Good Laboratory Practices For Pharmaceutical Laboratories
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| Aspects to consider |
Key Pointers |
| Equipment |
- 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
|
| 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
|
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