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.
- 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.
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
Date Revision Number Reason for Revision – 00 New SOP
Specimen format of “BPR Control Register”
BPR CONTROL REGISTER
Specimen format of “BPR Issue Request”
BPR ISSUE REQUEST
|Batch No. :|
|Requested by :||Date :|
|Authorised by :||Date :|
|Issued by :||Received by :||Date :|
|No. of Pages :|
|Returned by :||Received by :||Date :|
|No. of Pages :|
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