A Master Production Record (MPR)is one of the several important documents that a manufacturer of finished pharmaceuticals has to maintain and furnish. It is one of the indispensable parts of pharmaceutical good manufacturing practices (GMP’s). FDA’s regulations on Master Production Record (MPR) are found in Code of Federal Regulations (CFR)’s Title 21, Volume 4. The current standard was revised on April 1, 2012.
Emphasis on double checking
FDA’s Master Production Record (MPR) guidelines are framed with the intention of ensuring that the finished pharmaceutical products maintain the same uniformity across each batch, no matter how many batches are produced of the pharmaceutical product. The manufacturer has to maintain records for each batch and stage of production. These batches have to be prepared, checked and signed by one person designated by the organization. Another independent, second person has to cross check these and carry out the same procedures, namely prepare, check and sign of the first person.
What should the Master Production Record (MPR) contain?
The FDA has clear guidelines on what all should go into the Master Production Record (MPR). It should have these:
- The product’s name and strength as well as a description of the dosage form
- The name, weight and measure of each active ingredient
- Full list of the components that have gone into the drug
- Aprecisedescription of the weight or measure of each component using the same weight systemfor each component
- A Master Production Record (MPR) should also have a statement about the excess quantity of any of its components
- It should also have a statement of theoretical weight or measure that the drug had at different, designated phases of processing
- A description of the drug product containers
- The Master Production Record (MPR) should have allspecifications,sampling and testing procedures,manufacturing and control instructions, precautions to be followed and special notations.
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