BATCH RECORD AUDIT - SOP

OBJECTIVE:

To establish procedure to be followed while auditing the batch production, Batch Packing Records and analytical records

RESPONSIBILITIES:

Manager Quality Assurance / Manager Quality Control and Assurance shall be responsible for carrying out batch records audit as a part of batch - release.

PROCEDURE:

1. All the production records including those for packing and labeling and analytical records shall be audited 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.

2. Any handwritten change to the equipment’s, materials, weights, procedures and process parameters shall be signed and dated by the Asst. Production Manager / Production Manager / Production Incharge and accompanied by justification and approved by Quality Assurance Manager / Change Control Committee.

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 records.

4. Batch Manufacturing Records (BMR):

Manager Quality Assurance / Quality Assurance Inspector shall review and check the following records for their correctness and compliance:

4.1. Issue of batch Manufacturing records formats by Quality Assurance with signature and date of issue.

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

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

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

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

4.6. In process Quality Control checks and results.

4.7. Process control checks and results.

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

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

5. Batch Packing Records:

Manager Quality Assurance / Quality Assurance Inspector shall review and check the following records for their correctness and compliance:

5.1. Issue of batch packing records format by Quality Assurance with the signature and date of issue.

5.2. Batch packing records formats issued are appropriate and in accordance with the current and approved Master copy.

5.3. Inspection of the packing and labeling area before and after use.

5.4. Actual yield and percentage of theoretical yield at appropriate phases of operations as indicated in batch packing records.

5.5. Reconciliation’s records.

5.6. Specimens of all labeling used in packing and signed by packaging supervisor and Quality Assurance Inspector.

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

5.8. Identification of persons performing and supervising or checking each significant step in the operation.

5.9. Results of examinations made as per "Product Inspection" report.

5.10. Any investigation made there of.

6. Batch Analytical Records:

Manager Quality Assurance / Quality Assurance Inspector shall review and check the following records for their correctness and compliance:

6.1. All the analytical reports with protocols from relevant sections are enclosed.

6.2. All the analytical reports with protocols are duly signed by analyst and certified by Manager Quality Control with his opinion / remarks on the tests carried out.

6.3. All the supporting analytical documents are enclosed to the respective analytical reports.

6.4. Dates are entered at appropriate places with signatures.

6.5. Certificates of analysis is enclosed with remarks / opinion of Manager Quality Control and signature of analyst and Manager Quality Control.

7. General:

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

7.2. 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.

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

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

7.5. 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.

7.6. After auditing the batch manufacturing records including those for packing and labeling and analytical records, and inprocess samples Manager Quality Assurance shall release / reject the batch and sign with date on the batch records.

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

7.8. Investigation record shall be prepared 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.