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Preparing A Superior Audit Checklist With FDA 21 CFR 210

May 27th, 2014 by

21 CFR 210 Compliance Road MapIt’s hard to navigate in the dark, and although FDA regulations can seem blindingly overwhelming, smart pharmaceutical manufacturers actually use them to clarify their responsibilities. Documents like Title 21, Code of Federal Regulations (CFR) Part 210 contain a number of guidelines that tie the practice-specific GMP regulations found in later sections to their real world implementations.

Firms that rely on audit preparation and similar forms of quality management may find that the regulations in Part 210 play vital roles in their ability to create compliance road maps.

The Scope of Part 210

Although Part 210 touches on a range of topics, its scope is unique among Title 21 regulations in that it defines how other sections, such as Parts 211, 225, 226 and 600 through 680, interact and take precedence over each other. For instance, Part 210.2 notes that firms only need to comply with the rules pertaining to operations they’re actually engaged in instead of the totality of the regulations contained in other sections.

Such details make Part 210 essential beginning reading for any firm that wants to determine the precise scope of its responsibilities.

How Does Part 210 Help with Compliance?

Compliance consultants often use 21 CFR 210 as a starting point for planning mock audits and other critical exercises. Even though Part 210 doesn’t explicitly state marketing or packaging rules for pharmaceuticals and devices, it lets manufacturers know where to look to find the codes they need to follow. Using this part as a guideline, it’s possible to plan a comprehensive self audit checklist.

Section 210.3 also enumerates a number of important definitions for terms you’ll undoubtedly encounter elsewhere. These include many essential subjects, like batches, lots, active ingredients, gang-printed labeling and yield classifications.

In order to perform effective self-audits and implement compliance structures that actually meet target goals, it’s essential to have an understanding of the language that defines the rules you’re subject to.

Improving Future Compliance Actions

The beginning of Section 210 very explicitly defines who’s responsible for adhering to compliance regulations. For example, it addresses potential regulatory action against those who own businesses engaged in donor testing and tissue distribution well as those who process, pack or hold drugs. Although it doesn’t cover specific penalties, it leaves life sciences firms with little excuse for missing essential compliance steps.

Effective compliance is intrinsically related to your ability to assess your regulatory responsibilities as they apply to the entirety of your product manufacturing, shipping and marketing operations. By using FDA regulations like 21 CFR 210 as an initial stepping stone, you can create effective compliance schema that address more of the potential weak points in your process and reduce the likelihood that you’ll be hindered by Warning Letters or other regulatory action.

GxP-CC is a top group of compliance consultants who assist medical device, pharmaceutical and dental lab firms navigate through the regulations and guidelines set forth by the FDA and European Regulatory Authorities. Contact them to discuss your needs in gaining and maintaining compliance.

 

 

 

 

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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