Good Laboratory Practices for Pharmaceutical Laboratories

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