Destruction of Batch Production and Control Records BPCR
1.0 Objective
To lay down a procedure for destruction of Batch Production and Control Records (BPCR).
2.0 Scope
This Standard Operating Procedure is applicable for destruction of Batch Production and
Control Records which include batch manufacturing and batch packing records to be followed at
formulation plants of abc Pvt. Ltd.
3.0 Responsibility
3.1 Officer / Executive QA shall be responsible for destruction of batch production & control records.
3.2 Plant Head shall be responsible for approval of destruction of batch production & control records.
3.3 Head QA / his designee shall give authorization for destruction of batch production & control records and compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
BPCR : Batch Production & Control Record
Mfg. : Manufacturing
Exp. : Expiry
No. : Number
QA : Quality Assurance
5.0 Procedure
5.1 Officer / Executive QA shall destroy the BPCR after five years from the manufacturing date of the product.
5.2 Officer / Executive QA shall prepare a list of batch records, which are due for destruction as per
Annexure-1 for every six months.
5.3 Retain the batches records for which legal samples are taken by any Regulatory Authority
or market complaints are under investigation till the matter get cleared.
5.4 Officer / Executive QA shall take the approval of Head QA and authorization of
Plant Head in a prescribed BPCR destruction format (Annexure-2).
5.5 Officer / Executive QA shall destroy the BPCR with the help of shredder.
5.6 Officer / Executive QA shall make entry in destruction verification report duly sign with date.
5.7 Head QA / his designee shall verify the destruction verification report duly sign with date
6.0 Forms and Records
6.1 Destruction Record of BPCR – Annexure-1
6.2 BPCR Destruction Note – Annexure-2
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Controlled copies – Quality Assurance, Quality Control, Production
and Warehouse.
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
Annexure-2
- process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
-
process validation protocol for methylcobalamin niacinamide and pyridoxine injection
validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
sop for Verification of Weighing Balance
-
Sop for Submitting of Leave Application
sop for Accident Management Procedures
sop for Accident Management Procedures
Cleaning and colour coding of Factory Apparel (Clothes)
Job Responsibilities of Key Personnel
sop for Maintenance of Building
Destruction of Batch Production and Control Records BPCR