Good Manufacturing Practices, or GMP’s, are essential to the success of laboratories, manufacturers, packagers and distributors, among others. Issued by the US Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act, GMP’s provide a framework for manufacturing best practices. They help define general quality measures for both production and quality control to ensure all processes necessary for production and testing are clearly defined, reviewed and documented. These regulations require a quality approach to manufacturing, encouraging companies to minimize or terminate instances of contamination by addressing issues such as:

• Sanitation
• Cleanliness
• Personnel qualifications
• Equipment Verification
• Compliant Handling
• Process Validation

For most manufacturers, personnel are paramount to proactively maintaining compliant GMP regulations. The FDA clean room regulations require strict environmental controls that begin with the initial planning and construction of the clean room. GMP regulations are enforced by trained inspectors who evaluate a company’s facilities and processing procedures. If a company is not meeting GMP regulations, it can result in an investigation that could lead to a bumpy road of product recalls and costly fixes. If your company anticipates a future inspection, some things to take note of in your facility are:

• Prevention of cross-contamination
• Hygiene of all manufacturing areas
• Clearly written and defined manufacturing processes with instructions
• Full training of all employees
• Sourcing of quality raw materials
• Up-to-date records of manufacturing batches, distribution and complaints

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