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GMP News Overview 2008

124906.08.2008Current Interpretation of the FDA Requirements on Sampling
124806.08.2008EDQM publishes Update on Heparin Monograph and Policy Paper for dealing with potentially genotoxic Impurities
124530.07.2008Joint Inspections and Further Cooperation between EMEA and FDA Announced
124430.07.2008FDA Publishes New Guideline on the Manufacture of Phase 1 Investigational Medicinal Products
124023.07.2008OECD: Biotechnology Update of the Internal Co-ordination Group of Biotechnology
123923.07.2008The FDA Clinical Investigator Inspection List
123416.07.2008EDQM publishes new Requirements for the CEP Certification Procedure
123516.07.2008European Commission publishes new Variations Regulation Draft
123109.07.2008U.S. Department requests higher Budget for FDA
123009.07.2008EMEA Updates Inspection Manual with Reference to ICH Q9
122702.07.2008Draft Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy Medicinal Products
122602.07.2008ICH Guideline Q10 "Pharmaceutical Quality System" Finalised
122325.06.2008FDA publishes draft of Biological Product Deviation Reports Summary
122225.06.2008Will the Quality by Design Approach Increase Costs and Resources?
121918.06.2008Visions of CBER for Vaccine Manufacturing
121818.06.2008New Amendments to Eudralex Volume 10
121411.06.2008European QP Association Initiates Shared Audit Database
121311.06.2008Medicine Counterfeits: EU Commission publishes Comments from Associations
121004.06.2008Consequences of the Guideline 98/8/EG and the Biocide Act for the pharmaceutical industry
120904.06.2008European Commission, EMEA and FDA decide to intensify cooperation
120629.05.2008Training Slides on Validation from the WHO
120529.05.2008GHTF Publishes Auditing Guideline
120221.05.2008EDQM publishes "Guide to the Preparation, Use and Quality Assurance of Blood Components"
120121.05.2008New FDA Plans Intend to Ensure Drug Safety for Imported Products
119714.05.2008Risk-based Inspection Programme - a Model for Future Inspections?
119614.05.2008New Draft of Inspection Guideline on Tissue and Cell Procurement
119514.05.2008Revised Chapter 4 of the EU Guideline to GMP Released for Public Consultation
119107.05.2008Adoption of the Commission Proposal on Variations (co-decision part)
119007.05.2008PIC/S Publishes Guideline for GMP in Healthcare Establishments
118907.05.2008Will the FDA Continue Its Initiative "cGMPs for the 21st Century"?
118530.04.2008European Compliance Academy (ECA) Initiates New Working Group
118430.04.2008EU Plans Extension of GMP Guide for APIs to Quality Risk Management
118330.04.2008ICH Q11 - A New Guideline for the Development of APIs Is Being Created
117923.04.2008Draft Annex 13 Released: European Commission Asks for Comments
117823.04.2008EMEA Issues Statement on WFI Preparation through Reverse Osmosis
117723.04.2008New FDA Guidance on Dissolution Testing: No Calibrator Tablets!
117216.04.2008EMEA Publishes Q-and-As on Genotoxic Impurities
117116.04.2008EU Publishes New Version of EU GMP Guide Annex 11 "Computerised Systems"
117016.04.2008FDA Reacts to Recent Problem Cases and Establishes GMP Inspection Office in China
116709.04.2008FDA Withdraws Changes to the cGMP Guide (21 CFR 210/211)
116609.04.2008Consultation on the Revised Annexes 1, 2 and 3 on the Clinical Trial Application Form
114709.04.2008European Commission Plans Far-Reaching Changes to GMP and GDP in the Fight against Counterfeit Medicines
116202.04.2008Chinese Regulatory Agency: Drug and API Importers are Responsible for Supply Quality
116102.04.2008Deviations and Failure Investigation - CAPA in the Light of FDA Inspections
115826.03.2008USP General Chapter <1058> Analytical Instrument Qualification Comes into Force on 1 August 2008
115626.03.2008FDA Confirms Use of "Container Closure System Integrity Testing" instead of "Sterility Testing" in Stability Testing
115219.03.2008EMEA Releases Concept Paper on a Guideline on Documentation Concerning Biological IMPs
115119.03.2008FDA Provides Certifications to Accompany Applications or Submissions on Website
114619.03.2008New Version 10.0 of GMP Guideline Manager Software Released - Free of Charge for ECA Members
114412.03.2008Annual Review 2007
114312.03.2008GMP for Excipients - The USP General Information Chapter <1078> under Revision
114212.03.2008CDER Guidance Agenda Published
113805.03.2008FDA Requests Nearly $2.4 Billion as Part of the President's Fiscal Year (FY) 2009 Budget
113705.03.2008Handling of OOS Results Still an Important Issue in FDA Inspections
113605.03.2008Warning Letters Report 2007 Frequent Deficiencies in Quality Control Labs and in the Clearing of Deviations in Production
113504.03.200810th APIC Conference on Active Pharmaceutical Ingredients
113128.02.2008FDA Approval for Parenteral Products in Plastic Immediate Containers
113028.02.2008FDA Guidance on Alternative Sterility Testing
112928.02.2008New EMEA Paper on Markers for Herbal Medicinal Products
112621.02.2008EMEA Issues Statement on Status of Revision of GMP Guide Concerning "Dedicated Facilities"
112521.02.2008EU Publishes Changes to Chapter 1 EC GMP Guide and Annex 20
112421.02.2008New Version of Annex 1 to the EC GMP Guide on Sterile Manufacture Published
111913.02.2008List of New, Withdrawn and Revised FDA Guidances Published
111813.02.2008EMEA's Piotr Krauze Confirmed to speak at ECA Good Development Conference
111713.02.2008Eudralex Volume 10 Updated
111306.02.2008Outcome of the Public Consultation of the Review of the Variations Regulations (Comitology Part) Published
111206.02.2008Expert Team of German Medicines Manufacturers' Association Develops Quality System Manual
111106.02.2008EU Council Adopts EFPIA Joint Technology Initiative on Innovative Medicines
110830.01.2008FDA Foreign Inspection Programme under Review
110730.01.2008Medical Devices Warning Letters Report 2007 - Process Validation Again among the Top 5
110424.01.2008European QP Association Plans on Launching Interest Group for Advanced Therapies
110324.01.2008FDA Reacts to Report Accusing the Authority of Serious Deficiencies
110016.01.2008Amendment to Chapter 5 of the GMP Guide ("Qualification of Suppliers") Expected in Early 2008
109916.01.2008Recognition of Compendial Methods - EMEA Publishes New ICH Q4B Documents

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