Understanding the FDA Compounding Pharmacies Guidance

Why Should You Attend:

The FDA has recently been cracking down on Compounding Pharmacy facilities due to the fungal meningitis outbreak in 2012 that caused 60 deaths and 750 cases of infection. As a result of this, the Agency is not confident in the ability of Compounding Facilities to maintain a state of control on their facilities and the conditions under which the product is compounded. Many of the insanitary conditions described by the Agency are outlined in this guidance document.

The process of aseptic filling of final drug products provide an excellent reference when it comes putting the proper procedures and controls into place for preventing many of the insanitary conditions outlined in the guidance document. By understanding how final drug product is aseptically filled, Compounding Pharmacies can implement many of the controls used. The guidance reference the industry uses to process products aseptically is the Aseptic Processing Guidance Document –Sept 2004. By reviewing and implementing the concepts in this document, many of the examples of insanitary conditions outline the proposed guidance document can be eliminated.

Areas Covered in the Webinar:

• History of reason why the Compounding Pharmacy Guidance document is being implemented.
• Overview of the Aseptic Processing Guidance Document – Sep 2004.
• Reviewing the Aseptic Guidance document and how it implies to the insanitary conditions described in the proposed guidance document.
• Examples on how the concepts outlined in the Aseptic Processing Guidance document can be implemented.

Who Will Benefit:

• Quality Assurance Managers and Directors
• Quality Control Personnel
• Supervisors, and Managers involved in Compounding Drug Products
• Consultants
• Regulatory and Compliance Management
• Regulatory Affairs Professionals

Carl Patterson
QA Team Lead, Bachem

Carl Patterson is a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in biology, microbiology, and biochemistry officially began when he served in the U.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

To date, Carl has now garnered over two decades’ worth of extensive hands-on expertise. Currently, he is the Chief Consultant of his very own consultant business called aseptic-process.net, where he specializes in the aseptic processing of pharmaceutical products in the pharmaceutical manufacturing sector.

Furthermore, Carl holds various degrees and certifications, including an M.S. in Biomedical Quality Systems from San Diego State University, a B.S. in Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

Topic Background:

The Compounding Pharmacy industry has recently been criticized by the FDA for mixing products that have caused considerable patient harm due to sterility. The guidance document describes conditions under which the agency considers insanitary. The Agency’s guidance is vague, it is up to Compounding Pharmacies to prevent any insanitary conditions and put the proper controls into place to prevent insanitary conditions from occurring.

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