1. Good Laboratory Practices
Paras Shah

2. What is it ?
GLP define a set of rules and criteria for a quality system concerned with the organisational process and the condition under which non-clinical health and environmental safety studies are planned, monitored, recorded, archived and reported.

3. Objectives:
GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study.
GLP also makes sure that data is traceable.
Promotes international acceptance of tests.

4. Subpart A : General Provisions
Subpart B : Organization and Personnel
Subpart C : Facilities
Subpart D : Equipment
Subpart E : Testing Facilities Operation
Subpart F : Test and Control Articles
Subpart G : Protocol for and Conduct of a Non clinical Laboratory Study
Subpart H and I : Reserved
Subpart J : Records and Reports
Subpart K : Disqualification of Testing Facilities

5. Subpart A: General Provisions
Scope
Definitions
Applicability to studies performed under grants and contracts
Inspection of a testing facility

6. Subpart B: Organization and
Personnel
Identification of quality activities
Assigning responsibility for performing identified quality activities
Dividing total work pile into parcels of work known as jobs
Defining authority and responsibility
Defining relationship of jobs
Co-ordination
Study director

7. Top Management Develop company quality and major quality objectives
Overall company quality plan
Design organization structure for carrying out the plan
Design system of product quality evaluation, audits and surveillance

8. Head of Quality Control Dept.
Starting materials, packaging, intermediate, bulk and finished products are approved or rejected
Batch records are evaluated
Sampling instructions, specifications, test methods and other quality control procedures are approved
Departments, premises and equipments are maintained
Validation of analytical methods and calibration

9. Initial and continuing training to personnel working in quality control departments is carried out
Manufacturing and testing environments are maintained
Records are retained for the period as required under national law
Requirements of GLP are complied.

10. Process Control: To prepare plan for process control and operation
TO conduct process inspection and surveillance
Investigate causes of out of control conditions

11. Inspection and Test Design inspection and test plan
Standardize test procedures
Prepare inspection manual
Prepare inspection job specifications
Conduct inspection and tests as per plan
Investigate causes of sporadic defects, report findings and follow corrections
Prepare reports and results
Initiate action to dispose of nonconforming products.

12. Vendor Relation: Prepare vendor quality relation manual
To prepare plan for conducting vendor quality relation
Conduct survey and analysis to judge quality competence of prospective vendors
Assist vendors
Conduct inspection and test of vendor shipments to generate data
TO rate vendor performance

13. Management
Head Sales QA
Inspection Test
Head QC
IPQC
Head Production

14. Personnel: Qualification, Training and Experience
Personnel in Chemical testing unit, Instrumental testing unit, Microbiological testing unit, Pharmacological testing unit
Training

15. Subpart C: Facilities
Testing facility shall be of suitable size, construction and location to facilitate the proper conduct of non-clinical laboratory studies.
Design and construction features
Animal Care facilities
Away from testing lab
Self-contained ventilation
Areas : Quarantine, Sick animals, Quarters, Food, inoculation, Postmortem

16. Lighting, Sound management
Temperature and humidity
Mice and Rats : 25 degrees and 50-60%
Guinea pigs and Rabbits : 24 & 50-60%
Monkeys: 15.6 – 29.5 and 40-67%
Water supply
Dimension of cages
Bedding
Feeding

17. Subpart D: Equipments Design and material of construction
Instruments for testing
Maintenance and calibration of instruments

18. Subpart E: Testing Facilities
Operation
SOPs in writing
Deviations authorized by director
SOPs: Animal room preparation, Animal care, receipt, identification, storage, handling, mixing and methods of sampling of test and control articles, tests, handling of animals, collection of specimens, data handling, storage, maintenance and calibration, transfer and placement of animals

19. Reagents and solutions : Reputed supplier, certification, tested when received, Storage at specified conditions
Reference standards

20. Subpart F: Test and Control
Articles
Characterization
Handling

21. Subpart G: Protocol for and Conduct of a non-clinical lab study
Guidelines for study data to be submitted to FDA for research and marketing permits

22. Subpart J: Reporting E.g. Tablets and capsules
Analytical report number
Name of the sample
Date of receipt of sample
Batch/Lot number
Description, Identification
Uniformity of weight, Diameter
Any other test
Assay
Signature of analyst
Opinion and signature of the approved analyst

23. Sampling Plans
n Plan
p Plan
r Plan
Reserve samples