GMP NEWS 2005

GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?

Biological Product Inspection Issues and Regulatory Update

New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published

Barr Judgement on the Internet

Third-Party GMP Audit at Genzyme Pharmaceuticals

New Version 7.0 of the CD-ROM GMP Navigator Has Been Released

EMEA and FDA Intensify Their Co-operation

New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation

Summary of Changes in the Notice to Applicants

FDA Publishes a New Draft Guideline on Impurities in Raw Materials

ICH Q 9 on Quality Risk Management published!

Validation of Computer-Based HPLC Systems

Stronger Emphasis of Supplier Audits Concerning Packaging Materials

New GMP Initiative Published by EU Commission and EMEA

New Draft for a USP Monograph on the Qualification of Analytical Instruments

FDA Findings During Inspections on Design and Construction of Equipment

US FDA GRANTED OBSERVER STATUS TO EUROPEAN PHARMACOPOEIA COMMISSION

Annual Review 2004

EMEA: Activities of Inspections Sector

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