BMR Preparation and Control SOP

1.0 OBJECTIVE

To lay down a procedure for preparation and control of Batch Manufacturing Records.

2.0 SCOPE

This procedure is applicable for preparation and control of batch manufacturing records present in the XXX, Place.

3.0 RESPONSIBILITY

3.1 Preparation: Sr. Executive-production

3.2 Checked by: Head-Production

3.3 Approved by: Head-Quality Assurance

4.0 PROCEDURE

4.1 Preparation of BMR

4.2 The BMR Consists of the Following items

4.2.1 The header consists of Name of the Product, generic name, Batch No, Batch size, MFR No, BMR No, Effective Date, and Review Date and along with Page numbers in XX of YY format.

4.2.2 Next to header table consists of Issuance of Batch manufacturing record details such as BMR Issue Number and QA sign and Date.

4.2.3 Summary Consists of S.No, Process Stage, Date Started, Date Completed and Remarks.

4.2.4 Product profile Consists of Product Name, Dosage form, pack size, label claim, Storage conditions, shelf life and mode of sale.

4.2.5 At the end of the first page the table consists of Signatures and date of prepared by, checked by and approved by columns.

4.2.6 The BMR preparations shall be done by Production Executive, checked by Head-Production and Approved by Head-Quality Assurance.

4.2.7 The format is given in the Annexure-1

4.2.8 The font used for BMR Preparation is Verdana for dry powder injections and calibri for other BMRs.

4.2.9 The total process is to be described in a written procedure with a well trained person and such written procedure shall be dated and signed by competent technical staff and independently checked, finally approved by QA authority.

4.2.10 A complete list of all the ingredients to be used in the manufacture of the product indicating any special quality characteristics given in the BMR.

4.2.11 An accurate statement of weight/measure of each ingredient (same weight system should be used) required as per formula of dosage form and the weight/measure actually to be used (e.g. overages to compensates losses during storage).

4.2.12 A statement of theoretical yield including permissible limits beyond which investigation is required.

4.2.13 The total manufacturing process is described in various steps in order of sequence along with the in-process QA activity.

4.2.14 The in-process check records are maintained and duly signed by the Production and in-process QA personnel.

4.2.15 Process control to be exercised by QA during processing and final packaging.

4.2.16 Precautions to be taken during manufacture and storage of semi-finished product.

4.2.17 The reconciliation of packing materials and the yield reconciliation carried out separately.

4.2.18 It is very important to describe the quantity of Recoverable Residues are added to the running batch in reconciliation process along with Quantity of Recoverable Residues added.

4.2.19 Complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations and precautions to be followed.

4.2.20 Finally the processed BMR has to be checked by the production manager along with the all attachments like Dispensing labels, equipment rinse water analysis reports, In-process and Finished COA’s, packing material specifications and FGTN etc...

4.2.21 After completion of finished analysis the QA-Head should rechecked all the BMR contents and finally he has to Released/Rejected the Batch.

4.2.22 If there is any problem in processed batch – the production-head has to arise the deviation note of that particular batch in the presence of Head-QA.

4.3 Issue of Batch Manufacturing Records

4.3.1 Production Department shall intimate the requirement of Batch Processing and Packaging record through a request form as per Annexure-2 to QA.

4.3.2 The Batch No. shall be entered in each page by Executive – QA or above.

4.3.3 QA shall print required number BMRs.

4.3.4 QA shall stamp the batch manufacturing record by issued by date along sign stamp which is blue color.

4.3.5 Then QA-Executive shall write the BMR control Record given in Annexure-3. The Record Contains issue No, Date, Name of the Product, batch No, Batch size, Mfg Date, Exp Date, Requested by (Production), Issued by (QA), Date of Return, Returned by (Production) and Received by(QA).

4.4 Movement of BMRs

4.4.1 Production personnel shall receive the BMR from QA and forward to Stores Department.

4.4.2 Stores department shall dispense the Raw Material/ Packing Material and enter the details of issuance and sign on the BMR, which is counter checked and signed by QA personnel. The details like Quantity issued and Analytical Report Number are entered in the BMR, which will be checked and signed by QA in Checked by column.

4.4.3 The Batch manufacturing records shall be maintained by the production department till all the manufacturing / packing stages are completed.

4.4.4 Relevant entries shall be made by Production department in the BMR.

4.5 Instructions, concurrent with process during each stage of manufacturing / packing shall be counter signed by IPQA personnel wherever applicable.

4.5.1 BMR shall be checked for completion and correctness and signed by Production personnel at the time of batch completion.

4.5.2 Completed BMR shall be counter checked and signed by the Production Head or his designee and shall be forwarded to QA.

4.5.3 Completed BMR from Production shall be cross checked by the QA personnel as per SOP No: IGPL/QA/GEN/033, and returned back to Production department if any discrepancies are observed.

4.5.4 Production department shall forward the completed BMR to QA after correction as per the observations made by QA.

4.5.5 QA personnel shall counter check the corrected BMR and forward to Head-QA for final signature.

4.6 Cancellation of Issued BMRs

4.6.1 Unexecuted BMR shall be returned to QA specifying the reason.

4.6.2 QA shall destroy the unexecuted returned BMR and shall enter the details in the issuance register.

4.7 Storage of Completed BMRs

4.7.1 The completed BMRs shall be stored in the Documentation Room.

4.7.2 Every BMR shall be retained for one year after the expiry date.

4.8 List of documents with BMR

4.8.1 In-process Labels

4.8.2 Cleaned Labels

4.8.3 Finished goods transfer note.