, resources, facilities, equipment, materials and methodologies are
available as scheduled.
Assure that any deviations from these regulations reported by the quality assurance unit
are communicated to the study director and corrective actions are taken and documented.
44

Study director
For each non-clinical laboratory study, a scientist or other professional of appropriate

education, training, and experience, or combination thereof, shall be identified as the study
director.
The study director has overall responsibility for the technical conduct of the study, as well
as for the interpretation, analysis, documentation and reporting of the results, and represents
the single point of study control.
45
Study director
The protocol including any change, is approved and is followed.
All experimental data, including observations of unanticipated response of the test system
are accurately recorded and verified.
All applicable good laboratory practice regulations are followed
46
Quality assurance unit

Responsibilities of the quality assurance unit
Monitoring each study to assure management that the facilities, equipment, personnel,
methods, practice, records, and controls are in conformance with the regulations in this part.
For any given study, the quality assurance unit shall be entirely separate from and
independent of the personnel engaged in the direction and conduct of that study.
47

Functions of the quality assurance unit:
Maintain a copy of a master schedule sheet
Inspect each non-clinical laboratory study at intervals adequate to assure the integrity of
the study and maintain written and properly signed records of each inspection
Determine that no deviations from approved protocols or standing operating procedures
were made without proper authorization and documentation.
A designated representative of the FDA shall have access to the written procedures
established for the inspection and may request testing facility management to certify that
inspections are being implemented, performed, documented, and followed-up.
48
Subpart C – Facilities General
Each testing facility shall be of suitable size and construction to facilitate the proper
conduct of non-clinical laboratory studies. It shall be designed so that there is a degree of
separation that will prevent any further function or activity from having an adverse effect on
the study.
Animal care facilities
A testing facility shall have sufficient number of animal rooms or areas

49

Facilities for handling test and control articles
Separate areas shall be provided, as proposed, for the diagnosis, treatment, and control of
laboratory animal disease.
When animals are housed, facilities shall exist for the collection and disposal of all animal
waste and safe sanitary storage of waste before removal from the testing facility.
50

As necessary to prevent contamination or mix-ups, there shall be separate areas for

Receipt and storage of the test and control articles.
Storage areas for the test and or control article shall be separated from areas housing the
test systems and shall be adequate to preserve the identity, strength, purity, and stability of
the articles.
51
Laboratory operation areas
Separate laboratory space shall be provided, as needed, for performance of the routine and
specialised procedures required by nonclinical laboratory studies.
Space shall be provided for archives, limited access by authorized personnel only, for the
storage and retrieval of all raw data and specimens from completed studies.
52

Subpart D – Equipment
Equipment design
Equipment used in the generation, measurement, or assessment of data and equipment
used for facility environmental control shall be of appropriate design and adequate capacity
to function according to the protocol and shall be suitably located for operation, inspection,
cleaning and maintenance.
Maintenance and calibration of equipment
Equipment used for the generation, measurement, or assessment of data shall be
adequately tested, calibrated or standardized. Written records shall be maintained of all
inspection, maintenance, testing, calibration and operations.
53
Subpart E - Testing Facilities Operation

Standard operating procedures
Standard operating procedures shall be established for
Animal room preparation.
Animal care.
Receipt, identification, storage, handling, mixing, and method of sampling of the test and
control articles.
Test system observations.
Laboratory tests.
54

Standard operating procedures
Handling of animals found moribund or dead during study.
Necropsy of animals or post mortem examination of animals.
Collection and identification of specimens.
Histopathology.
Data handling, storage, and retrieval.
Maintenance and calibration of equipment.
Transfer, proper placement, and identification of animals.
55

Reagents and solutions
All reagents and solutions in the laboratory areas shall be labelled to indicate identity,
concentration, storage requirements, and expiration date. Deteriorated or outdated reagents
and solutions shall not be used.
Animal care
There shall be standard operating procedures for the housing, feeding, handling, and care
of animals.
All newly received animals from outside sources shall be isolated and their health status
shall be evaluated
56

At the initiation of a non-clinical laboratory study, animals shall be free from disease.
If, during the course of the study, the animals contract such a disease or condition, the
diseased animals shall be isolated, if necessary
These animals may be treated for disease or signs of disease provided that such treatment
does not interfere with the study.
The diagnosis, authorisation of treatment, description of treatment, and each date of
treatment shall be documented and shall be retained.
Animals of different species shall be housed in separate rooms when necessary.
57

Animal cages, racks and accessory equipment shall be cleaned and sanitised at appropriate
intervals.
Feed and water used for the animals shall be analysed periodically to ensure that
contaminants known to be capable of interfering with study and reasonably expected to be
present in such feed or water are not present in levels above those specified in the protocol.
Documentation of such analyses shall be maintained as raw data.
If any pest control materials are used, the use shall be documented. Cleaning and pest
control materials that interfere with the study shall not be used.
58
Subpart F - Test and Control Articles
Test and control article characterization
The identity, strength, purity, and composition or other characteristics which will
appropriately define the test or control article shall be determined for each batch and shall be
documented.
Methods of synthesis for test and control articles shall be documented by the sponsor or
the testing facility.
59
Each storage container for a test or control article shall be labelled by name, chemical
abstract number, or code number, batch number, expiration date, if any, and, and, where
appropriate, storage conditions necessary to maintain the identity, strength, purity, and
composition of the test or control article.
60
Test and control article handling Procedures shall be established for a system for the
handling of the test and control articles to ensure that:
There is proper storage.
Distribution is made in a manner designed to preclude the possibility of contamination,
deterioration, or damage.
Proper identification is maintained throughout the distribution process.
The receipt and distribution of each batch is documented. Such documentation shall
include the date and quantity of each batch distributed or returned.
61
Subpart G - Protocol for Conduct of a Non- clinical Laboratory Study

Each study shall have an approved written protocol that clearly indicates the objectives
and all methods for the conduct of the study.
The protocol shall contain:
A descriptive title and statement of the purpose of the study.

