Transcription of SOP List (Quality Assurance Division) SOP Index No. …
1 Central Drugs Standard Control Organization Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002. SOP List (Quality Assurance Division) SOP Index No. QA-01. SOP Title SOP No. 1. SOP for SOPs QA-GNL-001. 2. Code of Ethics for GMP Inspector/Specialist (Internal) QA-GNL-004. 3. Procedure for Vaccine SpecificTraining QA-GNL-007. 4. Procedure for Preparation of Inspection Book QA-GNL-009. 5. Criteria for Follow-up Action Following Inspection QA-GNL-014. 6. Procedure for issuance of WHO-GMP Certificate QA-GNL-015.
2 7. Procedure for Sampling of Drugs having Suspected QA-GNL-016. Quality Defects 8. Procedure for sampling of vaccine in case of Adverse QA-GNL-017. events following immunization or complaint 9. Procedure for handling appeals QA-GNL-019. 10. Procedure for Recall and Rapid Alert System for Drugs QA-GNL-021. including Biological & Vaccines 11. Procedure for selection of external expert in CDSCO and QA-GNL-023. conducting expert meeting Procedure for allotting file number after receipt of 12. various applications in CDSCO's Vaccine and Biological QA-GNL-025. section 13. Procedure for handling of pre- proposal meeting on QA-GNL-026.
3 Technical issues with DCGI and associated staff 14. Procedure for Receiving and Distribution of Applications QA-GNL-028. by the Central Registry Unit 15. Procedure for Conducting External Audit QA-GNL-030. 16. Procedure for managing guidelines specific to functions QA-GNL-031. of CDSCO. 17. Procedure for Management of CDSCO Website QA-GNL-032. Procedure for detection and sampling of Misbranded, 18. Adulterated, Spurious and Not of Standards Quality QA-GNL-033. Drugs 19. Procedure for expedited review and accelerated approval QA-GNL-034. SOP for Publishing the list of names of vaccine 20.
4 Manufacturer in the CDSCO website whose license have QA-GNL-035. been suspended / cancelled SOP for Publishing the list of names of vaccine 21. manufacturer in the CDSCO website whose QA-GNL-036. manufacturing license have been cancelled alongwith summary report
