Standard Operating Procedure of Compilation, Review and Retention of Batch Manufacturing Record is describe in this post.
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1. PURPOSE
To describe the system of
1.1 Issuing batch manufacturing record to all sections of Production department.
1.2 Compilation, review, closure and retention of batch manufacturing record & related record. The system is followed to ensure that each step during batch processing is in compliance with written procedures, GMP & Regulatory Requirements.
2. SCOPE
This procedure is applicable to Batch Manufacturing record (BMR) and related record of all products manufactured and packed in Pharmaceuticals.
3. RESPONSIBILITY
3.1 Production department is responsible for timely raising request for issuance of Batch Manufacturing record on “BMR ISSUANCE REQUEST FORM”.
3.1.1 Production department sends the request form to Quality Assurance department which upon receiving the request issues the new BMR according to detail given by production (e.g. Batch No., Batch Size, Mfg. Date & Exp. Date, Price per unit (e.g. for Ampoule) & price per pack size, and assay of the Active Pharmaceutical Ingredients (API) if required etc. on the request form.
3.1.2 Production Manager ensures that activity is performed in timely manner and the information provided on “BMR ISSUANCE REQUEST FORM” is correct and complete.
3.2 Quality Control department is responsible for timely testing, releasing and submitting the complete In-process Test Reports to Production department and Finished Goods Report & Microbiological Sterility Testing Report to Q.A department after complete testing of the representative Sample from batch.
3.2.1 QC Manager is responsible that all sample receiving and testing activities are performed accurately and timely.
3.3 Q.A department is responsible for issuance, review and retention of the record.
3.3.1 Q.A officers are responsible for review of the complete batch manufacturing document, verification of the completion status along with information traceability and checking the retention of BMR at regular intervals.
3.3.2 Q.A Manager ensures that all activities like issuance, compilation, review, closure and retention of BMR is performed on time.
4. MATERIAL & EQUIPMENT
4.1 Controlled stamp (Red Coloured)
4.2 Released for Dispatch stamp (Red Coloured)
4.3 Batch Manufacturing Record (BMR)
4.4 Permanent Black marker
5. PROCEDURE
5.1 COMPILATION OF BATCH RECORD
5.1.1 After testing of in-process samples, Q.C department sends the test report to respective section. Q.C Manger is responsible to check that all the tests mentioned in the specifications are performed and results are within specified limits along with release/reject label.
5.1.2 During batch manufacturing relevant Production Officer reviews and completes the BMR and related records (e.g. Equipment & Area Cleaning control, Q.C Test report, In-process check sheets, Product Sampling Request, etc.) and marks all available completed documents on BMR Document check list. QA officer verifies that BMR is completed timely.
5.1.3 After completion of BMR Production Officer conducts the Process and documents review. Then BMR document is provided to Production Manager for detailed review. Production Manager is responsible to check that all the process parameters are correctly performed, results recorded, all relevant record forms attached, yields correctly calculated and reason mentioned in case of yield variation from theoretical yield, problem observed in the batch is investigated and recorded, mentioned in the BMR. After Production Manager review, completed BMR and all related records is submitted to Q.A department.
5.1.4 After testing of FG product, Finished Goods Analysis Report is submitted by Q.C to Q.A department after batch is finally released. Q.C Manger is responsible to check that all the tests mentioned in the specifications are performed and results are within specified limits.
5.1.5 Q.A Record keeper enters in its respective log and place in relevant BMR shipper.
5.2 REVIEW OF BATCH RECORD
5.2.1 Q.A Officer reviews all batch records (BMR and related records) to check that;
a. BMR is accurately filled.
b. All results of testing are within specified limits.
c. Completed forms with respect to; all blanks filled in, all choices marked, all initials/ signatures/ second signatures present, all data entered with indelible ink are attached.
d. All dates are accurate.
e. Corrections (where required) are done by crossing out of original with a single line, initials and date.
5.3 BATCH RELEASED FOR DISPATCH
5.3.1 Request for Dispatch of Finished Goods is sent by FG Warehouse to QA.
5.3.2 QA department checks following,
a. BMR received and complete
b. Batch is released by QC and Finished Goods Release Report is received in QA.
c. All the information is sufficient for the approval of dispatch.
5.3.3 After satisfactory checking of above items, each shipper of batch is stamped with “Released for Dispatch” stamp and dispatched for sale from F.G Warehouse.
5.6.4 Request for Dispatch is kept by QA department.
5.4 RETENTION OF BATCH RECORD
5.4.1 When BMR is completed with attached relevant documents, then Q.A Record keeper close it in BMR Issuance and receiving log.
5.4.2 Q.A Record keeper places each BMR of each product in Shipper which is labelled with BMR Shipper Label.
5.4.3 This label is updated by Q.A Record keeper when
a. A new Batch Manufacturing Record is shifted into it.
5.4.4 Each Batch Manufacturing Record is retained in Q.A record Room till its expiry plus one year.
5.5 REQUEST FOR BATCH RECORD
5.5.1 Any section head/officer, who demands for any BMR, document/related record from Q.A department, fills the “Request Form for Batch Manufacturing Record”.
5.5.2 Batch Manufacturing Record handing over and return record is maintained on this form.