The purpose of this SOP is for Receiving of current updates on Pharmacopoeias in Quality Control Department.
This SOP is applicable to Quality Control Department at manufacturing facility .
- Authorized designee of Quality Control department shall be responsible for Receiving / reviewing of current updates on Pharmacopoeias.
- The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
|4.1 Authorized designee of Quality Control department shall initiate to procure the pharmacopoeia in co- ordination with Regulatory Affair /Corporate Quality Assurance department.|
|4.2 Quality Control shall coordinate with Regulatory Affair /Corporate Quality Assurance for Procurement of pharmacopoeias (whenever any change comes in any pharmacopeia (USP, BP, EP, IP etc) or for new edition /supplements).|
|4.3 After receiving the new pharmacopoeia update the list and obsolete the old pharmacopeia and submit the old pharmacopoeia in Quality assurance department.|
|4.4 In the case of supplements the Regulatory Affair Department shall send the affected monograph for updating to QC.|
|4.5 After receiving of new pharmacopoeia and supplements, all changes shall be made in respective documents before the effective date of pharmacopoeia.|
- TRAINING :
Trainer : Head – Quality Control
Trainees : Quality Control chemist / Sectional Heads
Controlled Copy No. 1: Head of Department – Quality Assurance
Controlled Copy No. 2: Head of Department – Quality Control
Original Copy : Head – Quality Assurance
- REFERENCES (S):
- REVISION HISTORY:
|Sr. No.||Revision No.||Change Control Number||Details of Revision||Reasons(s) for Revision|
|1||00||—-||New SOP||New SOP|