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GMP News Overview 2007

109619.12.2007Identification and Classification of Deficiencies in Glass Packaging Materials
109519.12.2007New GMP-Guide on Qualification Approved by the ASTM
109113.12.2007ICH Publishes Annex to ICH Q8
109013.12.2007FDA Modifies cGMP Guide - New Text Published
108705.12.2007FDA Inspections at Biological Drugs Sites
108605.12.2007The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All
108328.11.2007Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement
108228.11.2007New Proposals for Analytical Balances and Quality-Relevant Weighing Processes in the American Pharmacopoeia
107921.11.2007Classification of GMP-Observations in the Various Inspectorates
107821.11.2007EMEA Publishes Draft on Assessment of the Quality of Medicinal Products Containing Existing/Known Active Substances
107415.11.2007European Companies and QPPVs in the Focus of U.K. Pharmacovigilance Inspections
107315.11.2007Implementation of Modern GMP Aspects: Revision of the Annex 2 of the EC GMP Guide as an Example
107215.11.2007New EMEA Guideline Draft on Stability Testing with Modified Testing Conditions
106907.11.2007FDA Estimates Effort for Implementing Requirements for Medical Devices
106807.11.2007EU Commission Publishes Draft of New Variation Regulation
106402.11.2007Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert
106302.11.2007EU Commission and EMEA Plan Extensive Further Development in the GMP Environment
106025.10.2007Clinical Trials in India: recent developments
105925.10.2007FDA Plans Changes to the cGMP Guide (21 CFR 211)
105822.10.2007Swiss Biotech Association and IFAPP in co-operation with the ECA
105722.10.2007New GAMP® Good Practice Guide "Electronic Data Archiving"
105522.10.2007News from the FDA Regarding Inspections, GMP Deficiencies and Recalls
105009.10.2007How to Overcome Problems during Validation of an Alternative Microbiological Test System?
104909.10.2007European Commission Releases New GMP Guide Annex 2 for Biologics for Consultation
104809.10.2007EMEA Publishes New HMPC Guideline on Combination Herbal Medicinal Products
104404.10.2007India's Central Drug Authority Gets More Power to Control Clinical Trials
104304.10.2007Outsourcing: What Has to Be Taken into Account from a GMP Perspective?
104204.10.2007Update of USP General Chapter <1010> "Analytical Data - Interpretation and Treatment" Suggested
103826.09.2007EMEA Publishes Updated Questions & Answers Guidance on Variations
103726.09.2007USP Chapter <643> TOC and <645> Conductivity in Revision
103626.09.2007UK Pharmaceutical Industry Association Revises Guidelines for Phase I Trials
103219.09.2007FDA CDER Publishes Facts-and-Figures Document
103119.09.2007FDA Publishes Guideline for Eligibility Determination for Donors of Human Cells and Tissues
103019.09.2007PIC/S Publishes New Version of GMP Guide
102712.09.2007Current EMEA Statements regarding the Introduction of the Harmonised Test Methods in Microbiology
102612.09.2007Raman Spectroscopy in the USP
102205.09.2007EDQM Issues Q&A Documents on Harmonised Microbiological Test Procedures
102105.09.2007ISPE Publishes White Paper on "Dedicated Facilities"
101729.08.2007Harmonisation of EMEA GMP/GDP and GCP Inspectors Groups
101629.08.2007Revision of the EU Variations Regulations
101222.08.2007EU GMP Guide Annex 6 "Manufacture of Medicinal Gases" Draft Revision published for Public Consultation
101122.08.2007EMEA Publishes Guideline on Strategies to Identify and Mitigate Risks in first-in-human Clinical Trials with IMPs
100716.08.2007EMEA Publishes Q&A Document on the ASMF Procedure and on Specifications of Residual Solvents
100616.08.2007USP Publishes Revised General Chapter on NIR and Takes Account of the Increased Use of NIR in PAT
100308.08.2007Free Webcast from the Chairman of the European QP Association Available
100208.08.2007MicroSeq Chapter of ECA's RMM Good Practice Guide published for discussion
100108.08.2007ISO Standard 15378 with GMP Requirements to Manufacturers of Primary Packaging Materials Adopted as EN Standard
99701.08.2007Free Webcast with Chairman of ECA's Working Group on Rapid Microbiological Methods Dr Robert Johnson
99601.08.2007EMEA Provides Guidance for Implementing Harmonised Microbiology Chapters
99501.08.2007USP General Chapter <1226> Comes into Force on 1 December 2007
99226.07.2007Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA)
99126.07.2007MHRA Publishes Pharmacovigilance Inspection Metrics Reports for 2006
99026.07.2007FDA's CBER Updates Q&A List Concerning the Current Good Tissue Practice (CGTP) Final Rule
