Schedule L1: Good laboratory practices and requirements of premises and equipment

Schedules: Schedule ASchedule BSchedule CSchedule DSchedule E1Schedule FSchedule GSchedule HSchedule H1, Schedule I, Schedule JSchedule KSchedule L1Schedule MSchedule M1Schedule M2Schedule M3Schedule NSchedule OSchedule PSchedule QSchedule RSchedule SSchedule TSchedule USchedule V, Schedule W, Schedule XSchedule Y


Schedule L and Schedule L1:

Schedule L (Omitted)

Schedule L-1 (Rule 74,78 and 150E):
Schedule L describes the good laboratory practices and requirements of premises and equipments.
  1. General Requirements
  2. Premises
  3. Personnel
  4. Equipments
  5. Chemical and Reagents
  6. Good Housekeeping and Safety
  7. Maintenance, calibration, and validation of equipments
  8. Reference materials
  9. Microbiological Cultures
  10. Quality System
  11. Internal Quality system audit
  12. Management Review
  13. Standard Operating Procedures
  14. Protocols and specifications archive
  15. Raw Data
  16. Storage and archival

For more detail refer Drug and Cosmetic Act

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