Good Laboratory Practices Paras Shah

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.

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.

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

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

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

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

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

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.

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

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.

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

Management Head Sales QA Inspection Test Head QC IPQC Head Production

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

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

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

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

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

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

Subpart F: Test and Control Articles Characterization Handling

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

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

Sampling Plans n Plan p Plan r Plan Reserve samples