SOP for Issue, Entry, Review and Control of Batch Manufacturing Records

Purpose

To detail the procedure for issue, entry, review, release, and control of Batch Manufacturing Records.

Objective

To provide a documented procedure for issue, entry, review, release, and control of Batch Manufacturing Records by QA.

Scope

Applicable while issuing, entering, reviewing, releasing, and control of Batch Manufacturing Records.

Responsibility

Primary: Officer–QA / Officer–QC/ Officer-Production

Secondary: Manager-QA/ Manager- QC/ Manager- Production 

Procedure

Issue of batch manufacturing record ( by Quality Assurance)

• Based on Production planning, the production manager shall decide on the product and the number of batches to be produced in the month.
• The production supervisor shall raise the requisition for the batches to be taken for the week and forward it to Quality Assurance.
• On receipt of Batch Manufacturing Record issue requisition QA personnel will verify the details entered in the requisition form.

• A photocopy of the MASTER COPY of the required Product Batch Manufacturing Record will be taken.
• All the pages of the photocopied sheet of the Product Batch Manufacturing Record shall be signed and dated by QA Personnel.
• Check for the correctness of the Batch number by verifying the BMR register.
• Enter the details of Date, Product, Batch No, Batch size, Manufacturing Date, Expiry Date, and issued by details in the BMR register.
• Check and allot expiry date by referring to the master list of product shelf life.
• If there is a deviation for change in batch size or any other equipment/process change raise the deviation approval form as per deviation procedure SOP.
• Enter the Batch No. on all the pages of the BMR and get it authorized by the QA Manager or in the absence of the QA Executive or QA Officer.
• Insert the signed Batch record in a BMR cover and enter the details of the product name, Batch Number, and Batch size. Manufacturing date and Expiry date.
• The 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 the batch record.
• QA person who has issued a Batch Record shall sign the “issued by” on the batch record issue requisition sheet and file the same for future reference.

ALSO READ: SOP for Document Control, Issuance and Numbering System

Entry of Batch Manufacturing Records (By Production Personnel)

• On receipt of BMR Production Manager / Dy. The production Manager shall check the BMR and sign on the first page.
• The calculation sheet should be forwarded to stores for entry of the relevant AR Nos., quantity, and assay value.

• After the relevant entry store forward the sheet to the production department where the production chemist fill in the equipment status detail where line clearance status and ECR No. should be entered for each piece of equipment.
• Now operator fills in the next form of process to be carried out for a particular reactor in which starting and ending times should be entered and finally signed by the operator and checked by the in charge.
• After completion of every reaction in each of the particular reactor intermediate should be sent to QC Lab. for checking of completion of the reaction, LOD, etc.
• After the final product is obtained send the request to QC for a complete analysis of the product and send the analytical report.
• Fill in all remaining entries and attach all analytical reports.
• BMR should be then sent to the QA department for Review.

Review and control of batch manufacturing records (by Quality Assurance)

• Batch No. should be checked by the Quality assurance department.
• Review the Analytical report of all raw materials attached with BMR and check the A.R. No.
• Review the Equipment Cleaning Record for each piece of equipment and the relevance of line clearance by QC.
• Review the deviation in the process which is predefined.
• If any deviation presents a change deviation report of the process should be there. Review the report of change in deviation and its significance in the process.
• Check the quantity of solvent recovered in the process. Recovery should be proper and complete.
• Wet material packing records should be reviewed.

• The drying record as well as the dry material packing record should be checked and reviewed.
• Check the Analytical report of the finished product generated by the QC Department.
• Finally, attach the review report with the specific number given by the QA department duly dated and signed by the QA manager. 
• If everything is fine then pass the batch and allow it for dispatch.
• Send this record in the safe custody of the Quality Assurance department.
• If anybody needs a copy of BMR it should be given as a control copy with permission of the QA Manager.
• Every BMR should be saved for five years from manufacturing and after that, it should be destroyed as per SOP.

Abbreviation 

SOP: Standard Operating Procedure 

QA: Quality Assurance 

QC: Quality Control

BMR: Batch Manufacturing Record

LOD: Loss On Drying

Annexure

Nil

Revision History

Nil

ALSO READ: SOP for Batch Numbering System