A Master Formula Record is defined as an approved master document, with instructions of how the entire manufacturing process must be performed for each batch size of each product to be manufactured. This document ensures that there is uniformity across batches of the same product. The Master Formula Record must be prepared, signed, and dated by one competent individual, and independently checked, signed, and dated by another competent person in the quality department. All processing of a given batch must proceed as per its MFR.
Contents of Master Formula Record:
- Name of product, its strength, and dosage form description.
- Name and measure/weight of each active ingredient per dosage unit or unit weight or measure of the drug product.
- Statement of total weight or measure of a dosage unit.
- List of component names and their weight or measure using the same weight system.
- Statement of theoretical weight or measure where necessary in the processing phase.
- Statement of theoretical yield with minimum and maximum percentage of yield acceptable beyond which there must be an investigation of the process.
- Description of containers, closures, and packaging materials to be used for the drug product packing.
- Specimen or copy of each label/labeling material with the date and signature of the authorized person who has approved the labeling.
- All manufacturing and control instructions in detail.
- Procedures for sampling and testing.
- Specifications for raw materials, intermediates, and finished products.
- Instructions for storage of intermediates and finished products.
- Special notations and precautions to be observed.
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