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Are You Ready for a GMP Inspection?


by Kim Weeks, Ronald Rhodes and John Davidson

In today’s dietary supplement world, manufacturers and marketers are ultimately responsible for the authenticity and safety of the supplements they release to consumers. FDA established cGMPs (current good manufacturing practices) to meet certain standards and will conduct visits, planned or unplanned, to check on compliance. Failure to comply can result in shutdowns, recalls or worse. 

Self-audit questionnaires can be helpful as the can focus on all sections of 21 CFR 11 and help organizations recognize, in order to succeed, they need to create dedicated quality management systems run by professional quality assurance (QA) managers. Investing in full-time experts, specialists who understand the “c" in cGMP stands for “current," is the best way to ensure organizations stay up to speed on regulations.

Well before an FDA examination, companies should hire a QA manager and establish an internal audit program. This self-policing system ensures the company follows cGMP requirements at every step within its quality management system. It is a checklist set up by the QA manager, performed on a regular schedule, to help identify what works and what needs to be fixed.

The internal audit checklist should cover safety, cleanliness and design of personnel programs, physical plant, grounds, equipment and utensils. It should establish production and process control systems for quality control (QC) of laboratories, manufacturing operations, packaging, labeling, product returns, product complaints, manufacturing records, batch production records, product storage and product distribution. 

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