Good Laboratory Practices for Pharmaceutical Laboratories

Good Laboratory Practice contains different principles which are designed to ensure and promote consistency, quality, safety, reliability and integrity of chemicals during non-clinical and laboratory testing.

Equipment

• SOP s must be present for each instrument
• They must be stored under recommended environmental conditions & calibrated regularly
• Light & electrical systems must be as per regulations & not overloaded
• Glassware must be calibrated & certified for use

Chemicals & reagents

• Storage of chemicals must be done as per the MSDS sheet
• All chemicals must be appropriately labelled and stored with their MSDS sheet
• Any transfer must occur with a proper audit trail
• Any prepared solution must be labelled and dated with an expiry date
• Mouth pipetting is unacceptable; use a rubber suction pump instead

Organisation & personnel

• Every individual in the laboratory must have the necessary qualification and training to participate
• Sufficient number of personnel must be employed
• Every individual must be given personal protective equipment (PPE)
• A well-defined organogram of the laboratory must be drawn up and assigned based on the roles required

Documentation

• Every single procedure, event, and entry/ exit must be recorded
• SOPs for usage, maintenance, and calibration must be provided for each equipment
• All samples/ reagents must be labelled and stored as per guidelines
• Examples: Sampling, Validation, Testing, Data recording, Operation, etc.

Quality Control

• For samples: Documentation of receipt, usage and storage
• Sampling procedure and testing methodologies used must be recorded

Safety

• Personnel must be required to undertake required immunisations and protective measures before beginning their experiments
• Facilities & accessories must be present for first aid, drug testing, accidents such as water leakage or fires

Auditing Procedure

• A dedicated committee must be instituted to maintain the quality standards of the laboratory
• It must be done in accordance with GLP requirements