Your firm's pharmaceutical products aren't the only things subject to U.S. and international regulations. For decades, agencies like the FDA have also required manufacturers to adhere to a range of best practices that include management of production facilities and supply chains.
The Current Good Manufacturing Practices, or cGMPs, include a number of regulations and recommendations designed to help firms protect public safety. Learning which of these guidelines apply to your operations is one of the first steps to maintaining compliant production facilities.
Your Responsibility Doesn't Go Away with Time
The word current was very deliberately included in the cGMP initiative, as GxP-regulated firms must keep up with their obligations even if the rules change down the line. The current concept also signifies that the compliance implementations a firm employs have to be sufficiently updated to adhere to standards.
Furthermore, to add to the confusion, many of the outdated regulations remain available on the internet. For example, the majority of the guidance on 21 CFR Part 11 (Electronic Records and Electronic Signatures), which the FDA withdrew around 2003 are still available on the internet.
In short, the fact that you conform to today's rules doesn't guarantee that your organization will be compliant tomorrow. Fortunately, the FDA doesn't simply spring changes on the pharmaceutical industry overnight.
New regulations are developed over time, and compliance consultants with their ears to the ground may be able to help your firm keep pace along the way. For instance, GMPs can change as a result of formal regulation or informally following the issuance of warning letters or the release of new industry data. Using routine audits and similar stress-testing evaluations may be the easiest way to maintain operational viability.
Making Sense of Compliance
Since 2003, the FDA has published numerous documents concerning cGMPs for drugs. These include reports on effective business practices as well as implementation guidelines for task groups and a host of other guidelines.
While the wealth of information does mean that there's no shortage of freely available reference material, it's important to know where to begin. For instance, your operations may only be subject to a portion of the legislation found in 21 CFR 211. Although firms must be comprehensive in evaluating their compliance obligations, they have to be judicious in their use of resources to meet their economic goals.
The Value of Experience
Compliance consultants who have industry experience may be able to help pharmaceutical firms address cGMPs more efficiently. This is especially true given the wide berth of applicable regulations.
Consider 21 CFR 211. This regulation pertains to aspects like the organization of personnel, buildings and facilities, equipment, production and process controls, etc., but its rules aren't always specific. For example, it's stipulated that your facility must have adequate lighting in all areas, but the regulation never defines what "adequate lighting" entails or provides a minimum illumination level.
The easiest way to avoid tons of cross referencing and preclude potential warning letters may be to work with someone who has been through regulatory action in the past. Pharmaceutical firms that gain increased familiarity with the extent of their cGMP compliance requirements by seeking the advice of competent consultants might find that their interactions with the FDA proceed more smoothly.
GxP-CC is a specialized team of compliance consultants with extensive experience with regulations, guidelines and directives of the FDA and EU for the pharmaceutical, medical device and dental lab industries. Contact them today to discuss your compliance assistance needs.