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226.102 Master-formula and batch-production records. The record shall include: (1) The name of the Type A medicated article(s) and a specimen copy of its label. (2) The weight or measure of each ingredient, adequately identified, to be used in manufacturing a stated weight of the Type A medicated article(s).
The required elements are: (1) Active ingredients to be used. (2) Equipment to be used. (3) The maximum allowable beyond-use date for the preparation, and the rationale or reference source justifying its determination.
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 Formulation Record (MFR) shall contain the following information: The name, strength and dosage form of the preparation. Calculations required to determine and verify quantities of components and doses of active pharmaceutical ingredients. Description of all ingredients and their quantities.
A master formula record (MFR) is a document that includes all of the details about a pharmaceutical product. The MFR contains all information about the manufacturing process of the product. The MFR is prepared by the companys research and development staff.
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Master Formula Record (MFR) is a master document for any pharmaceutical product. MFR contains all information about the manufacturing process for the product.

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