Bulk Pharmaceutical Manufacturing Key Terms

Learn the meanings of bulk pharmaceutical manufacturing key terms

Bulk pharmaceutical manufacturing is one of the most important parts of any pharmaceutical sales company. If your research has developed a new drug that has received Food and Drug Administration approval, the only to create it in large quantities, without buying the equipment yourself, is to use a bulk pharmaceutical manufacturer. When you are browsing manufacturer's websites you may come across some terms you are not aware of. Reviewing these terms will help you know exactly how the manufacturer works.

 

Clean room

A clean room is a enclosed room that is completely controlled. Clean rooms protect against pollutants, airborne particulates and other contaminants. Clean rooms are temperature controlled and are free of bacteria, viruses and pathogens.
Try: TechTarget has a more detailed description of clean rooms. Merriam-Webster Online Dictionary also has more information about clean rooms available online.

CMC

Chemistry, Manufacturing, and Controls or CMC means that at least part of pharmaceutical development is shown to be in control and proceeding properly. This normally refers to the way the substance is made.
Try: UC Irvine Extension has more information about CMC. Pharmaceutical Product Development also has more information about Chemistry, Manufacturing, and Controls.

HACCP

HACCP or Hazard Analysis and Critical Control Points is a plan that all manufacturers of foods and drugs must have. The HACCP is a plan that reviews the manufacturing process to locate points in the process that could cause contamination.
Try: Visit the International HACCP Alliance for a detailed description of what  HACCP entails.

cGMP

cGMP stands for current good manufacturing practice. cGMP is a set of rules and regulations put into place by the U.S. Food and Drug Administration. These laws are to ensure that products are tested, pure and effective.
Try: Read more information about current good manufacturing practice at PERI. What-is.Net also has more on cGMP.

DMF

A DMF is a drug master file. This is a file that contains all the ingredients in a drug, all tests run on the drug and any known side effects. The DMF also provides the purity levels of the drug and the cGMP of the manufacturer. This file is submitted to the FDA and all files are searchable online.
Try: Find regulations and full information about the drug master file at the U.S. Food and Drug Administration. Search through drug master files at USActives.

cGLP

cGLP or Current Good Laboratory Practices is another set of rules and regulations set by the U.S. Food and Drug Administration. These regulations cover the testing process of drugs.
Try: Visit The Center for Professional Innovation and Education for more details on cGLP. ComplianceOnline.com also has information on regulation for cGLP.

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