GMP NEWS 2011

EMA Reflection Paper on risk based Quality Management in Clinical Trials

The European Medicines Agency EMA has recently released a draft reflection paper on risk based quality management in clinical trials. Read more.

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EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures

The EMA has recently published two documents concerning the centralised application procedures for new, generic and hybrid medicinal products. How useful these documents are and where to find them can be read here.

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ICH Q4B - Annex 7(R2) on "Dissolution Testing" becomes binding in the USA too

The second revision of the ICH document on Dissolution Testing for the comparability of pharmacopoeial texts in Europe, USA and Japan was published in June 2011 by the FDA. One of the aims of this guideline is to avoid redundant investigations by the pharmaceutical industry. Read more here.

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FDA criticises SOP Training in pharmaceutical Companies

Reviewing FDA's warning letters of the last fiscal year reveals that management and training of Standard Operating Procedures (SOPs) is still a hot topic. Read more.

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New: Revised USP Monographs of Spectroscopic Methods

Six updated chapters about AAS, IR and UV-Vis were published in the Pharmacopeial Forum from September 2011. The USP will replace the existing Chapter <851> with this group of topics. You will find more details here.

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EDQM gives Clarification concerning Stability Data for APIs within the Certification Procedure

The Guideline "Stability Testing of existing active substances and related finished products" (CPMP/QWP/122/02 rev1 corr) provides information about stability data required in a marketing authorisation dossier for monographed and non-monographed APIs. As the obligations of the API manufacturers hadn't been very clear, the EDQM decided to provide clarification. Read more.

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Expiry Dating for Reagents and Solutions in Laboratories: What are FDA's Expectations?

The FDA has published a Q&A document regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents and mobile phases in laboratories. Read the full news here.

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Faster Sterility Tests for Biological Products

The FDA published a scientific poster on "Identifying faster Sterility tests for Biological Products - Regulatory Research Seeks to Reduce the Time Needed to Ensure the Safety of Critical Products". Read more.

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Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science

In August, the FDA published a Strategic "Plan to Advancing Regulatory Science at FDA". This plan includes statements to amend microbial safety of products with modern microbiological methods. Read more.

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Revision of USP 231 "Test for metal Catalysts" - what will change?

Because of recent toxicological data, the detection and quantification of metal impurities in medicinal products and food supplements is of considerable importance. The methods described in the USP don't meet the current state of technology and are being revised. What changes can be expected in the new USP chapters <232> and <233> and what will be the consequences for the QC laboratories can be read here.

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German Initiative 2D Matrix Code SecurPharm started on 31 August!

On 31 August 2011, the initiative SecurPharm - developed by the organisations BAH, BPI, VFA, Pro Generika, PHARGO, and ABDA - started. 270 specialists and managers from the pharmaceutical industry met at the Jahrhunderthalle in Frankfort. Read more here.

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European QP Association forms Expert Panels

After the first five successful years of its existence, the European Qualified Person Association (EQPA) decided to develop a new structure and to integrate more colleagues into its activities. Read more.

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EMA Reflection paper on IVR/IWR systems

The intent of this draft paper is to provide guidance to the sponsors and to the IVR/IWR providers. Read more.

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USP and FDA strengthen Collaboration

To strengthen their collaboration, USP and FDA signed a 3-year agreement. In concrete terms, 40 chemical reference standards should be jointly controlled by them. Read more here.

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FDA withdraws Guideline on Validation of LAL Test

On 12 July, the FDA withdrew the Guideline on  "Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human Parenteral Drugs, Biological Products, and Medical Devices" from 1987. Read on.

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Report on the joint Good Clinical Practice (GCP) Inspection Pilot Programme

The report on the joint good clinical practice (GCP) inspection pilot programme details the success of information-sharing and collaboration on inspections relating to clinical trials. Read more.

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FDA Courses and Tests now available online

The organisation and the regulations of the US Food & Drug Administration (FDA) are frequently considered hard to comprehend. With regard to medical devices the CDRH runs a quite detailed website. Read more.

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Result of EDQM Expert Meeting on Manufacture of WFI by Membrane Process

In March 2011 the EDQM had invited experts from the pharma industry and water system suppliers to a workshop to discuss the possibilities for an approval of the membrane process for the manufacture of WFI in the European Pharmacopoeia. The report of the results is now available. Please read on here.

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EU GMP Guide: New Requirements added for Batch Certification

In Part III of the EU GMP Guide, a document on internationally harmonised requirements for batch certification has been added. Read more.

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FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications

End of July, the FDA published a draft on the documentation of medical device modifications. Read more about the 26 pages document here.

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