GMP News No. 610
20 September 2005
"CDER 2004 Report to the Nation" Published by FDA
Once a year, the Center for Drug Evaluation and Research publishes a report about its past activities and planned projects. The document's title is "Report to the Nation". This report includes among others information on GMP compliance matters and present FDA initiatives.
1) Improving Manufacturing Practices
FDA's statement: "Our overhaul of the regulatory and quality control systems for pharmaceutical products encourages manufacturers to modernize their methods, equipment and facilities. Our goal is to help eliminate both production inefficiencies and undue risks for consumers. Our initiative implements improved policies that are making better use of our limited resources through more targeted and effective inspections. "
2) Emerging Technologies in Process Validation Recognised
Here, the FDA is announcing: "We revised a longstanding policy document regarding the validation of pharmaceutical manufacturing processes. (NB: this refers to Compliance Policy Guide No. 7132c.08) New to this version is the recognition of the role of emerging advanced engineering principles and control technologies in ensuring batch quality. For drugs produced using these new principles and technologies, we provide for possible exceptions to the need for manufacturing multiple conformance batches prior to initial marketing."
3) cGMP Deviations the Most Common Reason for Drug Recalls
In the report, the FDA also lists the "Top 10 Reasons for Drug Recalls in Fiscal Year 2004". These are:
Top 1: cGMP deviations
Top 2: Subpotency
Top 3: Stability data does not support expiration date
Top 4: Generic drug or new drug application discrepancies
Top 5: Dissolution failure
Top 6: Label mix-ups
Top 7: Content uniformity failure
Top 8: Presence of foreign substance
Top 9: pH failures
Top 10: Microbial contamination of non-sterile products
FDA's current trends and requirements are the focus of the GMP Education
In addition, the European Compliance Academy is organising the following events dealing with the deviations Top 3 and Top 10 respectively: