Master Formula Records

Definition

“A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.”There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. These shall be prepared and endorsed by the competent technical staff i.e. head of production and quality control.

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The master Formula shall include: -

(a) the name of the product together with product reference code relating to its specifications;

(b) the patent or proprietary name of the product along with the generic name, adescription of the dosage form, strength, composition of the product and batch size;

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(c) a statement of the processing location and the principal equipment to be used.

(d) name, quantity, and reference number of all the starting materials to be used. Mention shall be made of any substance that may .disappear. in the courts of processing.

(e) a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable.

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(f) The methods, or reference to the methods, to be used for preparing the  critical  equipments  including  cleaning,  assembling,  calibrating, sterilizing.

 

(g) detailed stepwise processing instructions and the time taken for each step;

 

(h) the instructions for in-process control with their limits;

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(i) the requirements for storage conditions of the products, including the container, labelling and special storage conditions where applicable;

 

(j) any special precautions to be observed; and

 

(k) packing details and specimen labels.

GMP guidelines on master documentation

Each of the regulation or guidelines below give a list of the requirements for the contents of the MF.

• WHO: World  Health  Organization  Technical  Report  Series,  No.  908,  2003, Annex  4.  Good Manufacturing  Practices  for  Pharmaceutical  Products: Main Principles

•   EU:EUDRALEX;  Volume  4  -  Medicinal  Products  for  Human  and  Veterinary Use: Good Manufacturing Practice: Chapter 4: Documentation.

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• Pharmaceutical Inspection Convention (PIC):Pharmaceutical  Inspection Co-operation Scheme PE 009-3, 1  January 2006:Guide to Good Manufacturing Practice for Medicinal Products.  (© PIC/S January2006) 

•   Canada:  Health  Canada,  Health  Products  and  Food  Branch  Inspectorate. Good Manufacturing Practices Guidelines, 2002 Edition (Version 2). 

• USA:US Code of Federal Regulations: Chapter 21, subparts 211 and 600

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MFR:sample

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Reference:

• [SCHEDULE M][See Rules 71, 74, 76 and 78]• www.pharmaguideline.com (REQUIREMENTS OF GOOD MANUFACTURING PRACTICE)

• Pharmaceutical Inspection Co-operation Scheme PE 009-3, 1 January 2006:Guide to Good Manufacturing Practice for Medicinal Products. (© PIC/S January 2006)

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• Any Questions?

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