SOP For Control of Completed Batch Production
- OBJECTIVE :
- To provide a procedure for the proper control of completed Batch Production Records (BPR) after 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 Head of Quality Assurance department shall be stored in Documentation cell.
- Officer- Documentation shall check for the Product Name, Batch Number and Total number of pages in each BPR received.
- Enter the details of BPR in 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 QA department.
- Issuing of a specific BPR for specific reasons can be done after obtaining authorization from the Head of Quality Assurance Department.
- Whoever requires to issue a BPR, shall fill the ‘BPR Issue Request’ (annexure-2) slip, available in Documentation cell and forward to the Head of Quality Assurance Department.
- Each BPR associated with a batch of a drug product shall be retained for atleast 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 |
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| S No.
|
Product name
|
Batch No.
|
No. of
pages |
Expiry
date |
Retention
date |
Received by
Sign |
Date |
Disposed by
Sign |
Date |
Remarks
|
Annexure-2
Specimen format of “BPR Issue Request”
|
BPR ISSUE REQUEST |
||
| Product : | ||
| Batch No. : | ||
| Requested by : | Date : | |
| Purpose : | ||
| Authorised by : | Date : | |
| Issued by : | Received by : | Date : |
| No. of Pages : | ||
| Returned by : | Received by : | Date : |
| No. of Pages : | ||
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