GMP NEWS 2003

FDA Develops Quality Systems Guidance<br>(Labcompliance News from Dr Ludwig Huber)

Adjustment versus Modification - Interpretation of the Ph.Eur. Requirements

ICH Q8 and ICH Q9 Coming Soon!

6th APIC 2003

EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials

Current Inspection Findings of the British Supervisory Authority MHRA (Formerly MCA)

FDA Requirements on the Qualification of Component Suppliers

New PIC/S Guidance on Computer Validation

Analysis of Our Internet Survey of 28 August 2003

First Consequences for Process Validation and Equipment Qualification According to the New FDA Draft Guidance on Aseptic Processing

FDA Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

Final Version: Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application

NEW: PAT (Process Analytical Technology) Draft Guidance from FDA!

Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products?

FDA's Expectations on the Training Documentation of Laboratory Staff

Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment"

Will the GMP Regulations Be Harmonised Worldwide?

Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt

FDA's System-based Approach to Inspections as Reflected in the Warning Letters

Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC

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