GMP NEWS 2006

ECA Working Group on Rapid Microbiological Methods (RMM) Offers Membership

FDA Advisory Committee discusses new Quality Guidances and Initiatives

European QP Association's first QP Forum a Complete Success

Postponed Implementation of USP Microbiology Chapters

FDA Criticises Maintenance and Cleaning of Equipment

Active Substance Master File Guideline in Revision

Publicly accessible Webinar on FDA Study Results

Comprehensive FDA Study on Inspections and GMP Deviations Published

EMEA Publishes New Q&A Document on Its Website

APIC Revises Third-Party Auditing Programme for APIs

Delegation of GMP-Inspections within the EU

ICH collaborates with Standards Development Organisations to enforce globalisation of its standards

Readability of Label and Package Leaflet - Revised Draft of the European Commission

FDA Defines the "Term Quality Unit"

Significance of USP General Chapters above <999> for FDA

ICH Q9 - Training Material Published

Analysis of GMP Inspections by MHRA

Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised

Eudralex Volume 10 Summarises Requirements on Clinical Trials

New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests

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Bioburden Workshop - Regulatory Expectations and Practical Experiences

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