Good Laboratory Practices For Pharmaceutical Laboratories

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Aspects to consider Key Pointers
  • SOPs must be present for each instrument 
  • They must be stored under recommended environmental conditions & calibrated regularly
  • Light & electrical systems must be as per regulations and 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
  • 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 
  • 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

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