Identification of the test and control articles by name, chemical abstract number, or code
number.
The name of the sponsor and address of the testing facility
62
The number, body weight range, sex, source of supply, species, and age of the test system.
The procedure for the identification of the system.
A description of the experimental design, including the methods for the control bias.
Each dosage level to be administered and the method and frequency of administration.
The records to be maintained.
63
The non-clinical laboratory study shall be conducted in accordance with the protocol.
The systems shall be monitored in conformity with the protocol.
Records of gross findings for a specimen from post-mortem observations should be
available to a pathologist when examining that specimen histopathologically.
Any change in these entries shall be made so as not to obscure the original entry, shall
indicate the reason for such change, and shall be dated and signed.
64
Subparts J- Records and Reports

Reporting of non-clinical laboratory study results
A final report shall be prepared for each nonclinical laboratory study and shall include
Name and address of the facility performing the study and the dates
Statistical methods employed for analysing data.
The test and control articles identified by name, code number, strength, purity, and
composition or other characteristics.
65

Stability of the test and control articles under the conditions of administration
A description of the methods used.
A description of the test system used.
A description of the dosage, frequency, route of administration, and duration.
The name of the study director, other scientists, supervisory personnel involved in the
study.
66

A description of the transformations, calculations, or operations performed on the data, a

summary and analysis of the data, and a statement of the conclusions drawn from the
analysis.
The locations where all raw data, and the final report are to be stored.
The statement prepared and signed by the quality assurance unit.
67

The final report shall be signed and dated by the study director.
Corrections or additions to a final report shall be in the form of an amendment by the

study director.
The amendment shall clearly identify that part of the report that is being added to or
corrected and the reasons for the correction or addition, and shall be signed and dated by the
person responsible.
68

Storage and retrieval of records and data
All raw data, documentation, protocols, final reports, and generated as a result of a non-
clinical laboratory study shall be retained.
There shall be archives for orderly storage and expedient retrieval of all raw data,
documentation, protocols, specimens, and interim and final reports.
69

Storage and retrieval of records and data
An individual shall be identified as being responsible for the archives.
Only authorised personnel shall enter the archives.
Material retained or referred to in the archives shall be indexed to permit expedient

retrieval
70
71

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B.

Pharm- Third Year

Pharmaceutical Quality Assurance (PQA)

U3.2: Good Laboratory Practices

Good Laboratory Practices & Role of CPCSEA

GOOD LABORATORY PRACTICES

Good Laboratory practices can be defined as

The goal is to certify that every step of the analysis is valid.

The requirement to formulate study plan with a defined scientific purpose.

(b) A training record of all the personnel shall be maintained.

(b)The analytical instruments shall be housed in dust free environment, conditions of

(e) A progress register for non-functional equipment shall be maintained.

(ix) frequency of maintenance

5- CHEMICALS AND REAGENTS

5- CHEMICALS AND REAGENTS

(i) Name of the analyst who prepared solution

7- MAINTENANCE and CALIBRATION

The quality system shall be designed to ensure the following objectives:-

The quality system shall be designed to ensure the following objectives:-

(c) It helps in early detection and correction of non conformities.

(e) It shall have a documented quality policy for the organisation.

11- MANAGEMENT REVIEW

the minimum in respect of the following:

(1) sample handling;

(3) record keeping, reporting, storage and retrieval of data;

final report reviews; 29

(6) routine inspection of cleaning, maintenance, testing, calibration and standardization of

(7) action to be taken in respect of equipment failure;

(8) analytical data methods;

(9) health and safety protection (precautions)

(10) animal room preparation

(11) animal care

condition of sterility room);

(13) use and storage of reference standard’s

(14) Procurement of stores and equipment; (chemical and reagents/solvents)

(15) monitoring of testing of samples

– easy to write SOP but difficult to comply

(16) document control

(18) corrective and preventive action;

(19) working procedure (test methods);

(20) training manual.

(c) The specification archive shall contain the following:-

GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

Good Laboratory Practice for Nonclinical Laboratory Studies

Good Laboratory Practice for Nonclinical Laboratory Studies

Although GLP originated in the United States , it had a worldwide impact.

Good Laboratory Practice for Nonclinical Laboratory Studies

They eventually started making GLP regulations in their home countries.

In 1981 an organization named

High Quality and Reliable Test Data

Good Laboratory Practice for Nonclinical Laboratory Studies

1. Subpart A - General Provisions Scope

Good Laboratory Practice for Nonclinical Laboratory Studies

1.Subpart A - General Provisions Scope

Inspection of a testing facility

Good Laboratory Practice for Nonclinical Laboratory Studies

Sub part B - Organisation and Personnel

Good Laboratory Practice for Nonclinical Laboratory Studies

Sub part B - Organisation and Personnel