GMP NEWS 2012

Novel Manufacturing Strategy: Continuous Manufacturing - Development Case Study

The pharmaceutical industry is still dominated by 'frozen' batch processes with little, if any, automatic feedback control. Time is now for the pharmaceutical industry to evolve from the 'frozen' batch manufacturing process characteristic to automatic controlled continuous manufacturing in the future. Please find more information in this news, dealing with an article from Prof. Dr. Fernando Muzzio about the development of continuous manufacturing processes for the manufacture of pharmaceutical tablets.

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New Templates for GMP and GDP certificates published by EMA

In May 2012 and in July 2012 the European Medicines Agency (EMA) revised the Compilation of Community Procedures on Inspections and Exchange of Information. Read more here.

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Continuous Manufacturing - FDA Perspective on Submissions and Implementation

From FDA's point of view, the science exists to enable continuous manufacturing in the pharmaceutical industry and there are no regulatory hurdles for implementing it. However, there is a lack of necessary experience. Read more in this News.

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Curved Calibration Functions - how to perform the Regression Calculation?

For curved calibration functions there exists some uncertainty how to establish a calibration which is in conformity with DIN/ISO standards. In this news you will be informed about new possibilities for performing the corresponding calculations.

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FDA Expectations concerning Real Time Release Testing (RTRT)

The FDA has highlighted the importance of Real Time Release Testing (RTRT) in a publication. It explicitly supports the implementation of RTRT approaches in the pharmaceutical industry.  When RTRT is used, it is part of the control strategy and can include some or all of the final critical quality attributes (CQAs). Please click here to obtain more information in this news.

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New EMA draft on NIRS

The EMA has published the draft for a Guideline on the use of Near Infrared Spectroscopy (NIRS) in January 2012. NIRS is one of the most important technologies in PAT applications. The guideline deals with qualitative and quantitative procedures. You can obtain more information in this news.

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USP Article about new USP NIR System Suitability Reference Standard

In an article of the USP Pharmacopeial Forum, the authors give reasons why the continued use of the USP NIR System Suitability Reference Standard is recommended. More about the USP article and the verification of wavelengths of NIRS systems by calibration standards can be found here.

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New EMA Guideline on Real Time Release Testing

The concept of parametric release has been primarily used for the sterility testing of products terminally sterilised. Now, the new EMA Guideline will extend this alternative release strategy - Real Time Release Testing - to all types of APIs and finished products testing. Read more here in the News.

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FDA Warning Letters relating to Computerised Systems

Problems in connection with computerised systems have also been addressed in two actual FDA Warning Letters. Read more here.

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EMA publishes Video explaining the new Pharmacovigilance Legislation

The European Medicines Agency has produced a video with an introduction to the new pharmacovigilance legislation. Read more.

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New Rules for the Importation of APIs - a European Commission Leaflet provides Information

The new rules for the importation of active pharmaceutical ingredients will already enter into force next year. As of 2 July 2013 each consignment of active substances imported into the EU must be accompanied by a written GMP conformity certificate. The European Commission comments once again the most important questions concerning the written confirmation in an information leaflet. Read more here.

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Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board

Dr Claudius Micha Nübling from the Paul-Ehrlich-Institut became member of the RMM Group Advisory Board. He will follow our longstanding Member Dr Thomas Montag. Read more here.

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New Additions to the Literature List on ECA's RMM Website

The ECA Rapid Microbiological Methods working Group added new reports and articles to the literature list on its website . More can be found here.

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Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research

The FDA's CBER published their strategic plan for regulatory science and research 2012 -2016. A possible further step for implementation of modern microbiological methods? Read more.

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More Flexibility in Sterility Testing of biologic Products – FDA Amendments

Within FDA's scope - to review and, as necessary, update biologics regulations, to keep pace with technological developments and to boost regulatory science, the US authority published amendments to the sterility testing rule. Read more about the background and contents.

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Draft on New GCP Directive 2001/20/EG

The GCP Directive 2001/20/EG will be revised. The EU Commission has published a draft accompanied by additional documents. Read more here.

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EDQM publishes Guidance on Notifications of Changes of CEPs

The EDQM has recently published a document intended as a guide for the renewal or revision of a certificate of suitability. The EDQM hopes that this will reduce the time needed for the procedure and limit requests for additional information from CEP holders. Read more about this very helpful document here.

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GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress

As of 1 October 2012, the FDA can collect fees from generic drug companies for the processing of marketing authorisation applications.The authority can further collect fees for the performance of inspections of generics manufacturers and API suppliers of the generic industry. The reason for this is the enactment on 9 July of the "Generic Drug User Fee Act" (GDUFA) by the Congress. More details about the new act can be found here.

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ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products

Recently, the European Medicines Agency published an Reflection Paper on classification of advanced therapy medicinal products. This document is open for consultation until 31 July 2012. Read on.

 

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Revised Guideline on Renewals in the Centralised Procedure Effective!

On 2 July 2012, the revised guideline on renewals in the centralised procedure came into force. Against the background of the Variations Regulation and the new provisions regarding pharmacovigilance, the guideline has been significantly revised and contains new requirements. More details here.

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