GMP NEWS 2010

Verification of Compendial Procedures - Changes Planned in the USP General Chapter <1226>

The Expert Committee of the USP has proposed to revise the General Chapter <1226> Verification of Compendial Procedures in order to better clarify the purpose of the verification process. Find out more about the planned Updates of the USP 35.

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Pharmacopeial Forum (USP) going online and free

USP will be transitioning the Pharmacopeial Forum to a free online resource in January 2011. You can already register now. Read more here. 

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Revision of Chapter 6 of the EU GMP Guide Quality Control - New Concept Paper

Chapter 6 of the EU GMP Guide provides general guidance on the Quality Control Department and Good Quality Control Laboratory Practice. EMA's Concept Paper on the Revision of Chapter 6 recommends that this chapter should be reviewed and that guidance for the transfer of analytical methods from one laboratory to another should be included. For more information please go here.

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What Information on Impurities is necessary for a Marketing Authorisation Application for a generic Medicinal Product in the US?

Recently the Food & Drug Administration (FDA) revised the Guidance for Industry "ANDAs: Impurities in Drug Products" and that way adjusted the regulations for generic medicinal products authorisation dossiers to the ICH Q3B(R2) regulations. Read more here.

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ICH Q7 How to do Guide - Video Presentation of APIC Conference available

During the APIC Conference in Barcelona end of October the new "How to Do" Guide of the APIC, the Association of European API Manufacturers, was introduced and commented. The presentation was recorded, and the video is now available. Read more here.

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EMA Concept Paper on Storage Conditions during Transport

The European Medicines Agency (EMA) has published a concept paper on storage conditions during transport. The goal is to create new Good Distribution Practice (GDP) and GMP guidance. Read more

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New EMA Guideline on the Investigation of Bioequivalence

The European Guideline on the Investigation of Bioequivalence came into effect on 1 August 2010. Further details can be reviewed here.

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Frequently asked Question: How do I find all CEPs suspended by the EDQM?

For a number of reasons, for example when an inspection reveals that a production site does not comply with GMP requirements defined in ICH Q7, a CEP for an API can be suspended. Click here to read more about the list of suspended CEP´s and their holders.

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Concept Paper: Quality Management Challenges in Pharmaceutical Industry

A recently introduced quality management model discusses new processes and their compliance with international developments and governmental expectations as e.g. expressed in the ICH Q10 guideline. Read more.

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Will there soon be a shortage of QPs?

The European QP Association (EQPA), the interest group of European QPs, has published a press release criticising the different interpretation of the applicable Directive in the various Member States. Read more.

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FDA publishes Report on Third Party Audits of Medical Device Manufacturers

Together with Health Canada, the Canadian health authority, the FDA has published a report evaluating a pilot programme of third party audits of medical device manufacturers concerning the reduction of resources. Read more here.

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Questions and Answers on the 'Guideline on the Limits of Genotoxic Impurities'

The Euopean Medicine Agency published a questions and answers document on the Guideline on the limits of genotoxic impurities. The document was adopted by the CHMP on September 23, 2010. Please click here to read more.

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European Commission issues new Draft of Chapter 5 "Production" of the EU GMP Guide

Chapter 5 "Production" of the EU GMP Guide has been revised and was recently published on the European Commission's GMP-information page. The changes offer some surprises and concern the points 5.25, 5.26 and 5.27 on the qualification of suppliers of starting materials.... read on  here.

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FDA becomes official member of PIC/S

At its last meeting in Malaysia, the PIC/S Committee officially invited the FDA (Food and Drug Administration) to join the Pharmaceutical Inspection Co-operation Scheme as from 1 January 2011. Read more here.

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ISPE publishes new Baseline on the Subject of Risk Management

Dated September 2010, the International Society of Pharmaceutical Engineering (ISPE) has published a new baseline entitled "Risk-Based Manufacture of Pharmaceutical Products" (Risk-MaPP). The title implies a broader field of application than actually described in the baseline - read on for more details...

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USP completes Evaluation of Recall of USP 33

The USP (United States Pharmacopeial Convention) has released a public statement outlining the reasons for the recall of USP33-NF 28 while simultaneously presenting the respective corrective and preventive action taken to ensure the future quality of the American Pharmacopeia. Get more details here.

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ECA establishes new Working Group - Invitation to get involved

To address some of the so far not adequately addressed issues in the quality control environment the ECA Foundation decided to establish a new Working Group on Analytical Quality Control. Please read here for further details.

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"Outsourced Activities" - Revision of Chapter 7 of the EU GMP Guide

Chapter 7 of the EU GMP Guide entitled "Contract Manufacture and Analysis" has been revised to a large extent and its title has been changed to "Outsourcing Activities". The draft revision was published on 9 November 2010 with the deadline for public consultation on 28 February 2011. Read about what has changed besides the title of the chapter here.

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Important revision of ISO 14644-1: Clean Room Classification is likely to be changed

The ISO Technical Committee 209 has been working on a revision of the ISO standard 14644-1 for the last four  years to adopt it to current industry thinking and requirements. After a meeting in Oktober 2010 now there are the first news availibe, mentioning the points likely to be changed. The points under discussion will affect all clean rooms used in the pharmaceutical industry as the FDA Aspectic Guide and the EU GMP Annex 1 refer to this standard. Read more.

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FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

The FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus recommends qualification of dissolution test instruments according to the FDA recommendations concerning mechanical qualification. Find further information here.

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