GMP NEWS 2013

1997 - 2003 - 2013: Quo vadis 21 CFR 11?

What is the current status concerning US 21 CFR Part 11 - Electronic Records, Electronic Signatures? 16 years after the release of the regulation and 10 years after a period of intensiv discussion you can read a short  summary about the situation today. To read more see here.

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EMA publishes revised dossier-submission requirements for active-substance master files

The European Medicines Agency has updated its pre-authorisation procedural advice for users of the centralised procedure to reflect new requirements for the submission of active-substance-master-file (ASMF) dossiers as part of human or veterinary marketing-authorisation or variation applications. Go here to read more.

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FDA Launches Secure Supply Chain Pilot Program

With a new program, the FDA intends to enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products into the United States. Read more.

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WHO publishes revised draft on GTDP for pharmaceutical starting material

The WHO has published a proposal to revise the Good Trade and Distribuiton Practices for Pharmaceutical Starting Materials. Read more.

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Overview of the Requirements on WFI in the EU, USA and Japan

What are the different requirements on WFI in the EU, USA and Japan? The answer to this frequently asked question can be found here.

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Container Performance Testing - New Proposal for USP General Chapter <671>

Pharmacopoeial Forum 39 (2) contains a proposal for the revision of USP General Chapter <671>. Packaging systems have to demonstrate satisfactory container-closure integrity throughout the product's shelf life. It is proposed that this USP chapter will be revised to include a new permeation method for determining barrier protection for packaging systems. You will find more information in this news.

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EXCiPACT - Pilot Phase Successfully Completed!

After a successful completed pilot phase, the ExcipactTM scheme will further expand as quality standard for GMP and GDP audits of manufacturers of pharmaceutical excipients. Read more here about the worldwide recognised audit scheme.

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New FDA Fees for Drug Master Files published

The US FDA has published the new fees for 2014. Please read more about the Drug Master File Fee and the API Facility Fee in our GMP News.

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Revision of the USP Chapter on Packaging and Storage Requirements

The proposed revision of Chapter <659> on Packaging and Storage Requirements shall help ensuring in the future that the definition of the "single-dose-containers" term is used correctly. In addition, the storage conditions for medicinal products have been defined completely. Read more here in the News.

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FDA started Initiative for DUNS Numbers of Pharmaceutical Sites

In one of our last News, we reported about the DUNS numbers for the identification of pharmaceutical sites in Site Master Files. Last year, the FDA also started an initiative for the DUNS numbers. Read more.

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USP visual inspection expert answers question regarding AQL testing

Questions about the implementation or the need for AQL testing in the visual inspection of parenteral drugs are becoming more frequent. To get concrete answers to a specific question read on.

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USP Elemental Impurities Implementation Advisory Group - Meeting Summary

The newly formed USP Elemental Impurites Implementation Advisory Group considers issues experienced by manufacturers of products especially affected by the elemental impurities standards. Read more about the output of the Group's last meeting.

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ASEAN Countries publish Draft of a Guideline on Process Validation

The member states of the Southeast Asian association (ASEAN) have released the draft of a process validation guideline under the management of Singapore. The title is "Guidance for Quality by Design as an alternative Approach to Process Validation". The document is composed of 10 pages and is very much in line with... Read more here.

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Have you ever heard about the Dun and Bradstreet Verification in the EU Site Master File?

With the binding mention of a Site Master File in revised Chapter 4 of the EU GMP Guide, the document has become obligatory for all pharmaceutical companies. The EU Site Master File contains a few essential changes to the previously applicable PIC/S Guideline PE 008-3. In the new version for example under section ... read on.

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New FDA Regulation gives the Agency more Power during an Inspection

FDA is proposing a regulation to implement administrative detention authority during inspections, which might present a new risk to facilities. Read more.

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FDA: Import of Drugs prior to approval

The U.S. Food and Drug Administration FDA has issued a draft guidance to define how the agency intends to deal with requests to import unapproved drug products. Read more.

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Quality by Design: Lessons learnt from EMA/FDA Pilot Program

EMA and FDA published a joint report on the pilot program on Quality by Design (QbD) applications. Read more.

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EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

The European Medicines Agency has published the final Guideline on pharmaceutical development of medicines for paediatric use. The date for coming into effect is 15 February 2014. Read more.

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New FDA Guidelines for Medical Devices

Because of the number and complexity of medical devices, FDA's Center for Devices and Radiological Health (CDRH) has published many new guidelines. This makes it difficult to keep track of the current situation. In the following, we have compiled a selection of new FDA documents with regard to aspects of quality assurance and marketing authorisation ... Read more here.

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What about the Successor Organisation (IMDRF) of the GHTF?

In one of our News we reported about the end of the Global Harmonisation Task Force (GHTF) and presented the International Medical Device Regulators Forum (IMDRF) as successor organisation. For a start, the IMDRF has taken over the "old" GHTF guidelines and plans to develop them further successively where necessary. First efforts have now been made. Read more here ...

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