FDA Publishes 5 New Guidances

Under the title "Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report - Fall 2004", the Agency explains its new GMP compliance strategy. In this context, the following guidelines have been published:

You will find links to download the guidelines at the bottom of this news page.

With these guidances, the Agency has opened a new chapter in GMP compliance.

In the Progress Report, the FDA itself is writing:

"We regulate the manufacture of pharmaceuticals to ensure that the drug supply in the United States is of consistently high quality. In the past, as a result of the many uncertainties in drug manufacturing, we exercised extensive control over every aspect of the process. Over the past year, we have completed a rigorous assessment of current practices and the available new tools of manufacturing science that would enable a progression to controls based on quality systems and risk management. The assessment adhered to five guiding principles:

Risk-based orientation.
Science-based policies and standards.
Integrated quality systems orientation.
International cooperation.
Strong public health protection."

The FDA already informed about the contents of these new guidances in Washington from 20-22 September on the occasion of an event that was in part organised by the authority itself. Of course, we were there for you. You can benefit from this fact via our GMP news and our courses and conferences focussing on these topics. In the next few days, we will provide you with further details. We would just like to anticipate one thing: In Washington, David Horowitz, Director of the Office of Compliance, talked of a change of paradigm. Not only Good Manufacturing Practices, but Best Manufacturing Practices are the declared aim of FDA. Here, the most important task is to establish modern methods of quality assurance. With the help of modern methods for process monitoring and control (e.g. NIR, chemicals imaging), the reproduction quality is meant to be improved. By means of quality systems, the companies are meant to establish a permanent process of internal review in order to reach continuous improvement.

The hitherto valid interpretation of the GMP requirements for the field of aseptic processing laid down in FDA's "Guideline On Sterile Drug Products Produced By Aseptic Processing" dates back to June 1987. Many of these contents were not up to the modern requirements on the manufacture of aseptic products any more. On 3 September 2003, the FDA had published an official Draft "Guideline On Sterile Drug Products Produced By Aseptic Processing". On 29 September 2004, the FDA now published the final guidance.

• PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance [PDF] [HTML] [DOC] (Posted 9/29/2004)
• Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice [PDF] [HTML] [DOC] (Posted 9/29/2004)

• Computerized Systems Used in Clinical Trials [PDF] [HTML] [DOC] (Posted 9/29/2004)
• Current Good Manufacturing Practice for Combination Products [PDF] [HTML]  [DOC] (Posted 9/29/2004)
• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations [PDF] [HTML] [DOC] (Posted 9/29/2004)

Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach Final Report - Fall 2004 (posted 9/29/2004)

Please note: The Final Report refers to further documents and White Papers. We will soon inform you in detail about it.

Author:
Oliver Schmidt
CONCEPT HEIDELBERG