Good Manufacturing Practice (GMP) Violations and Risky Recalls

Good Manufacturing Practice (GMP) Violations and Risky Recalls

Recently, several dietary supplement products have been recalled because of Good Manufacturing Practice (GMP) violations. GMP are part of the quality assurance process that ensures products are safe to use and are of quality. We’ve written about the importance of having a traceability program in the past–and it’s still just as crucial to have a program in place that is compliant with the new Safe Food for Canadians Regulations (SFCR).

Source’s Food Safety Team recommends that each Contract Manufacturing Organization (CMO, or supplier) undertakes an annual current Good Manufacturing Practice (cGMP) audit.  This annual audit would include a formal cGMP site inspection and a review of current Standard Operating Procedures (SOPs) and training logs. Manufacturing practices which are not in adequate control present the possibility of risk being introduced into the manufacturing process, which can result in quality issues in finished supplement products (i.e. identity, purity, strength and composition).

 Some common GMP violations include:
  • Inadequate identification (i.e. analytical verification) of incoming ingredients
  • Lack of set Master Manufacturing Records (MMRs)
  • Ineffective finished product testing
  • Failure to implement and follow written procedures
  • Failure to set limits on contaminants

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Sign up for our Whitepaper: Recalls are Big Business: With Negative Implications.

Recalls can cost a hefty amount, but a damaged reputation can result in short earnings in the long run.

Don’t fret! Working with a  contract research organization that specializes in food safety and labelling compliance will ensure your packaging is safe to hit the shelves. We have a very experienced and knowledgeable team that can help you develop a food safety plan that is compliant and safe. Reach out to us today so that you can feel confident in the integrity of your supply chain, and focus on making your product shine on the shelves!

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