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FDA 21 CFR Compliance as a Gateway to Market Viability

January 27th, 2014 by James Francum

FDA 21 CFR RegulationBefore selling their products, firms have to ensure that they adhere to US and European government regulations. This is a job in and of itself; staff at all levels must maintain extensive conversance with a huge body of rules devised by the Food and Drug Administration (FDA) and other regulatory bodies.

For specialized companies trying to stay legal, such a herculean task is practically impossible without outside assistance, when one considers the restrictions that today’s companies have concerning human resources.

The Wide Scope of FDA 21 CFR

Title 21 of the FDA's Code of Federal Regulations (CFR) applies to a huge range of consumer and industrial products. For example, the title deals with all aspects of any packaging used to store food and food ingredients and includes rules about the design, manufacture, installation and storage of pharmaceuticals and medical devices. It devotes entire sections to a host of specific subjects, like the protection of human subjects in clinical trials, pharmaceutical advertising rules and even electronic record-keeping standards.

Naturally, FDA 21 CFR is very extensive, including almost 1,500 subdivided parts in numerous chapters. Code changes occur on a regular basis that most firms lack the resources to keep track of them all on their own. In the past it has often been the case that companies that try may be penalized after they miss critical sections that they weren't even aware they were supposed to be following.

Similarities and anomalies exist for the European Regulatory Agencies, which are often more complicated due to the fact that practically every European country has it’s own regulatory authority.

What Does Compliance Entail?

The breadth of FDA 21 CFR means that compliance isn't just about ensuring one's consumable products include the proper nutrition labels or packaging materials. The entire production process must be closely monitored and audited to avoid fines.

For instance, rules outlined in Title 21, Part 11, Subpart B stipulate specific standards for electronic and handwritten signatures. Those who employ these mechanisms during their quality control and validation processes must take special precautions to ensure that signatures cannot be used to falsify records. There are so many specific laws that it's impossible to comply without addressing every detail of the production process.

Following the Rules

Unfortunately, the FDA CFR doesn't lay down accepted guidelines on how to comply. Instead, rules read like long lists of requirements that simply have to be followed.

It's essential to work with consultants that possess the legal background and experience to validate the manner in which firms operate. By bridging the gap between quality assurance, legal and IT departments within firms, these consultants ensure that compliance doesn't obstruct otherwise viable market endeavors.

GxP-CC provides a one-team approach to assist companies in the pharmaceutical, medical devices and dental lab industries with compliance issues. Contact them today to discuss your needs in becoming compliant across the lifecycle of your product.






Posted in Compliance Consultants, European Medical Device Directive, FDA 21 CFRs, FDA & European Regulations, GxP CC, ISO 13485, Medical Device Compliance, Part 11, Pharmaceuticals

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James Francum

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