cGMP Training: Is Your Company Following cGMP Best Practices?

The quality of manufactured goods is something that the Food and Drug Administration (FDA) takes seriously. CDER established the Quality Initiative and the Office of Pharmaceutical Quality (OPQ) for this reason.

Following Current Good Manufacturing Practices (cGMPs) is one way that pharmaceutical, biotech, and medical device companies can ensure that they are remaining compliant and following industry best practices.

But how does the FDA view cGMPs—and what areas do they focus on the most?

The FDA’s Definition of cGMPs

According to the FDA, cGMPs “provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.”

They are designed to assure that individual products are:

• Identifiable
• The right strength
• High-quality
• Pure

cGMPs were designed to be flexible to allow companies to maintain compliance using models that are appropriate for their business. It also encourages companies to innovate by leveraging modern technologies to improve the overall quality of the goods they manufacture.

How Does the FDA Handle cGMP Compliance?

Compliance is one area where many companies struggle. The FDA’s approach to cGMP compliance includes inspections of a company’s assets, whether that involves its facilities or the ingredients they use.

Inspection targets are usually determined using reports highlighting defective drugs from the public and the industry.

If a company doesn’t comply with cGMP regulations, any drug they produce is considered to be “adulterated.”

cGMP Training – An Invaluable Tool for Staying Compliant

Staying up to date on everything that’s happening in the manufacturing of pharmaceutical, biotech, and medical device products isn’t easy.

GMP training is designed to keep your knowledge of industry best practices up to date. At the Center for Professional Innovation and Education, we offer GMP training courses that can help your staff stay current. Our courses provide your staff with valuable industry insights, including:

• The basics of GMPs
• How the FDA and EU approaches cGMPs
• Department roles and functions
• The right approaches to regulatory interactions
• The types of facilities and equipment and how cGMPs affect them
• Vendors and material control
• The importance of having a suitable process control system in place
• Packaging and labeling
• Validation methods
• How to approach lab control
• Ways your company can navigate product releases and distribution
• Recordkeeping, reports, and investigations
• And more

GMP certifications are a worthwhile pursuit for any company that wants to develop a reputation for being a compliant manufacturer in the pharmaceutical, biotech, or medical device industries.

Are you interested in some of our GMP training courses? We also offer:

• Basic GMPs for the QC Laboratory
• Good Manufacturing Practices Training | GMP Course
• GMP Facility Certification Program

Do you have questions about our GMP training courses? Contact a member of the CfPIE team today by phone at 1-610-648-7550 or email at [email protected] to learn more about our various training courses.