(GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™

Obtaining certification is a straightforward process through CfPIE’s training program. We require three core courses and one elective for each certification track, which includes Good Manufacturing Practices Certified Processional (GMPCP) certification. Once you pass the examinations for each of the four courses, CfPIE will mail your certification automatically.

CfPIE also offers a GMP Facility Compliance certificate which is issued through our comprehensive auditing process. 

A facility good manufacturing practice (GMP) certification confirms via an independent audit that your organization follows FDA guidelines, practices, and prerequisites. Certification shows that all aspects of your manufacturing process are compliant, from raw materials to internal procedures.

Any potential business partner will prefer to work with GMP-compliant facilities, as they are more likely to prevent contamination and ensure strength and quality in their final products. GMP certification ensures quality at the manufacturing level rather than relying on final testing.

CfPIE’s compliance program takes 18 to 24 months on average to complete. Because GMP requirements change over time, we recommend completing the GMP certification process within 2 or 3 years, even though there is no time limit.

The “c” in cGMP (current Good Manufacturing Practice) is the crucial term since standards may change over time to reflect new findings and research.

CfPIE’s certification program requires completion of 4 courses. The costs are $2,150 per two-day course and $2,650 per three-day course, though a $200 discount per course is available if you register at least 30 days in advance or enroll multiple attendees or for multiple courses at one time.

Beyond course fees, CfPIE does not charge additional costs for certification. CfPIE certifications also do not have expiration dates, so you’re investing in long-term benefits in your career.

Compliance with good manufacturing practices begins with these 5 primary components.

• Raw materials. Quality control issues with raw materials manifest as problems in the final product, endangering the health and safety of the end user. GMP compliance starts with your suppliers.
• Facility control. Equipment on the factory floor must receive regular maintenance and cleaning.
• Employees. Staff working in pharmaceutical manufacturing must have the expertise and training to maintain a GMP-compliant facility.
• Operational procedures. GMP audits look at your procedures, specifically the technologies and principles at play during the manufacturing process. Using outdated tools is a mark against your business.
• Process control. You also have to prove that you are following those procedures through documentation. A proactive approach to ensuring GMP compliance is essential. Learn more about the 5 GMP components

Whether you’re following the current Good Manufacturing Practice guidelines of the U.S. Food and Drug Administration (FDA) or the requirements of the European Medicines Agency (EMA), GMP Compliance is a must-have, no matter what markets you serve. It guarantees that your facility:

• Takes steps to protect the quality and efficacy of your pharmaceutical products and medical devices.
• Cares about the health and safety of your patients.
• Prepares itself for audits.
• Avoids sanctions, fines, and penalties.

A GMP Compliance certificate boosts your reputation in a competitive market, and more customers and business partners will want to work with you as a result.

The FDA does not explicitly require cGMP certification, but it does regularly audit pharmaceutical and medical device manufacturers to check whether they are following cGMP guidelines.

Despite the lack of requirement, manufacturers should seek GMP certification for their professionals and facilities to give credibility in the market and give customers and business partners reasons to select you over the competition. It also exposes your staff to cGMP training courses, which supports their professional development.

Certifying your manufacturing facility through a third-party auditor also ensures that your internal processes are compliant and that you document your GMP procedures carefully.

Our cGMP certification program is available to any individuals located in the United States, United Kingdom, Canada, Australia, and European Union member states. See the full list of countries