GMP News Overview 2005

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GMP News Overview 2005

Nr. Date Title

654 23.12.2005 Inside News: GMP Webinars - The New Online Seminars

653 20.12.2005 New EMEA Document Questions the 3 Validation Batches for the First Time

652 16.12.2005 Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light

648 08.12.2005 Analysis of GMP Inspections by MHRA

647 08.12.2005 ICH Q9 on Quality Risk Management Now Available

641 01.12.2005 EU GMP Guide: New Draft for Annex 1 "Sterile Manufacturing" Published

644 01.12.2005 ICH Q8 Guideline Now Available in PDF Format

642 01.12.2005 FDA and EU Extend Confidentiality Arrangements

643 25.11.2005 Product Recalls Due to OOS Results

636 21.11.2005 ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come

635 21.11.2005 Changes to the EU GMP Guide Passed

629 25.10.2005 EC Commission Publishes the Restructured EU-GMP Guide!

631 25.10.2005 Statistics on FDA Inspections

630 24.10.2005 Impurities in Generics - New FDA Draft Guidance for Industry

625 17.10.2005 ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -"

623 12.10.2005 FDA Applies for PIC/S Membership

621 11.10.2005 SOP by EMEA on Inspections

622 11.10.2005 Laboratory Activities in the Focus of FDA Inspectors

616 06.10.2005 New ECA Mission Published

615 06.10.2005 Daniel Scheidegger Appointed New ECA Chairman

614 04.10.2005 New FDA Developments

613 29.09.2005 Increase in FDA Warning Letters to European Pharmaceutical Companies

608 20.09.2005 Revision of the EMEA Inspection Guideline

610 20.09.2005 "CDER 2004 Report to the Nation" Published by FDA

604 14.09.2005 Revision of USP Chapter <1116> on Environmental Monitoring

605 13.09.2005 New USP Drafts on Pharmaceutical Water and Steam

598 01.09.2005 EDQM's Inspection Programme

597 01.09.2005 New USP Requirements with an Influence on the Handling of OOS Results

596 01.09.2005 New EMEA Guideline on Plastic Packaging Materials

591 22.08.2005 FDA Published ICH Q9 "Quality Risk Management"

590 22.08.2005 ECA's Annual Advisory Board Meeting in Heidelberg

589 22.08.2005 Two Recent Warning Letters for Manufacturers of Sterile Products

588 15.08.2005 FDA Published New Q-and-A on cGMP

580 25.07.2005 Results of Inspections of Manufacturers of Sterile Medicinal Products

579 25.07.2005 Which Firms Will the FDA Inspect More Frequently in the Future?

578 22.07.2005 Current FDA Opinions on Regulatory Affairs, Inspections and GMP

574 05.07.2005 Young scientists can participate in ECA Biotech Conference free of charge! - Johnson & Johnson donates 5 participations

573 04.07.2005 Comparability of Biotechnological Products - New Guidance Documents from FDA and EMEA

572 04.07.2005 Restructuring the EG GMP Guide

565 30.05.2005 ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed

563 30.05.2005 GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?

562 25.05.2005 Biological Product Inspection Issues and Regulatory Update

559 24.05.2005 New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published

558 20.05.2005 Barr Judgement on the Internet

557 20.05.2005 Third-Party GMP Audit at Genzyme Pharmaceuticals

553 11.05.2005 New Version 7.0 of the CD-ROM GMP Navigator Has Been Released

552 10.05.2005 EMEA and FDA Intensify Their Co-operation

551 09.05.2005 New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment

550 25.04.2005 ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation

549 25.04.2005 Summary of Changes in the Notice to Applicants

539 12.04.2005 FDA Publishes a New Draft Guideline on Impurities in Raw Materials

543 06.04.2005 ICH Q 9 on Quality Risk Management published!

538 01.04.2005 Validation of Computer-Based HPLC Systems

537 01.04.2005 Stronger Emphasis of Supplier Audits Concerning Packaging Materials

530 11.03.2005 New GMP Initiative Published by EU Commission and EMEA

526 08.03.2005 New Draft for a USP Monograph on the Qualification of Analytical Instruments

525 07.03.2005 FDA Findings During Inspections on Design and Construction of Equipment

524 03.03.2005 US FDA GRANTED OBSERVER STATUS TO EUROPEAN PHARMACOPOEIA COMMISSION

519 22.02.2005 EMEA: Activities of Inspections Sector

521 22.02.2005 Annual Review 2004

515 15.02.2005 New APIC Guidance on the Qualification of Existing Equipment Published

514 14.02.2005 FDA Warning Letter Report 2004 Published

513 10.02.2005 Recently published APIC Industry Best Practice documents

509 02.02.2005 Frequently Requested Inspection Documents on FDA's Website

507 02.02.2005 PAT (Process Analytical Technology) in Europe

508 01.02.2005 EMEA Publishes "cGMP Notes"