Issue, Entry, Review & Control of Batch Manufacturing Records in Pharmaceuticals

Standard Operating Procedure of Issue, Entry, Review & Control of Batch Manufacturing Records in Pharmaceuticals is describe in this post.

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To lay down the procedure for issue, entry, review, release and control of Batch Manufacturing Records by Q.A.

2.0  SCOPE:

This SOP shall be applicable while issue, entry, review, release and control of Batch Manufacturing Records.


3.1  Primary: Q.A. Officer, Q.C. Officer, Production Officer.

3.2  Secondary: Q.A. Manager, Q.C. Manager, Production Manager.


4.1  Head of Quality Assurance Department.

4.2  Head of Production Department.


5.1  Issue of batch manufacturing record (by Quality Assurance):

5.1.1        Based on Production planning, production manager shall decide on the product and the number of batches to be produced in the month.

5.1.2        Production supervisor shall raise the requisition for the batches to be taken for the week and forward it to Quality Assurance.

5.1.3        On receipt of Batch Manufacturing Record issue requisition Q.A. personnel will verify the details entered in the requisition form.

5.1.4        A photocopy of the MASTER COPY of the required Product Batch Manufacturing Records will be taken.

5.1.5        All the pages of the photocopied sheet of Product Batch Manufacturing Record shall be signed and dated by Q.A. personnel.

5.1.6         Check for the correctness of the Batch number by verifying the BMR register.

5.1.7        Enter the details of date, product, batch no., batch size, manufacturing date, expiry date and issued by details in the BMR register.

5.1.8        Check and allot expiry date by referring to master list of product shelf life.

5.1.9        If there is a deviation for change in batch size or any other equipment/ process change raise deviation approval form as per deviation procedure SOP.

5.1.10    Enter the batch no. on all the pages of the BMR and get it authorized by Q.A. Manager or in absence by Q.A. Executive or Q.A. Officer.

5.1.11    Insert the signed batch record in a BMR cover and enter the details of product name, batch number, batch size, manufacturing date and expiry date.

5.1.12    Batch record along with the batch record register shall be sent to production, the production person receiving the batch record should sign on the batch record register to acknowledge the receipt of batch record.

5.1.13    Q.A. person who has issued Batch record shall sign the “issued by” on bath record issue requisition sheet and file the same for future reference.

5.2  Entry of batch manufacturing record (by Production Personnel):

5.2.1        On receipt of BMR Production Manager/ Dy. Production Manager shall check the BMR and sign on the first page.

5.2.2        The calculation sheet should be forwarded to stores for entry of the relevant AR No.s, quantity and assay value.

5.2.3        After the relevant entry store forward the sheet to production department where production chemist fill equipment status detail where line clearance status and ECR No. should be entered for each equipment.

5.2.4        Now operator fill the next form of process to be carried out for particular reactor in which starting and ending time should be entered and finally sign by operator and checked by in-charge.

5.2.5        After completion of every reaction in each of the particular reactor intermediate should be send to QC Lab. For checking of completion of reaction, LOD, etc.

5.2.6        After final product obtained send the request to Q.C. for complete analysis of the product and send the analytical report.

5.2.7        Fill all remaining entry and attach all analytical report.

5.2.8        BMR should be then send to Q.A. department for Review.

5.3  Review and control of batch manufacturing record (by Quality Assurance):

5.3.1        Batch no. should be checked by quality assurance department.

5.3.2        Review the analytical report of all raw materials attached with BMR and checks the A.R. No.

5.3.3        Review the equipment cleaning record for each equipment and relevance of line clearance by QC.

5.3.4        Review the deviation in process which is predefined.

5.3.5        If any deviation presents changes deviation report of process should be there. Review the report of change in deviation and its significance in the process.

5.3.6        Check the quantity of solvent recovered in the process. Recovery should be proper and complete.

5.3.7        Wet material packing record should be reviewed.

5.3.8        Drying record as well as dry material packing record should be checked and reviewed.

5.3.9        Check the analytical report of finished product generated by Q.C. department.

5.3.10    Finally attach the review report with specific number given by Q.A. department duly dated and signed by Q.A. Manager.

5.3.11    If everything is fine then pass the batch and allow it for dispatch.

5.3.12    Send this record in safe custody of Quality Assurance department.

5.3.13    If anybody needs the copy of BMR it should be given as a control copy with permission of Q.A. Manager.

5.3.14    Every BMR should be saved for five years from manufacturing and after that it should be destroyed as per SOP.

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