98718.07.2007New Guidance Published in Eudralex Volume 10 - Clinical Trials
98618.07.2007FDA's Office CBER Publishes Q&As on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
98311.07.2007EMEA Holds Workshop on First-in-Man Clinical Trials Draft Guideline
98211.07.2007FDA Representatives Conduct Q&A Session on OOS Results
97904.07.2007Harmonisation of Pharmaceutical Water Requirements in Pharmacopoeias Continues
97804.07.2007FDA Announces Expansion of Cooperation with EC and EMEA
97528.06.2007EMEA Facilitates Proposal to Establish a Harmonised Format for IMP Batch Release Certification
97428.06.2007EMEA Issues SOP on Coordination of Pre-Approval GxP Inspections
97120.06.2007TOC in the Japanese Pharmacopoeia
97020.06.2007Changes to Chapter 5 of the EU GMP Guide Proposed
96713.06.2007FDA's CVM Publishes New Guidances on CMC
96613.06.2007GMP-Compliant Sanitisation of Pharmaceutical Water Systems
96206.06.2007Dr Robert Johnson Appointed Chairman of ECA RMM Working Group
96106.06.2007ICH Q10 Emphasises Quality Management Systems
96006.06.2007Proposed Change for Dissolution Performance Verification Testing
95731.05.2007ICH Publishes Q10 Guideline as Step 2
95630.05.2007Richard Bonner Accepts Nomination as Director Regulatory Affairs for the European Compliance Academy (ECA)
95530.05.2007Final FDA Computerized Systems Guideline available
95430.05.2007OECD Analyses Economic Effects of Counterfeiting and Piracy of Pharmaceuticals
95023.05.2007EMEA Analyses Quality Defects in Centrally Authorised Products
94923.05.2007Supplier Qualification in the Focus of EU GMP Inspectorates
94514.05.2007LIMS/CDS Get More Attention in Inspections
94414.05.2007EMEA Launches EudraGMP Database
92814.05.2007Justification of Limits for Cleaning Validation in the Manufacture of Active Pharmaceutical Ingredients
94109.05.2007European Qualified Person Association Presents Results of Members Survey
94009.05.2007FDA Withdraws Recognition of Alternative Pharmacopoeias (BP/EP/JP)
93909.05.2007USP Defines New Procedure for Reference Standards
93603.05.2007The Product Quality Review in the Focus of Inspections
93503.05.2007EMEA Reflection Paper on Handling Deviations
93225.04.2007USP Harmonises Requirements on Sterile Water
92719.04.2007EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates
92618.04.2007Annual Review 2006
92517.04.2007Current GMP and Regulatory Developments on Active Pharmaceutical Ingredients
92212.04.2007EMEA Publishes Set of Auditing Documents for Joint Audit Programme
92112.04.2007The UN International Narcotics Control Board Warns of Counterfeit Medicines
91803.04.2007Current FDA Activities
91703.04.2007European Commission Publishes Draft of GMP Directive on Certain Excipients
91428.03.2007Deviations and Failure Investigation - CAPA in the light of FDA Inspections
91328.03.2007UK MHRA Publishes Guidance for Qualified Persons
91021.03.2007FDA Director Steven Galson presents CDER update
90921.03.2007Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections
90821.03.2007Multi User Version of the GMP Guideline Manager Software for Company Members
90514.03.2007New Version 9.0 of GMP Navigator Software Released under New Name
90314.03.2007Process Validation Again Among the Top Five in the Warning Letters Report for Medical Devices
90414.03.2007ISPE Publishes New Guideline on Water and Steam Systems
90008.03.2007Pharmaceutical Engineering in the Focus of EMEA Inspections
89908.03.2007Biofilms as the Cause of OOS/OOT Results
89601.03.2007The Product Quality Review gets down to business
89501.03.2007New HMPC Guideline Published
89221.02.2007EMEA Publishes 2007 Work Plan for Ad Hoc GMP Inspection Services Group
89121.02.2007EMEA Publishes Content of the GMP Inspections Database for the First Time
88814.02.2007FDA Requests More Budget for Public Health Goals
88714.02.2007USP Statement on Dissolution Testing
88407.02.2007Global Efforts in Cold Chain Management and Good Transportation Practice Increase
88307.02.2007New Draft of Chapter 1 "Quality Management" of the EU GMP Guidelines Published
87931.01.2007FDA Requirements on Reporting and Interpreting OOS Results
87831.01.2007FDA 483s Available on the World Wide Web
87424.01.2007List of New, Withdrawn and Revised FDA Guidances Published
87324.01.2007EDQM Publishes TOP TEN Deficiencies Found in Applications for CEPs
87016.01.2007Validation Aspects in US FDA Warning Letters
86916.01.2007EMEA Publishes Concept Paper on Annex 11 - Computerised Systems
86510.01.2007New HMPC Guidelines for Herbal Medicinal Products
86410.01.2007Warning Letters Report 2006

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