SOP on Review of Batch Manufacturing Record
Objective : To lay down a procedure for review of Batch Manufacturing Record.
Scope : This Standard Operating Procedure is applicable to Baddi formulation plant.
Responsibility : Officer /Executive – IPQA shall be responsible for reviewing Batch Manufacturing Record including verification of every step recorded in it, right from beginning to final authorization of BMR by Head – QA or his/her designee.
Head – QA shall be responsible for the implementation and compliance to this procedure.
Abbreviations and Definitions
BMR :Batch Manufacturing Record; is a filled /unfilled regulated photocopy of Technical Directions along with other requisite forms and records, which reveals all the information of a batch of a product.
Procedure : Officer /Executive – IPQA shall review the BMR after every step carried out.
IPQA personnel shall ensure during the whole cycle of manufacturing that respective SOPs are being followed and in-process checks are being performed and correctly recorded in the relevant formats or designated space in the BMR.
In process checks by IPQA personnel shall be performed as per SOP titled “In-process Checks by IPQA” .
Officer /Executive – IPQA shall review the process under the following headings and shall fill the relevant format himself/herself as prescribed.
Raw /Packaging Material Dispensing
Check the vendor status of the material being dispensed. Only designated /approved vendor material shall be used as per FEFO (First-Expiry-First-Out) basis and dispensed material has been approved by QC.
Check the potency calculation for active raw materials done in the BMR and check whether dispensing has been done as per potency calculation and check the quantity of the materials, which shall adjust the standard batch weight.
Check the entries of raw materials (randomly) with relevant Stores dispensing documents as well as documents like weighment tags are attached in the BMR.
Verify the compliance of the concerned SOPs followed during dispensing.
Manufacturing /Packaging Operations
Ensure and confirm with remarks and signatures (where applicable) that each manufacturing operation is correctly carried out and recorded as defined in respective manufacturing /packaging instruction.
Check the time of operation and other entries are signed and dated by the person performing and supervising the activity. Till then next operation shall not start.
In-process parameters like weight /fill variation, average weight, thickness, diameter, hardness, deliverable volume etc. shall be verified and recorded by IPQA personnel too, wherever applicable.
Ensure the accuracy of packaging materials used.
Check the printing and/or over coding /stencil on the inner cover of the BMR to verify that correct information is available on them.
Ensure the compliance of respective SOPs followed during manufacturing and packaging operation.
Test Reports
Verify that the test results are in accordance with the prevailing specifications of the product /in-process materials and last reports /COAs are attached with BMR before proceeding to next step.
Ensure test Reports /COAs are signed by the chemist who has performed the test and Head – QC, as an authorization for next operation.
Miscellaneous Checks
Confirm in-process checks are being performed as per respective SOPs and recorded with correct calculations.
Ensure yield is being calculated and recorded at indicated steps in the BMR.
Review and confirm the reconciliation of packaging materials vis-à-vis to the quantities of destruction note and material return note (if applicable).
Ensure that Certificate of Analysis for active raw materials /finished product is attached and is within specified limits of respective tests.
Ensure Expiry Date is assigned to the product as per SOP titled “Assigning of Manufacturing and Expiry Date to the Finished Products during Manufacturing”.
Confirm whether the recording related to the retail price of the product, if applicable and batch coding /overprinting details, any special coding by customer, if required is adequate and correct and check whether the specimen of relevant packaging materials are attached.
After compilation of entire process of manufacturing, and packaging, BMR shall be forwarded to Head – QC or his/her designee for his/her approved in Certificate of Release (refer SOP titled “Release of Finished Goods”).
After receiving the filled BMR from QC department duly signed by Head-QC on the Certificate of Release, IPQA shall forward the same to QA department for final Review.
Officer / Executive QA shall review the BMR and Quality Control Reports as per the Checklist for BMR review .After final review of BMR ,BMR review process shall be compiled by officer / Executive –IPQA.
Head – QA or his/her designee shall approve the Certificate of Release (refer SOP titled ‘Release of Finished Goods’.
Note: The scope of review of BMR shall not be restricted to the points given in the SOP /Checklist only. BMR shall be reviewed for its total integrity w. r .t. to recording against various steps and activities performed during the manufacturing of the product.