Good Laboratory Practice (GLP) regulations are applied to non-clinical safety of study items contained in pharmaceutical products, cosmetic products, veterinary drugs, devices as well as food additives. The purpose of testing these items is to obtain information on their safety with respect to human health and environment. GLP is also required for registration purpose and licensing of pharmaceuticals, pesticides, food additives, veterinary drug products and some bio-products.
3. Good laboratory practices -
“A quality system related with the organizational process and the conditions under which non-
clinical health and environmental safety studies are planned, performed, monitored, recorded,
archived and reported.”
GLP describes good practices for non-clinical lab studies that support research or marketing
approvals for FDA-regulated products.
Purpose of Good laboratory practices –
The principles of good laboratory practice (GLP) is to support the development of quality and
validity of test data used for determining the safety of chemicals and chemical product.
4. Objectives of Good laboratory practices –
• Development of quality test data
• Improve the protection of human health and environment
• Avoid technical barrier
• Comparable quality of test data to avoid duplicative testing
5. • Principles of Good laboratory practice -
Test facility organization and personnel
Quality assurance program
Meeting the requirements of the test facility
Appratus,material and reagents
Test system
Test and reference items
Standard operating procedures.
Performance of the study.
Reporting of study results
Storage and retention of records and materials.
6. 1. Test facility organization and personnel –
a) Test facility management’s responsibility –
• Well educated or qualified personnel.
• Appropriate facilities,equipments and materials are available.
• Test facility should be of appropriate size,costruction and location to meet requirement of
study.
• Ensure that personnel clearly understand the function that they are to perform.
• Valid standard operating procedures are established.
• Ensure maintenance of records of the qualification, training and experience of individual.
• Ensure that study director has made the approved study plan.
7. b) Principal investigator’s responsibilities –
• Investigator will ensure that study conducted in accordance with applicable principles
of GLP.
• Approve the study plan and any amendments and SOP’s are available to study
personnel.
c) Study directors responsibility –
• Study director has overall responsibility for technical conduct of study and fir
interpretation,analysis,documentation and reporting of results.
• Study director has responsibility of for overall quality and integrity of study.
8. d) Study personnel responsibilities –
• Personnel involved in the study must be knowledgeable in those parts of principles of
GLP.
• Access to the study plan and appropriate SOP’s
• Record raw data.
• Study personnel are responsible for quality of their data.
• Exercise health precautions to minimize risk.
• Ensure the integrity of the study.
9. 2. Quality assurance program –
• Responsibilities of QA personnel –
• Access to the updated study plans and SOP’s
• Documented verification of compliance of study plan to GLP principles.
• Inspection to determine compliance of the study with GLP principles.
3 types of inspection
a) Study based inspection
b) Facility based inspection
c) Process based inspection
• Inspection of final reports for accurate and full description.
• Report the inspection result to management.
10. 3.Facilities –
• Should have sufficient no.of rooms or areas
• Suitable rooms should be available for diagnosis,tratment and control of diseases
• There should be storage rooms or areas as needed for supplies and equipment
• Separate areas for receipts and storage of test and reference items
• Should ensure safe storage for Hazardous substance
• Handling and disposal of wastes should be carried out in such a way as not to jeopardies
the integrity of studies
11. 4. Appratus,material and reagent –
• Validated computerized system used for the generation, storage and retrieval of data and for
controlling environmental factors (Humidity , Temperature)
• Apparatus used in a study should be periodically inspected,cleaned,maintained, calibrated
according to SOP’s
• Apparatus and materials used in a study should not interfere adversely with test systems.
• Chemicals, reagents and solution should be labelled to indicate identity, expiry date and
storage instruction.
12. 5. Test system –
a) Physical / Chemicals –
• Apparatus used for generation of physical or chemical data should be suitable
located and of appropriate design and adequate capacity.
• The integrity of Physical or chemical test system should be ensured.
b) Biological –
• Proper conditions for storage,housing,handling and care of biological test sample.
• Isolation of newly received animal and plant test system until health status is
evaluated.
• Records of source, date of arrival and arrival condition of test system should be
maintained.
• During use, housing or containers for test system should be cleaned and sanitized at
appropriate interval.
13. 6. Test and reference items –
a) Receipt,handling,sampling and storage –
• Records for date of receipt, expiry date, quantities received and used in studies.
• Handling, sampling and storage procedures to ensure homogeneity and stability and avoid
contamination or mix-up.
• Identification information on storage container (expiry date, some storage instruction)
*Characterization –
• Each test and reference item should be appropriately identified .
(e.g.- CAS no.,Code,name,biological parameter)
• Each batch of test or reference items should have identity, batch
no.,purity,composition,concentration.
• Stability of test and reference items under storage and test condition should be known for all
studies.
14.
15. 7.Standard operating procedure –
SOP’s should be available for following categories
a) Test and reference items –
• Receipt,identification,labelling,handling,sampling and storage
b) Appratus,materials and reagents –
• Apparatus – Use,maintainance,cleaning and calibration
• Computerized system – Validation,operation,maintainance,security,change control and back-
up
• Materials, Reagents and solution – Preparation and labelling
c) Record,reporting,storage and retrieval –
Coding of studies, data collection, preparation of reports, indexing system and handling of data.
d) Test system –
• Procedure for receipt.
• Test system preparation, observation and examination before, during and at conclusion of study.
16. 8. Performance of study –
• For each study a written plan should exist prior to initiation of study. The study plan should be
approved by dated signature of study director verified for GLP compliance by QA personnel.
• Deviation from the study plan should be described,explained,acknowledged and dated in timely
fashion by study director or principal investigator.
*Content of study plan –
a) Identification of the study, the test item and reference item –
• A descriptive title
• Nature and purpose of study
• Identification of test item by code or name (IUPAC name, AS no.)
b) Information concerning the sponsor and test facility –
• Name and address of ( sponsor, test facilities, test sites, study director and principal director )
17. c) Dates –
• The date of approval of study plan by signature of study director, the test facility
management and sponsor.
• Experimental starting and completion dates.
d) Record -
*Conduct of study –
• Study to be conducted in accordance with study plan.
• All data generated during the conduct of the study should be recorded accurately.
These entries should be signed and dated.
• Any change in raw data should be made should indicate the reason for change and
should be dated and signed.
18. 9. Reporting of study results –
• Submit final report for each study.
• Approval by study director.
• Correction,addition,amendments to be signed and dated by study director.
*Content of final report –
a) Identification of study –
• Descriptive title, identification of test and reference item, purity and stability.
b) Information on sponsor and test facility –
• Name and addresses of sponsor, test facility, study director, scientists involved to the
study.
c) Experimental starting and completion date –
d) Quality assurance program statement –
e) Description of materials and test methods –
19. f) Results –
g) Storage – Sample,rederance items, raw data, final reports
20. 10. Storage , retention of records and materials –
• Retention period to be defined.
• If any study material is disposed of before expiry the reason to be justified and
documented.
• Records of all inspection performed by QA program and master schedules.
• Records of qualification,training,experiences and job description of personnel.
• Record and report of maintenance and calibration of apparatus.
21. • Reference –
1. Isin Akyar (2011) GLP Good Laboratory Practice , Modern Approaches to Quality Control
Dr.Ahmed Badr Eldin (ED) ,ISBN : 978-953-307-971-4,in Tech
Available from http://www.intechopen.com/modernapproaches-to-quality-
control/glp-good-laboratory-practice
2. P.P.Sharma & apos;How to Practice GLT & apos;Vandana Publication
3. Good Laboratory Practice regulations Forth edition,edited by Sandy Weinberg
