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GMP News Overview 2006

Nr.DateTitle
86119.12.2006ECA Working Group on Rapid Microbiological Methods (RMM) Offers Membership
86019.12.2006FDA Advisory Committee discusses new Quality Guidances and Initiatives
85713.12.2006European QP Association's first QP Forum a Complete Success
85613.12.2006Postponed Implementation of USP Microbiology Chapters
85511.12.2006FDA Criticises Maintenance and Cleaning of Equipment
85207.12.2006Active Substance Master File Guideline in Revision
85107.12.2006Publicly accessible Webinar on FDA Study Results
84730.11.2006Comprehensive FDA Study on Inspections and GMP Deviations Published
84630.11.2006EMEA Publishes New Q&A Document on Its Website
84321.11.2006APIC Revises Third-Party Auditing Programme for APIs
84221.11.2006Delegation of GMP-Inspections within the EU
83816.11.2006ICH collaborates with Standards Development Organisations to enforce globalisation of its standards
83716.11.2006Readability of Label and Package Leaflet - Revised Draft of the European Commission
83309.11.2006FDA Defines the "Term Quality Unit"
83208.11.2006Significance of USP General Chapters above <999> for FDA
82831.10.2006Analysis of GMP Inspections by MHRA
82931.10.2006ICH Q9 - Training Material Published
82424.10.2006Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised
82324.10.2006Eudralex Volume 10 Summarises Requirements on Clinical Trials
82223.10.2006New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests
81817.10.2006HPLC in FDA Warning Letter
81717.10.2006New ICH Guideline Q4B
81617.10.2006New FDA Activities for Minimising the TSE Risk
81212.10.2006New OOS Guidance by FDA!
81011.10.2006Validation - a New Philosophy Ahead
80805.10.2006FDA Publishes Final Guidance: Quality System Approach to Pharmaceutical cGMP Regulations
80604.10.2006New European QP Association Counts more than 350 Members already
80402.10.2006EMEA Aims at Harmonising the Requirements on Biotechnological Medicinal Products in Clinical Trials
80502.10.2006EMEA Develops GMP Database
80126.09.2006FDA Publishes Guidance Agenda for the Coming Fiscal Year 2007
80026.09.2006Initiative by Members of EU Parliament Calls for GMP Inspections of API Manufacturing Sites within and outside the EU
79720.09.2006New EMEA Guideline on Declaration of Herbal Medicinal Products
79620.09.2006How to Comment FDA Proposed Regulations
79520.09.2006EMEA plans Guideline on Quality of Combination Herbal Medicinal Products
78907.09.2006Product Quality Review - Consequences from the EC GMP Guideline and Authority Expectations
78807.09.2006EMEA supports PAT for Variations
78707.09.2006New USP Chapter for the Pharmaceutical Microbiology
78330.08.2006GMP Webinars Now Available as Recorded Webinars
78230.08.2006EMEA Revises Compilation of Community Procedures
78128.08.2006EMEA Publishes Comments on Draft Guidelines for Herbal Medicinal Products
77721.08.2006Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
77621.08.2006New EMEA Guidelines for Herbal Medicinal Products
77521.08.2006EMEA Plans Revision of NIR Guideline
77421.08.2006Annual Review 2006
77110.08.2006European Compliance Academy (ECA) Advisory Board Establishes European Qualified Person Association
77009.08.2006EMEA Reflection Paper on PAT
76428.07.2006European Compliance Academy initiates Working Group for Rapid Microbiological Methods
76328.07.2006PIC/S revises Guide to GMP for Medicinal Products
76118.07.2006ICH Steering Committee Withdraws ICH Q1 F Guideline
76014.07.2006Qualified Person Must Confirm API-Related Notification of Changes
75704.07.2006Is There a List of Equipment for Pharmaceutical Manufacture Approved by FDA?
75630.06.2006Revision of FDA/EU GMP ISO Matrix - ECA Good Practice Guide
75329.06.2006EMEA's View on the Implementation of RMMs for WFI and Purified Water
75229.06.2006GMP Questions and Answers from the Canadian Authority
74819.06.2006Results of the ECA Survey on Rapid Microbiological Methods - RMMs
74719.06.2006FDA Conducts Workshop for Small Pharmaceutical Businesses
74619.06.2006FDA Announces Withdrawal of 5 and Revision of 2 Guidances
74130.05.2006New FDA Science Forum Documents on Dissolution Testing
74030.05.2006Validation Requirements on the Packaging of Medical Devices
73930.05.2006DoE from the Authorities' Point of View
73524.05.2006Online Seminars Generate Big Interest: Successful Start of the GMP-Webinars
73424.05.2006New EMEA Document on Release Decisions of a Qualified Person
72917.05.2006ASTM Draft Guide: Science- and Risk-Based Approach to Qualification
72815.05.2006FDA's New Validation Approach - The Life Cycle Approach
72712.05.2006EU Requirements on Braille for Printed Packaging Materials
72310.05.2006The current thinking about Rapid Microbiological Methods and PAT
72209.05.2006Risk Management in a New EMEA Paper
72105.05.2006WHO Guidelines on GMP-Compliant Sampling
72003.05.2006The 8th European API Conference in Berlin - A Review
71603.05.2006Withdrawal: FDA's cGMP Regulation and Investigational New Drugs
71428.04.2006FDA's New Compliance Program Guidance Manual, Chapter 45 - Biological Drug Products
71327.04.2006The End of Process Validation?
70919.04.2006Validation of Computerised Systems: Answers to Frequently Asked Questions to GMP Inspectors
70819.04.2006FDA Details Its Visions of the "cGMP for the 21st Century Initiative"
70719.04.2006EMEA Plans Changes in the Field of GMP-Compliant Manufacturing of Investigational Medicinal Products
70411.04.2006Containment Systems under Discussion
70311.04.2006GMP Inspections of Computerised Systems - Which Are the Most Frequent Deficiencies?
70205.04.2006Warning Letters Report 2005
69723.03.2006ECA Internet Survey on Rapid Microbiology
69623.03.2006EMEA plans the revision of various GMP requirements
69523.03.2006New Technical Guide of the European Pharmacopoeia for the Elaboration of Monographs published
69216.03.2006New Version 8.0 of the CD-ROM GMP Navigator Released
69116.03.2006New FDA Compliance Programmeá Guidance for Inspection of API manufacturers
69016.03.2006Media Fills in the Centre of US FDA Warning Letters
68709.03.2006Finally Official: New USP Monograph on Pure Steam
68808.03.2006New EMEA Guideline on Blood and Blood Products
68908.03.2006EMEA Plans Revision of Several Guidelines as well asá New Guideline on Herbal Medicinal Products
68001.03.2006New Annex 19 "Reference and Retention Samples" Effective June 2006
67928.02.2006New FDA Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
67622.02.2006Current Packaging Materials Requirements
67522.02.2006The new PIC/S AIDE-MEMOIRE "INSPECTION OF BIOTECHNOLOGY MANUFACTURERS"
67014.02.2006New Information on ICH Q10 "Quality Systems"
67114.02.2006Problems with the Integration of ICH Q9 into the European Regulatory System
67209.02.2006New FDA Requirements on the Manufacture of Investigational Drugs for Phase 1
66624.01.2006Mike Edgington Named Director for Regulatory Affairs at ECA
66523.01.2006Lubricants in the GMP and HACCP Surrounding
66420.01.2006In-Vitro Pyrogen Testing - Soon Part of the European Pharmacopoeia?
65702.01.2006New Inspection Guideline for GMP Labs
65802.01.2006New Contents of Annex 1 on Clean-Room Classification

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