GMP NEWS 2007

Identification and Classification of Deficiencies in Glass Packaging Materials

New GMP-Guide on Qualification Approved by the ASTM

ICH Publishes Annex to ICH Q8

FDA Modifies cGMP Guide - New Text Published

FDA Inspections at Biological Drugs Sites

The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All

Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement

New Proposals for Analytical Balances and Quality-Relevant Weighing Processes in the American Pharmacopoeia

Classification of GMP-Observations in the Various Inspectorates

EMEA Publishes Draft on Assessment of the Quality of Medicinal Products Containing Existing/Known Active Substances

European Companies and QPPVs in the Focus of U.K. Pharmacovigilance Inspections

Implementation of Modern GMP Aspects: Revision of the Annex 2 of the EC GMP Guide as an Example

New EMEA Guideline Draft on Stability Testing with Modified Testing Conditions

FDA Estimates Effort for Implementing Requirements for Medical Devices

EU Commission Publishes Draft of New Variation Regulation

Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert

EU Commission and EMEA Plan Extensive Further Development in the GMP Environment

Clinical Trials in India: recent developments

FDA Plans Changes to the cGMP Guide (21 CFR 211)

Swiss Biotech Association and IFAPP in co-operation with the ECA

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Lab Data Integrity, Part 1 & Part 2

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Lab Data Integrity, Part 1 & Part 2

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