Good Manufacturing Practices (GMP) Facility Certification Program

The FDA views a CGMP audit certificate, from a respected auditing service, as a positive step in meeting corporate CGMP responsibility.  Small companies, start-ups, and even those adding a new product or product line will benefit from this audit programs certificate.  The FDA wants to see that management is involved in their GMPs.  This certificate is a big step in proving to any regulatory agency (FDA, EMA, others) that the company takes GMPs seriously and is being proactive in meeting the goals of the regulation.

Another benefit of the audit GMP program is that is can be adapted and used for vendor audits; even if the vendor is not a GMP facility.

The Process

 

There are five (5) major steps that need to be taken so that a complete evaluation of the facility and operation is achieved in a timely (and cost effective) manner.  CfPIE will provide highly qualified staff to complete the program and to help assure compliance to current FDA expectations. 

The audit will start with a review of necessary and expected documentation that supports the operation and production of the product(s).  All areas of the operation are included in the audit, but not limited to, are:

  • Receiving/Shipping
  • Laboratories/Stability
  • Compounding
  • Filling
  • Labeling
  • Complaints/Investigations

Following the document review, a careful site visit will take place.  This is to evaluate the flows (materials, people, air, etc.) as well as adherence to GMP principles in manufacturing.  Each area will be evaluated independently and a score established and show facility strengths and weaknesses.  IF any weaknesses are found remediation suggestions will be provided.  These recommendations are based on Quality Systems and Risk Management approach (ICH and FDA Q8, Q9, and Q10) will be key to evaluation of the audit findings.  

Prior to starting the 5-step process, CfPIE will conduct a Discovery Session to assess your information starting with a phone call or web conference. Contact us to learn more.

The Proof

 

Upon approval, clients who have completed the process will receive permission to show the GMP Validation Seal on their website and others materials with a unique seal of approval and a disclaimer. The Seal serves as proof that their facilities have met the requirements for GMP compliance.




 

Meet Our GMP Team

Steven A. Ostrove, Ph.D.

Kenneth Cleaver, Ph.D.

Kerry Potter

 

Jerry Lanese, Ph.D.


 

 

Richard F. Newmiller