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FDA COMPLETES FIRST STEPS OF ITS BROAD INITIATIVE TO IMPROVE REGULATION OF PHARMACEUTICAL MANUFACTURING

In an FDA Fed. Reg. announcement on Feb. 20th, 2003, the FDA declared that it has completed its first steps to improve on how they regulate pharmaceutical manufacturing.

This initiate is the first such program in a long time concerning pharmaceuticals. If the FDA goes on and approves the listed areas, the changes will be substantial to the pharmaceutical industry.

The highlights of what's been completed to date include:

• clarifying the scope of FDA's electronic submission and record-keeping requirements and providing for enforcement discretion in certain areas while FDA considers whether to revise the Part 11 regulations to facilitate innovation for modern manufacturing, electronic record keeping, and regulatory submissions;
• facilitating continuous improvement and innovation in manufacturing by allowing manufacturers to make certain types of changes in their processes without prior FDA approval;
• launching a program to identify and address inconsistencies across program areas with respect to all drug cGMP warning letters;
• issuing for public comment a progress report on improving dispute resolution procedures to facilitate early resolution of scientific and technical disputes and allow for greater transparency;
• clarifying the language used to communicate deficiencies observed during cGMP inspections to better describe the purpose and effect of the investigator's observations issued at the conclusion of an FDA inspection;
• planning public workshops on the scientific foundations of the initiative that will help shape the FDA's next steps in its implementation;
• focusing FDA resources on inspections that are likely to achieve the greatest public health impact (e.g., sterile drug manufacturing);
• providing a progress report that considers adding product and technical specialists with relevant expertise to inspection teams that do not yet include such specialists, a promising step for improving the technical quality and consistency of FDA's inspections; and
• enhancing the agency's expertise in pharmaceutical technologies by hiring a number of additional experts and collaborating actively with academic groups and other outside experts.

The "Pharmaceutical cGMPs for the 21st Century" initiative will include additional intermediate and long-term steps. The major goals of the initiative include:

• ensuring that state-of-the-art pharmaceutical science is utilized in the regulatory review and inspection policies;
• encouraging the adoption of new technological advances in high quality and efficient
  manufacturing by the pharmaceutical industry;
• assessing the applicable cGMP requirements relative to the best quality management practices;
• strengthening public health protection by implementing risk-based approaches that focus both industry and FDA attention on critical areas for improving product safety and quality; and
• enhancing the consistency and coordination of FDA's drug quality oversight activities.

To be able to see the whole announcement, please visit the following link to the FDA’s website:

• http://www.fda.gov/bbs/topics/NEWS/2003/NEW00872.html

Any questions on the initiative or on the FDA and the pharmaceutical or medical device industry please contact mdi directly at info@mdiconsultants.com.

U.S. AGENT SECTION

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