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News & Trends
Overview
News: Regulatory Cooperation Expanded between FDA, EC and EMEA
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas.
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News: ICH issued Step 2 of the Pharmaceutical Quality System Guideline Q10
The new ICH Guideline Q10 has combined different guides for Quality Systems into one document. This guideline was developed based on the following documents to achieve a global harmonization for the requirements of a modern quality system.
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News: Joint Audit Programme for EEA GMP Inspectorates
Quality Systems Framework for GMP Inspectorates is part of the Compilation of Community Procedures on inspections and exchange of information and referred to in Directive 2003/94/EC Art.3.1.
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News: EU GMP Guide Chapter 1 "Quality Management" under Revision
The European Commission has published the revised Chapter 1 of the GMP Guide for review and commenting.
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News: EMEA Concept Paper for Annex 11
A Concept Paper has been agreed by the Ad Hoc GMP Inspection Services Group proposing a revision of Annex 11 of the GMP Guide in regard to computerised systems. This may involve consequential amendments to Chapter 4 of the Guide for Documentation requirements.
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News: EMEA prepares for entry into force of new legislation on paediatric medicines
A new European regulation on paediatric medicines will be entering into force on 26 January 2007, the implementation of which is a main priority for the European Medicines Agency (EMEA) in its work programme for 2007.
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News: New regulations for API manufacturing in Germany "AMWHV"
Based on the EU Directive 2004/27/EC, amending directive 2001/83/EC, which requires for that all medicine APIs must be manufactured according to the GMP guidelines as defined by ICH-Q7A, Germany's health agency published the 14. AMG-Novelle (14th amendment of the law) on Sep. 06, 2005.
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News: FDA COMPLIANCE PROGRAM GUIDANCE MANUAL for API Inspection
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News: Do CGMPs require three successful process validation batches before a new active pharmaceutical
ingredient (API) or a finished drug product is released for distribution? FDA has published a new statement and updated an existing one. The wording of the statement is as follows: No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process.
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News: CGMPs for the 21st Century
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News: FDA news- Sterile Drug Products
Recently FDA released a number of expected documents, some finalized and some as drafts.
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News: Judge Backs FDA Against Mylan Labs
Associated Press 08.18.2004, 02:14 PM Mylan Laboratories Inc. was dealt a setback by a federal judge who ruled that the Food and Drug Administration violated no law in rejecting the pharmaceutical giant's application for a pain medication patch. To read the full message please click the following link bellow.
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News: FDA Warning Letter Evaluation
Concept Heidelberg regularly splits FDA cGMP warning letter issues to their CFR reference and publishes statistics about most frequently found deviations. As in the past year, the list is headed by § 211.
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News: Pay by credit card
GMP-Online-Consultancy provides you now the opportunity to pay with your credit card by using the PayPal system www.paypal.com. Just place you order and go to shopping cart to complete the order execution and payment by PayPal.
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News: New FDA draft guidance for dispute resolution
A new FDA draft guidance for dispute resolution allows the manufacturing site to challenge FDA inspection findings on the Form 483 10 days after the Form 483 was issued. The district office or applicable ORA office should respond in writing within 30 days.
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New Document:
General Rules for Laboratories Operating under Good Laboratory Practice (GLP)
New Document:
21-CFR 820 Quality Systems Check-list
New Document:
21 Part 11 Compliance Plan
New Document:
Handling of Chemicals, Reagents And Solutions in Laboratories
New Document:
Batch Reprocessing and Reworking for API (Active Pharmaceutical Ingredient)
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