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GMP News Overview 2005

65423.12.2005Inside News: GMP Webinars - The New Online Seminars
65320.12.2005New EMEA Document Questions the 3 Validation Batches for the First Time
65216.12.2005Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light
64808.12.2005Analysis of GMP Inspections by MHRA
64708.12.2005ICH Q9 on Quality Risk Management Now Available
64101.12.2005EU GMP Guide: New Draft for Annex 1 "Sterile Manufacturing" Published
64401.12.2005ICH Q8 Guideline Now Available in PDF Format
64201.12.2005FDA and EU Extend Confidentiality Arrangements
64325.11.2005Product Recalls Due to OOS Results
63621.11.2005ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come
63521.11.2005Changes to the EU GMP Guide Passed
62925.10.2005EC Commission Publishes the Restructured EU-GMP Guide!
63125.10.2005Statistics on FDA Inspections
63024.10.2005Impurities in Generics - New FDA Draft Guidance for Industry
62517.10.2005ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -"
62312.10.2005FDA Applies for PIC/S Membership
62111.10.2005SOP by EMEA on Inspections
62211.10.2005Laboratory Activities in the Focus of FDA Inspectors
61606.10.2005New ECA Mission Published
61506.10.2005Daniel Scheidegger Appointed New ECA Chairman
61404.10.2005New FDA Developments
61329.09.2005Increase in FDA Warning Letters to European Pharmaceutical Companies
60820.09.2005Revision of the EMEA Inspection Guideline
61020.09.2005"CDER 2004 Report to the Nation" Published by FDA
60414.09.2005Revision of USP Chapter <1116> on Environmental Monitoring
60513.09.2005New USP Drafts on Pharmaceutical Water and Steam
59801.09.2005EDQM's Inspection Programme
59701.09.2005New USP Requirements with an Influence on the Handling of OOS Results
59601.09.2005New EMEA Guideline on Plastic Packaging Materials
59122.08.2005FDA Published ICH Q9 "Quality Risk Management"
59022.08.2005ECA's Annual Advisory Board Meeting in Heidelberg
58922.08.2005Two Recent Warning Letters for Manufacturers of Sterile Products
58815.08.2005FDA Published New Q-and-A on cGMP
58025.07.2005Results of Inspections of Manufacturers of Sterile Medicinal Products
57925.07.2005Which Firms Will the FDA Inspect More Frequently in the Future?
57822.07.2005Current FDA Opinions on Regulatory Affairs, Inspections and GMP
57405.07.2005Young scientists can participate in ECA Biotech Conference free of charge! - Johnson & Johnson donates 5 participations
57304.07.2005Comparability of Biotechnological Products - New Guidance Documents from FDA and EMEA
57204.07.2005Restructuring the EG GMP Guide
56530.05.2005ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed
56330.05.2005GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?
56225.05.2005Biological Product Inspection Issues and Regulatory Update
55924.05.2005New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published
55820.05.2005Barr Judgement on the Internet
55720.05.2005Third-Party GMP Audit at Genzyme Pharmaceuticals
55311.05.2005New Version 7.0 of the CD-ROM GMP Navigator Has Been Released
55210.05.2005EMEA and FDA Intensify Their Co-operation
55109.05.2005New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
55025.04.2005ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation
54925.04.2005Summary of Changes in the Notice to Applicants
53912.04.2005FDA Publishes a New Draft Guideline on Impurities in Raw Materials
54306.04.2005ICH Q 9 on Quality Risk Management published!
53801.04.2005Validation of Computer-Based HPLC Systems
53701.04.2005Stronger Emphasis of Supplier Audits Concerning Packaging Materials
53011.03.2005New GMP Initiative Published by EU Commission and EMEA
52608.03.2005New Draft for a USP Monograph on the Qualification of Analytical Instruments
52507.03.2005FDA Findings During Inspections on Design and Construction of Equipment
51922.02.2005EMEA: Activities of Inspections Sector
52122.02.2005Annual Review 2004
51515.02.2005New APIC Guidance on the Qualification of Existing Equipment Published
51414.02.2005FDA Warning Letter Report 2004 Published
51310.02.2005Recently published APIC Industry Best Practice documents
50902.02.2005Frequently Requested Inspection Documents on FDA's Website
50702.02.2005PAT (Process Analytical Technology) in Europe
50801.02.2005EMEA Publishes "cGMP Notes"

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