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Master Formula Records

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. 

The Master Formula shall include: -
  • The name of the product together with product reference code relating to its specifications;
  • The patent or proprietary name of the product along with the generic name, a description of the dosage form, strength, composition of the product and batch size;
  • 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 course of processing.
  • A statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable.
  • A statement of the processing location and the principal equipment to be used.
  • The methods, or reference to the methods, to be used for preparing the critical equipments including cleaning, assembling, calibrating, sterilizing;
  • Detailed step wise processing instructions and the time taken for each step; 
  • The instructions for in-process control with their limits;
  • The requirements for storage conditions of the products, including the container, labelling and special storage conditions where applicable;
  • Any special precautions to be observed; 
  • Packing details and specimen labels.
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