05.3.2016 Jeff Thomas

    GMP Training - Are you watching it as closely as FDA is?

    Pharmaceutical firms cannot have any errors in the manufacturing process.  One process or supply error can contaminate an entire production cycle. At the same time, the government has strict standards on the manufacturing process that must be followed.  Violating these can result in fines or production halts. binoculars.jpgTo avoid these issues, companies create Good Manufacturing Practices (GMP) and put in place stringent training. GMP training is important to the FDA and helps the company achieve a high level of performance and quality.

    In fact, companies must be aware of stepped up actions by the FDA to protect consumers. The FDA questions the training and production of chemical products by employees at every step in the process. For example, the FDA recently warned a cosmetics company because a single chemist in its R&D facility did not have the necessary training on microbial limits to prevent critical errors. The FDA continues to issue more and more warning letters on training and will not hesitate to impose penalties to companies that do not comply.

    To avoid these problems, companies must have a detailed training and compliance process. Firstly, they must use top of the line education that provides all of the most up to date information. Finding this education is not easy but there are a number of providers with solid baselines. You may need to customize for your organization. Secondly, they need rock-solid procedures to follow that ensure high quality production and FDA compliance. 

    Perhaps just as important as the training is the documentation of the entire process. Companies need detailed, online records of exactly who was trained on which topics during what time period. Those detailed records are the best defense a company can offer an FDA auditor in the case of an error. 

    Companies are still struggling to comply with the regulations and requirements even though they are fairly clear. According to a recent article, J&J's McNeil division is struggling to educate its workforce and control the quality of its products. This was exacerbated with the company purchased Pfizer's consumer products divisions and cheaply set-up shop in a location which had a string of errors.

    More than anything, companies need for their management to buy-in on the compliance process. The best technology and training in the world won't do anything if the management is not committed to getting employees trained and tracking that training. Although it creates extra work and effort, there is no substitution for focus on the issue.

    Unfortunately, a large contingent of the compliance industry is near retirement as well. Managers can pick-up these skills but a dedicated workforce is also required. Still, a good management system can help with the effects of retiring workers. These systems track training and provide automatic follow-up with employees that have not completed their assigned tasks. The system can serve tailored education to specific employees, groups or teams and then monitor the results of any quiz they take. Further, the results can be prepared in an easy to read format for senior managers to digest. At the end of every month, quarter or year, managers can check-up on the status of training. If there are any deficiencies, they can push the direct employees to complete their necessary task.

    ZenQMS is one of leading providers of electronic Quality Management Systems (eQMS). The firm's platform helps companies implement and track the compliance and education that the FDA demands. With the system, companies are sure to have their compliance process in order for the cases of FDA audit or action. ZenQMS has a unique model with no individual seat licenses so organizations can maximize their training. For more information, please contact us.

    Published by Jeff Thomas May 3, 2016
    Jeff Thomas