Master Formula And Batch MaNUFACTURING Record A SEMINAR ON Master Formula And Batch MaNUFACTURING Record

Introduction: Definition: MFR: Definition: “An approved master document that describes the full process of manufacturing for the batch of specific product.”

Definition: According to various guidelines, WHO EU Health Canada US

Different Names Of MFR: MFR (INDIA) MFPI(TGA , AUSTRALIA) MMI AND MPI (MCC IN SA) MFPI (WHO)

A MFR is required for each batch and batch size. Definition of Batch: It is single process or series of process. Definition of Lot: It is the final product in the final container.

Instructions for the preparation of MFR : Purpose Objective Scope Responsibility   

Master document include following: The name and reference code. Procedure : Master document include following:  The name and reference code. The proprietary name, generic name, strength , batch size of the product. The expected final yield. Processing instructions.

Instructions for In-process controls. Storage conditions. Packing detail. Abbreviations. Copies to Distribution Sites. 

Content of MPF (WHO): Name with reference code. Description. List of starting material. Final yield. Location. Process instruction. Storage. Precaution.

Contents of MPF (WHO): Description. Pack size. Name of the product. Description. Pack size. Complete list of packaging material. Relevant printed packaging materials & Specimens. Special precautions. Description of the packaging operation. Details of in-process controls with instructions.

Batch Processing & Control Record: Definition : B.P.C.R. is primarily a replica of the M.P.C.R., additionally it gives the actual process record of the batch produced and help in maintaining the complete production and control history of the batch.

Different Names of BPCR: BMR (INDIA) BP and BPR (WHO) BMR and BPR (MCC, SA) BP and BPR (MHRA)

BPCR are required to be maintained for each batch of product manufactured. These should be based on MFR. Method of preparation of BPCR should be such that transcription errors do not occur. Before any process begins a check should be made to ensure that all work stations are clear of previous product, material and documents. This check should be recorded.

Essential Components of a Batch Record: Document Identification. Company Name. Dates of Manufacturing. Product Identification. A step by step account of the processing and testing to be done.

The monitoring specifications-how will the operators know if the process is proceeding properly. Raw data must be collected and blanks must be filled in with the information. Materials and equipment used . Signatures required.

Batch Processing Records: A batch processing record should be kept for each batch processed. It should be based on the relevant parts. Before any processing begins, a check should be made. This check should be recorded.

Content of BPR: Name , number of the batch being manufactured. Dates and times. Name of the person responsible. Batch / lot number and the quantity of each starting material actually weighed. Relevant processing operation. Amount of product obtained. Notes on special problems.

Batch Packaging Records: A batch packaging record should be kept for each batch or part batch processed. Based on the relevant parts of the approved packaging instructions. Before any packaging operation begins, checks should be made. These checks should be recorded.

Content of BPR: Date and Time. The name of the responsible person. Name , batch number, quantity of bulk product. Date and Time. The name of the responsible person. Identity. Details of the packaging operations. Batch number, expiry date, and any additional overprinting Special problems.

Basic Difference: B/W MPCR and BPCR:- MPCR is the type of master document, means with the help of MPCR only, the BPCR is prepared. BPCR is unique batch wise, means all batches have their individual BPCR. Moreover BPCR contains ‘Date and Time’, that when the batch was processed. MPCR is the reference copy.

Example of BMR: Name of product: Alerid Tablet Batch no.: Batch size: Date of Mfg commencement: Date of Mfg Completed: Temperature: 0C Humidity: % Page No. Sr. No. Ingredient A.R. No. Quantity (Kg) Weighed by Checked by Prepared Date & Time by

Stage: Shifting or sieving Name of product: Batch no.: Date: Started on: Completed on: Time: Temp.: 0C. Humidity: %. Sr. No. Ingredient Equip-ment No. Equip-ment cleaned by Equip-ment checked by Sieve no. # Previous Product Operat-or Sign Of superv-iser

Stage: Mixing Name of product: Batch no.: Time of mixing: Mins. Temperature: 0C Humidity: % Sr. No. Ingredient Added By Checked by Equip-ment No. Equip-ment cleaned by Equip-ment checked by Previous Product Date And time

Stage : Drying Name of product: Batch no.: Temperature: 0C Date & Time : Humidity: % Equip-ment No. Previous Product Inlet Temp.(0C) Outlet Temp. (0C) Time Of Drying IPQC L.O.D. Operator Checked By

Stage: Milling Name of product: Batch no.: Practical Yield: %. Temperature: 0C Humidity: %. Equip-ment No. Previous Product Mesh Size Operator Checked By Date And Time

Stage: Lubrication Name of product: Batch no.: Temperature: 0C Humidity: %. Equip-ment No. Previous Product Time Of Blending Lubrica-nt Added Lubricant By Checked Verify Date And

Stage: Compression Name of product: Batch no.: Temperature: 0C Humidity: %. Equip-ment No. Equip-ment cleaned by Equip-ment checked by Previous Product Speed Of Machine Weighed By Checked Date And Time

Stage: Coating Name of product: Batch no.: Temperature: 0C Humidity: %. Sr. No Ingredient Equip-ment No. Previous Product Quantity A.R No. Weighed By Checked Date And Time

Stage: Packaging Name of product: Batch no.: Temperature: 0C Humidity: %. Date Of Packaging Equip-ment No. Equip-ment cleaned by Equipment checked by Line Clearance Checked By And Time

Stage: Storage Name of product: Batch no.: Date of completion: Mfg date: Exp date: Temperature: 0C Humidity: %.

MF and corresponding Batch Records: MF give the complete production instructions. Blank spaces are provided for the entry of data. The BPR is the approved copy of the master document with filled in data entries. Once a final product has been produced, BR is comprised of a single document. The product is a pool of several intermediates or final bulks then the full batch record includes the individual batch records of all the components.

Issuing of MF copy as a blank BR: MF are almost invariably stored on the computer. QA is responsible to generate a copy. The MF should make reference to in process tests, QC tests. The batch record, however, includes the record sheets of all the production records and support records.

Master formulae, once approved and signed, should remain under the control of QA. Master copies of the MF can be distributed to relevant departments if needed. There will obviously be company-by-company differences in the details of the procedures for QA approval and issuing of MF.

Electronic MF and BR: The MF is invariably on the computer, and should be under pass-word control of QA. Photocopies – stamped, numbered, and on a distribution list - may be issued as reference copies to the relevant department head. The electronic version may have the signature and date fields typed in, e.g. "official copy signed by XXX”; “official copy dated ddmmyy”. If the electronic copy is printed out as the BBR for each production run, the QA department must stamp each page of the printout and sign that it is the approved current MF.

References :- www.who.in www.law.justia.com www.ncbi.com www.law.cornell.edu www.cgmp.com www.qualityassurancepharma.blogspot.com Prof. Manohar A.Potdar,“Pharmaceutical Quality Assurance,”by Nirali Prakashan Page no.7.7-7.14

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