SOP For Control of Completed Batch Production
OBJECTIVE :
To provide a procedure for the proper control of completed Batch Production Records (BPR) after the release of finished drug products for distribution.
RESPONSIBILITY :
Officer – Quality Assurance.
Officer – Documentation.
Head of Quality Assurance Department to ensure compliance.
PROCEDURE
All completed Batch Production Records (BPR) duly approved by the Head of the Quality Assurance department shall be stored in the Documentation cell.
Officer- Documentation shall check for the Product Name, Batch Number, and a Total number of pages in each BPR received.
Enter the details of BPR in the BPR control register (annexure-1).
Photocopying of any BPR or any page from BPR shall be strictly prohibited unless written permission is obtained from the Head of the QA department.
Issuing a specific BPR for specific reasons can be done after obtaining authorization from the Head of the Quality Assurance Department.
Whoever requires to issue a BPR, shall fill out the ‘BPR Issue Request’ (annexure-2) slip, available in the Documentation cell, and forward it to the Head of the Quality Assurance Department.
Each BPR associated with a batch of a drug product shall be retained for at least one year after the expiration date of the batch.
In the case of drug products lacking expiration dating, each BPR shall be retained for 3 years after the distribution of the batch.
Forms and Records (Annexures)
Specimen format of “BPR Control Register” – Annexure 1.
Specimen format of “BPR Issue Request” – Annexure 2.
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control, engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Annexure-1
Specimen format of “BPR Control Register”
PHARMA DIVISION
BPR CONTROL REGISTER
- S No.
- Product name
- Batch No.
- No. of pages
- Expiry date
- Retention date
- Received by
- Disposed of by
Annexure-2
Specimen format of “BPR Issue Request”
BPR ISSUE REQUEST
- Product :
- Batch No. :
- Requested by :
- Purpose :
- Authorized by :
- Issued by :
- Received by :
- No. of Pages :
- Returned by :
- Received by :
- No. of Pages :