"CDER 2004 Report to the Nation" Published by FDA

GMP News No. 610

GMP News
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 Course:

In addition, the European Compliance Academy is organising the following events dealing with the deviations Top 3 and Top 10 respectively:

Compiled by:
Oliver Schmidt

Source: The Center for Drug Evaluation and Research 2004 Report to the Nation

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