GMP NEWS 2009

FDA published final Guidance on End-of-Phase 2A Meetings

The FDA Guidance on End-of-Phase 2A Meetings (EOP2A) has now been published in the federal register after a one year public comment period. EOP2A meetings are implemented to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design. Read more.

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Extension of the FDA Pilot Programme for Biotechnological Products

The period for registering for the pilot programme for biotechnological products in order to submit the CMC part in consideration of the QbD approach has now been prolonged by the FDA until 30 September 2010. Find the details here.

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FDA Warning Letter: New Procedure established

The procedure with regard to FDA Warning Letters has changed. The authority now expects an appropriate reply within a very short time frame. New is - among others - the "Close Out Letter" as well as the revised FDA website. Read more here.

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Public Assessment of the Clinical Trials Directive

An assessment of the "Clinical Trials Directive", which had been announced last year, has now been published. A public consultation has also been initiated on this topic. Read more.

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Medical Devices Warning Letter Report 2009 - CAPA Still First

Current FDA Warning Letter Report for Medical Devices lists CAPA again first. Second is... read more.

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ICH Q8 Pharmaceutical Development Completed

The European Medicines Agency (EMEA) has now published what is actually the ICH Q8 document and its annex as ICH Q8 (R2). Read more.

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Webcasts for FDA Transparency Task Force to Public Meetings available

After forming the Transparency Task Force, the FDA has now started holding public meetings. Those who cannot attend the meetings are now able to view a Webcast. Read more.

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FDA Issues Draft on cGMP Regulations for "Combination Products"

The US Food & Drug Administration (FDA) has published a draft with regard to GMP Rules for Combination Products. These are products consisting of a combination of a medical device, a drug and/or a biological product. Read more here.

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USP Suggests additional Testing for Visible Particles in Parenterals

A recently published article of the Pharmacopeial Forum (Vol. 35(5)) suggests additional testing of parenteral products. This testing is supposed to be conducted randomly according to the 100% control in the process and to substantiate the required "essentially free" of visible particles. Read on here.

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Sample Documents for Participants in the Seminar Validation of Analytical Test Procedures

Participants in the ECA event "Validation of Analytical Procedures" in Copenhagen from 13-15 October receive concrete examples in the form of a brochure as part of the event documentation.

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Personal Liability of the Qualified Person and Possibilities for Insurance

Discussions of a QP's liabilty and possibilties for insurance can be heard everywhere. Read more about the things that need to be considered.

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Dutch Medicines Authority Takes Measures after CEP Suspension by EDQM

The EDQM suspended CEPs of an Indian manufacturer of active pharmaceutical ingredients on the grounds of GMP deficiencies in manufacture. Subsequently, the Dutch medicines authority removed the manufacturer from the authorisation files with the substances in question. Read more here.

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Pharmaceutical Aspects of Product Information - EMEA publishes Concept Paper on a Guideline Revision

The EMEA published a concept paper for the revision of the "Guideline o the Pharmaceutical Aspects of the Product Information for Human Vaccines". Read more here.

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Supplier Qualification more and more in the Focus of Authorities

The authorities place increasing emphasis on the continuously growing challenges of the global supply chain and its supervision. Read more about the expectations of the FDA and of the European authorities.

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Quality Agreements for Excipients - Indispensable for a Transparent Supply Chain

The supply chains for excipients stretch around the entire globe. This makes it all the more important for the excipient-sourcing and -processing companies to secure these supply chains among other things with correct and complete quality agreements. IPEC Europe has published a new guideline on this subject. Read the details here.

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CBER: Vaccines, Blood and Biologics - Exception or alternative Procedures

FDA's Center for Biologics Evaluation and Research (CBER) published a list of  exceptions or alternative procedures approved under 21 CFR 640.120. Please read here for more details.

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EMEA publishes Guideline on Investigation of Medicinal Products in the Term and Preterm Neonate

The Guideline which will become effective on 1 January 2010 addresses the considerations and requirements for the design and conduct of clinical trials in premature and term neonates using medicinal products of relevance for the use by this population. Read more.

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USP <1235> Vaccines for human Use - general Considerations

The US Pharmacopeia (USP) published a new general chapter <1235> Vaccines for Human Use - General Considerations in the section In-Process Revision. It provides background information on manufacturing and tests of vaccine monographs. Read more here.

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New EMEA Q&As on ICH Q8, Q9 and Q10

Topical questions and answers on ICH Q8, Q9 and Q10 were published by the EMEA at the end of June. With this document, the requirements laid down in the three guidelines are meant to be implemented and interpreted in a harmonised way in the three ICH regions. This link will lead you on.

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FDA prepared to act more aggressively

On 6 August 2009, FDA Commissioner Dr Margaret Hamburg talked about FDA's visions and future measures in order to better ensure the protection of public health. Read more here.

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