"CDER 2004 Report to the Nation" Published by FDA
GMP News No. 610
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GMP News 20 September 2005 |
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"CDER 2004 Report to the Nation" Published by FDA |
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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:
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Compiled by: Oliver Schmidt Source: The
Center for Drug Evaluation and Research 2004 Report to the Nation |
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity