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How Compliant Are You with 21 CFR 210 / 211?

April 23rd, 2015 by

Pharmaceutical ManufacturingYou know which rules you’re responsible for following, but is that enough? Agencies like the FDA rarely make exceptions for firms that misinterpret the law, and although you may be able to keep a non-compliant product on the market with some quick thinking now, you won’t always get so lucky. Knowing your way around 21 CFR 210 and other major regulations is key to creating a quality management system that actually does its job proactively.

Familiarizing Yourself with 21 CFR 210

Although it’s only one of many subsections contained in Title 21, 21 CFR 210 lays down some important rules for those who participate in the pharmaceutical industry. Essentially 21 CFR 210 describes and defines the status of the cGMPs and the applicability of those regulations to pharmaceutical manufacturers.

Along with other parts of 21 CFR, such as 211 through 226, 210 defines the good manufacturing practices you need to follow when producing pharmaceuticals. These titles also establish the authority of the regulations they include by mandating that non-compliant firms be subjected to various regulatory consequences. Though some other regulations merely contain guidelines or suggestions, these rules can notably impact your products’ marketability.

Also bear in mind that 21 CFR 200 series of regulations aren’t just for manufacturers either. Because the rules explicitly address handling, storage, labeling, processing, donor selection and a host of other elements common to the pharmaceutical marketing process, they impact a number of key industry players.

Firms that want to sell their products in FDA-regulated markets must be willing to apply stringent compliance-assurance efforts to every part of their supply, manufacturing and distribution chains.

Actually Following the Regulations

For some, 21 CFR compliance improvements can be easily achieved through the implementation of supplier audits and similar mechanisms. Other organizations, however, must create complete compliance systems. While it’s rare for a modern manufacturer to lack compliance mechanisms entirely, companies that haven’t previously focused on FDA regulatory practices may find their existing implementations vastly insufficient.

In some cases, firms get clues about where to start improving their compliance efforts by assessing their past regulatory encounters. For instance, if your organization recently received a Form 483 letter, it should serve as an obvious indicator that your compliance system requires radical alteration and adjustment in the specific areas cited in the 483. Nonetheless, it remains important to assess 21 CFR 200 series regulations for each individual problem or compliance gap.

Identifying Weaknesses

Of course, the problems your company will face when addressing non-compliance issues cited in a FDA Form 483 will usually not have an easy solution. To attain a suitable solution will usually involve intensive work and thought. This can present a major dilemma for extensive compliance systems or operations. How do you start improving when you don’t know what your deficiencies are?

Take charge of your 21 CFR 210 / 211 compliance struggle. Working with consultants who understand how the best compliance systems are structured helps you reassess your own quality management practices from a more insightful perspective.

Contact GxP-CC to learn more about what 21 CFR 210 / 211 compliance ultimately entails for your organization.

 

 

About this author:

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Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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