SOP For Receiving of current updates on Pharmacopoeias

1. OBJECTIVE:

The purpose of this SOP is for Receiving of current updates on Pharmacopoeias in Quality Control Department.

2. SCOPE: 

This SOP is applicable to Quality Control Department at manufacturing facility .   

3. RESPONSIBILITY:
   1. Authorized designee of Quality Control department shall be responsible for Receiving / reviewing of current updates on Pharmacopoeias.
   2. The Head of Quality Control Department or his designee shall be responsible and implementation of the SOP.
4. PROCEDURE:

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.

5. TRAINING :

 Trainer : Head – Quality Control 

 Trainees             : Quality Control chemist / Sectional Heads

6. DISTRIBUTION:

Controlled Copy No. 1:  Head of Department – Quality Assurance

Controlled Copy No. 2:  Head of Department – Quality Control

Original Copy     :  Head – Quality Assurance

7. ANNEXURE:

            Nil 

8. REFERENCES (S):

Nil 

9. REVISION HISTORY:

Sr. No.	Revision No.	Change Control Number	Details of Revision	Reasons(s) for Revision
1	00	—-	New SOP	New SOP