SOP on Good Laboratory Practices (GLP)
PROCEDURE
Principles and Objectives of Good Laboratory Practices
Ensure consistent quality through well-defined procedures and accurate record keeping.
Maintain integrity by recording all results exactly as observed without manipulation.
Ensure accuracy in all analytical activities to minimize errors and avoid rework.
Demonstrate diligence by combining care, accuracy, and honesty in all laboratory operations.
Ensure that all analytical methods and activities are validated and capable of producing reliable results.
Premises
Maintain laboratory areas in a clean, hygienic, and orderly condition at all times.
Ensure instruments are clean and properly covered when not in use.
Install analytical balances on stable, vibration-free platforms away from air drafts.
Monitor and record temperature and relative humidity at least twice daily.
Maintain workbenches in a clean and organized condition.
Keep all passageways clear of obstructions.
Ensure availability of only current, approved, and controlled documents.
Use only qualified instruments as per approved procedures.
Assign unique identification numbers to all instruments.
Ensure all instruments are calibrated prior to use.
Clearly label instruments under maintenance and restrict their use.
Maintain SOPs and logbooks at designated and easily accessible locations.
Ensure SOPs cover all laboratory activities and operations.
Perform testing of materials/products strictly as per specifications and STPs.
Perform periodic maintenance, calibration, and verification of instruments.
Maintain all work areas free from clutter and unnecessary materials.
Conduct periodic internal audits/self-inspections.
Review and update documents periodically.
Maintain proper indexing, filing, and storage of records for easy retrieval.
Personnel
Personnel shall wear designated laboratory uniforms or aprons.
Appropriate footwear or shoe covers shall be used within laboratory areas.
Eating, drinking, and smoking are strictly prohibited in the laboratory.
Follow defined entry and exit procedures at all times.
Adhere strictly to all safety guidelines and instructions.
Use appropriate Personal Protective Equipment (PPE) as required.
Personnel shall be aware of the risks and consequences of non-compliance with safety procedures.
Laboratory Practices
General Practices
Maintain a daily plan and status record of analytical activities.
Record all observations and data contemporaneously during analysis.
Protect all documents and records from chemical exposure or damage.
Ensure clarity and correctness while recording data and selecting options.
Glassware Handling
Use Class ‘A’ glassware or calibrated Class ‘B’ glassware.
Clean and dry glassware as per approved SOPs.
Store glassware in dust-free conditions.
Use only clean, dry, and intact glassware.
Inspect glassware for defects prior to use.
Rinse glassware with appropriate solvents when required.
Chemicals and Reagents
Label all chemicals and reagents as per approved SOP.
Inspect reagents periodically (at least once in six months) for any deterioration.
Discard any chemicals or reagents showing signs of contamination or change.
Verify validity/expiry before use; expired materials shall not be used.
Check validity of standards and prepared solutions prior to use.
Ensure proper labeling of reagents with strength, preparation date, and validity period.
Instruments
Verify calibration status of instruments before use.
Update instrument status labels/boards regularly.
Sample and Standard Handling
Store samples under specified storage conditions.
Perform LOD or water content determination on the same day as assay preparation, where applicable.
Maintain prepared solutions under specified protective conditions.
Handle standards as per SOPs and labeling instructions.
Good Documentation Practices (GDP)
Record entries in logbooks and documents contemporaneously.
Correct errors by drawing a single line, with signature and date (no overwriting permitted).
Use date format as DD/MM/YYYY.
Avoid overwriting or erasing entries.
Do not alter critical entries such as weights, batch numbers, or test values.
Limit corrections to a maximum of three per page.
General Laboratory Discipline
Wipe burette and pipette tips before dispensing.
Clean the work area before and after analysis.
Replace desiccants when required.
Use clean tools for sampling.
Report any incident or abnormality immediately to the supervisor.
Handle spillages as per approved SOP.
Return all materials and equipment to designated storage after use.
Remove used glassware after completion of analysis.
Shutdown Procedure
Switch off all electrical equipment before leaving the laboratory.
Ensure laboratory is secured and hand over keys to security personnel after closing.
REFERENCES
- World Health Organization (WHO) – Good Practices for Pharmaceutical Quality Control Laboratories
- US Food and Drug Administration (USFDA) – GLP Regulations
- Central Drugs Standard Control Organization (CDSCO) Guidelines
- Indian Pharmacopoeia (IP)
ABBREVIATIONS
- GLP – Good Laboratory Practices
- SOP – Standard Operating Procedure
- STP – Standard Test Procedure
- LOD – Loss on Drying
- PPE – Personal Protective Equipment