SOP for the preparation of Master Formula Record Some basic explanations and instructions were given for preparing various documents required by Good Manufacturing Practice guidelines from WHO and from several regulatory authorities. GMP guidelines include the requirements for documents (individual), documentation (the systems and formats for documents), and documenting (recording) of production and control activities. Most GMP guidelines provide the same or very similar information as the principles of Good Manufacturing Practice are now international in scope. In this guidance document, the requirement for master manufacturing instructions and the requirements as given in different GMP documents, Terms for Master Formula (MF) WHO identifies manufacturing instructions as “Master Formula. Other terms used in GMP guidelines and regulations are “Manufacturing Formula”, “Master Production and Control Record”, but all mean the same thing – an approved master document that describes the full process of manufacturing for the batch of product with at least cross reference to the support operations for a batch of a specific product. Individual companies may give internal names to these documents (manufacturing instructions, monographs etc.
To establish an SOP for the preparation of Master Formula Record for the processes of manufacturing and packaging to assure a uniform formatting of Batch Production Records and that each batch of a product can be identically reproduced.
This SOP for the preparation of Master Formula Record is applicable to the preparation of Master Formula Records followed by the reproduction of Batch Production Records i.e. Batch Manufacturing Record and Batch Packaging Record.
SOP for the preparation of Master Formula Record The Head of the Product Development Department is responsible for the preparation of Master Formula Records that is followed by review by the Head of Quality Operations and then checked by the Executive Director Technical and approved by the Managing Director.
- Prior to the manufacturing of first commercial batch the Master Fromula Record is prepared. The formulation and process of manufacturing and packaging is defined on the bases of observations and the inferences of the trial batches.
- The Master Formula Record should comprise of the following parts:
Title Page of the Batch Record shows the following components;
- Name of the Product
- Product Code
- Registration Number
- Batch Record Number
- Revision Number
- Effective Date
- Number of Pages
- Date of issuance of Regular Batch Record
- Type i.e.
a. Bulk; for Batch Manufacturing Record
b. Sale; for Batch Packaging Record
c. Sample; for Batch Packaging Record
- Batch Size
- Bulk Size
- Manufacturing Date
- Expiry Date
- Product Description
- Authorization for Approval
The Page 2:
The page number 2 is for the details of Personnel Deployment.
The Page 3:
The page number 3 shows the Machine Deployment and Clearance Sheet.
The Page 4:
The page number 4 is dedicated for details of Raw Material for Batch Manufacturing Record and Packaging Material for Batch Packaging Record. Moreover the addition of any re workable material is also recorded here.
The Page 5 and onward:
The procedure for the manufacturing and packaging is covered from page 5 to onward.
The ending part of the Batch Record is comprised of following sections;
- Step wise calculation of the yield for the manufacturing and packaging processes in the respective Batch Record.
- The status and recording of Re workable recovered Material.
- Line Clearance checklists for all the stages of process.
- Batch Documentation Review Checklist.
- Font Style:
- The Batch Record should be typed in Arial Font.
- Font Size:
The font size should be 11 and may be 10 or above in an orderly fashion and be easy to check; critical steps should be highlighted.
Every SOP for the preparation of Master Formula Record is regularly reviewed and kept up to date, and revised, if required, when the Bill of Material of the respective Product is revised, or there is any change in the process of manufacturing or packaging. The revised Master Formula Record is assigned specified no. for identification and reviewed, checked and approved by designated authorities.
When a Master Formula Record has been revised, effective date of corrected version is given and previous obsolete Master Batch Record should be preserved for legal purpose.
The Master Formula Record must be stored in lock by issuing authority.
Reproduction of the Master Formula Record should be clear and legible. The reproduction of the Batch Production Records from Master Formula Record must not allow any error to be introduced throughout the reproduction process.
BATCH RPODUCTION RECORD
Batch Production Records i.e. Batch Manufacturing Record and Batch Production Record should be prepared, maintained, and controlled for each batch of product. The batch production record shall contain an accurate reproduction of the manufacturing formula, procedure, and product specifications from the correct Master Formula Record to be used in the production of a batch of a product. These batch records are then sent to each of the departments involved in the production, packaging, and control of the product.
The Batch Production Records include date, specific code or identification numbers of each ingredient employed, weights or measures of components and products in the course of processing, results of in-process and control testing, and the endorsements of the individual performing and supervising each step of the operation.
To prevent inadvertent use, the obsolete documents should be disposed off by the issuing authority. Till the time these are disposed off, they are kept separately under lock and key in the control of authorized person.