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Good Manufacturing Practices Q&A

  •   Is there a base page that we can get various cGMPs to do on a quarterly basis, yearly, or monthly?

    Answered September 1st, 2010 by Expert: Mollie Kober

    As companies become more familiar with the requirements, current Good Manufacturing Practices (cGMPs) should be part of everyday business. cGMPs are ever-evolving, and one way companies can stay abreast of what is going on in the industry is to be part of a third-party auditing program such as NSF. Some companies try to break the regulations apart based on their subparts. However, I don’t think this is the best approach because some items need concentration daily, while others only once a year or maybe once a period.

    I’ll try to address your question by giving you some best practices that I’ve witnessed. An annual systems audit, which addresses different parts of the regulations, is a good approach. The audit may include sampling a number of production lots and reviewing testing and manufacturing records, sampling a group of employees, and assessing the level of training or trending complaints and product returns. Annually, Standard Operating Proceduers (SOPs) could be reviewed for accuracy. Tasks that may be completed quarterly or monthly may include audits of sanitation, housekeeping, and employee compliance to SOPs.

    Another good practice is to develop an ongoing training program that tackles different monthly topics related to product safety, refresher training on certain SOPs, industry awareness, chemical handling, HACCP if applicable, etc.  As a set part of the training meeting agenda, companies choose to go over any customer complaints or product safety incidents from the previous month, review previous audit findings (from a third-party or housekeeping audit), and complete training on changes to documents, equipment, or facilities.

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