SOP For Control of Completed Batch Production

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

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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