Master formula record

 1.0 OBJECTIVE

To lay down a procedure for preparation and control of Master formula record. 

2.0 SCOPE

This procedure is applicable to all the MFRs for drug products manufactured at Company.

3.0 RESPONSIBILITY

3.1 Preparation : Executive-Production and Quality assurance

3.2 Review: Head-Production

3.3 Approval: Head-Quality Assurance

4.0 PROCEDURE

4.1 The MFR record must include the following.

4.1.1 The MFR consists of Product name, Generic Name, MFR No, Effective Date, Review Date, product code, market, Batch Size, M.L No and Page number in X of Y format.

4.1.2 In the middle of the of document consists document change history.

4.1.3 At the end of the first page the table consists of signatures and date of prepared by (Production and QA), checked by and approved by columns.

4.1.4 The MFR preparation shall be done by production-Executive and Quality Assurance-Executive, check by Head production and Approved by Head-Quality Assurance. 

4.1.5 The format is given in the annexure-1.

4.1.6 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 checks, finally approved  by QA authority.

4.1.7 General details of the drug product and product details of the drug product shall be given.

4.1.8 A complete list of equipment's used in the manufacturing process shall be recorded.

4.1.9 Manufacturing instructions, general manufacturing process and complete manufacturing Process shall be given. 

4.1.10 Details of primary and secondary packing materials shall be recorded. 

4.1.11 In-process and process control checks shall be given.

4.1.12 Specifications of packing and finished product shall be listed in the master formula record.

4.1.13 Overprinting details, blistering, packing and final packing details shall be given in the MFR.

4.1.14 A statement of theoretical yield at different stages including permissible limits shall be given in the MFR. 

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

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

4.1.17 Permissible yields at different stages including the maximum and minimum percentage of the critical yield beyond which investigation is required. 

4.1.18 Identification of equipment and accessories.

4.1.19 Statement on shelf life of the product and retention of control samples.

4.1.20 Measures in case of deviation: If any deviation found the same should be informed to the responsible person and necessary action should be taken as per the Deviation control SOP.

4.2  All the MFR shall be prepared by Production. The original copy after the signature shall be stamped as “MASTER COPY” and retained in QA. Photocopy of the master copy shall be taken and stamped as “CONTROLLED COPY” and distributed to relevant department through distribution sheet given in SOP on SOP.

4.3 The current MFR shall be referred for approval of batch manufacturing record before issue.

4.4 Retrieval of the obsolete MFR shall be done by QA.  The Quality assurance shall maintain and archive the original MFR with a rubber stamped “OBSOLETE COPY”.

4.5 In case MFR are required by regulatory authorities or others, photocopy the MFR and shall be given for authorities with “UNCONTROLLED COPY”.

5.0 ABBREVIATIONS

5.1 QA-Quality Assurance 

6.0 ANNEXURE

Nil

7.0  CHANGE HISTORY