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

Schedules: Schedule A, Schedule B, Schedule C, Schedule D, Schedule E1, Schedule F, Schedule G, Schedule H, Schedule H1, Schedule I, Schedule J, Schedule K, Schedule L1, Schedule M, Schedule M1, Schedule M2, Schedule M3, Schedule N, Schedule O, Schedule P, Schedule Q, Schedule R, Schedule S, Schedule T, Schedule U, Schedule V, Schedule W, Schedule X, Schedule 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