Get Kaliakoir Hitech Park 100-150 Mw-ipp Implementation Agreem

MASTER FORMULA RECORD  Master Formula Record (MFR) is a master document for any pharmaceutical product.  MFR contains all information about the manufacturing process for the product.  MFR is prepared by the research and development team of the company.

Pharmacists are required to document the following information in a master formulation record when compounding a drug using either sterile or non-sterile techniques: Name, dosage, and strength of the drug. Calculations used. Ingredients and quantities. Equipment used. Step-by-step instructions of how the drug was compounded.

SUMMARY OF CONTENT Description of ingredients, their quantities and sources (e.g., physical description, DIN, manufacturer, etc.) Quality control procedures and expected results (e.g., weight range of filled capsules, pH of aqueous liquids, etc.) Mixing instructions and methods, which may include: order of mixing.

A Master Formulation Record should be created before compounding a preparation for the first time. This record shall be followed each time that preparation is made. In addition, a Compounding Record should be completed each time a preparation is compounded.

The Master Formula Record should include: the name of the product, with a product reference code relating to its specification; a description of the dosage form, strength of the product. batch size. Shelf Life. Storage Condition.

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.

It guides and records the formulations and techniques on the production line to manufacture a specific batch of products. So, apart from providing guidance, the batch record also offers proof that a particular product batch was manufactured ing to the procedures detailed in the master formula record.

The Master Formula is a method developed to be used for virtually any drug or intravenous calculation. It is easy to learn, and simple to use. It has been used in the classroom for over 20 years with overwhelmingly positive support.

The MFR serves as a master document and is used as a reference for creating batch-specific documents, such as Batch Formula Records (BFRs), which contain specific instructions and records for each manufacturing batch.