Review of Batch Manufacturing Rerecords

1.0 OBJECTIVE

To lay down a procedure for review of batch manufacturing records. 

2.0 SCOPE

This procedure is applicable to review of batch manufacturing records at Company Name.

3.0 RESPONSIBILITY

3.1 Executive-Quality Assurance

3.2 Head-Quality Assurance 

4.0 PROCEDURE 

4.1 All the batch manufacturing records shall be reviewed by Quality Assurance to determine compliance with all established approved and written procedures before a batch is released for distribution. Any discrepancy or failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated.

4.2 Any handwritten change to the equipment’s, materials, weights, procedures and process parameters shall be signed and dated by the Production Executive/ Production Manager / Production head and accompanied by justification and approved by Quality Assurance head.

4.3 A written record of investigation shall be made and shall include the conclusion and follow-up. Following parameters shall serve as guidelines while carrying out appropriate review of batch manufacturing records. 

4.4 Batch manufacturing details: 

4.4.1 Head Quality Assurance / Quality Assurance executives shall review the following records for their correctness and compliance 

4.4.1.1Issue of batch manufacturing records by Quality Assurance with signature and date of issue. 

4.4.1.2 Batch Manufacturing records issued are appropriate and in accordance with the current and approved Master copy of BMR. 

4.4.1.3 Each significant step in the manufacturing, processing is accomplished including dates and identity of major equipments used. 

4.4.1.4 Specific identification of each batch of in-process material.

4.4.1.5 Components used during the processing or manufacturing are weighed correctly and weighing operation witnessed by the other person. 

4.4.1.6 In process Quality Control checks and results. 

4.4.1.7 Process control checks and results. 

4.4.1.8 Calculations of yields at appropriate phases of manufacturing or processing and the percentage of theoretical yield and limits established and indicated in BMR.

4.4.1.9 Each critical step in the manufacturing and processing is witnessed by the other person as indicated in batch manufacturing records. 

4.4.1.10 Reconciliation’s records.

4.4.1.11 Specimens of all labelling used in packing and signed by packaging supervisor and Quality Assurance executive. 

4.4.1.12 Description of product containers and closures used and their identification.

4.4.2 General 

4.4.2.1 There shall be no white ink used for correction on any written matter.

4.4.2.2 The handwritten changes shall be made only after putting a cross line on the matter to be corrected and the signature of the person who made the changes and date. 

4.4.2.3 All the entries shall be appropriately registered and shall be signed with date. 

4.4.2.4 There shall be no overwriting on any of the entries in batch records.

4.4.2.5  Each component shall be added to the batch by one person and independently verified by a second person whose signature shall be recorded on the batch manufacturing record. 

4.4.2.6 After auditing the batch manufacturing records including those for packing and labelling and analytical records, and in-process samples Head Quality Assurance shall release / reject the batch and sign with date on the batch records. 

4.4.2.7 All the logbooks, raw data books shall be counter checked while auditing the batch records, and analytical records. 

4.4.2.8 NCR shall be raised, if any unexplained discrepancies or the failure of a batch or any of its components to meet any of the specification with conclusion and follow up.

5.0 ABBREVIATIONS

5.1 NCR-Non conformance report

5.2 BMR-Batch Manufacturing record 

6.0 ANNEXURE: Nil  

7.0   CHANGE HISTORY