GMP NEWS 2017

Draft DIN EN ISO Injection Vials made of Tubular Glass

The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment.

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A Message from the Ex-Chairman

Richard (Dick) Bonner became Chairman of the ECA Foundation as well as of the European QP Association in 2012. Now, after six years in these positions, he decided to step down. Please read his message from the Ex-chairman.

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GMP for ATMP - European Commission adopts new Guideline

On 22 November, the European Commission adopted the expected new "Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products" as the new stand alone document for the current requirements for authorised ATMP as well as for clinical trials.

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Track & Trace: New Questions and Answers published by the EU

The next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation.

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Warning Letter: fundamental GMP Deficiencies in API Production

Fundamental violations of GMP basics in the area of API production found in an official inspection usually lead to unpleasant consequences or, in case of FDA inspections, to a Warning Letter. Read more on which issues concerning in-process controls, documentation and OOS results are intolerable.

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Become an active part of the Conference "Particles in Parenterals"

The ECA Foundation's Visual Inspection Interest Group has been conducting the annual conference "Particles in Parenterals" for several years now. For the planning of the 2018 event you can become involved as an active part.

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And the EMA goes to ... Amsterdam

When Britain leaves the EU, the European Medicines Agency (EMA) will have to move as well. The final decision where to was made by drawing the name of the new EMA location out of a hat. How could that happen?

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USA: Track & Trace Realisation Postponed by a Year

In June, the FDA reported that the enforcement of requirements for the safety of supply chains will be postponed by a year. The new date is now November 27, 2018. Find out more about the change of the date in the FD&C Act.

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Data Integrity - Implementation status

Data Integrity deviations are still in the focus of regulators. Nevertheless you will find only general requirements regarding Data Integrity in the GMP Guidelines. More detailed guidelines on Data Integrity are on the way but mostly available as drafts. Get an overview on the current situation and the first implementation steps of Data Integrity activities. 

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GVP Update 2017

There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more about the revisions of several GVP Modules and the published draft of Product- or Population-Specific Considerations IV: Paediatric population.

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EudraVigilance: EMA's new Signal Management Guide

In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry.

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FDA's new Guidances on the Approval of Generic Drugs

The FDA has recently published various guidelines on application procedures for generics. Read here, which special requirements have to be met for the authorisation application of generics for the US market.

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Will FDA now stop conducting GMP inspections?

The European Medicines Agency (EMA) has updated its Q&A section on the Mutual Recognition Agreement. These questions mainly refer to the start of the operating phase of the MRA on 1 November 2017.

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Insufficient Media Fills in FDA Warning Letter

Insufficiently planned and performed media fills were at the centre of an FDA Warning Letter. Read more about the criticised deficiencies from a Warning Letter to the Korean manufacturer Firson Co., Ltd.

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Revision of the USP chapter on Raman

Raman is a technique often used for incoming API and excipients inspection besides IR and NIR. New suggestions for updating the chapter were published in the USP's Pharmacopeial Forum. Find more information on USP chapter <858> Raman Spectroscopy.

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The ICH E11 Addendum on clinical investigation in children now enters into implementation

The ICH E11 Addendum reached Step 4 of the ICH Process and now enters into the implementation period. Read more about ICH E11 Clinical Investigation of Medicinal Products in the Pediatric Population.

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EMA publishes Concept Paper on Guidance Development on non-clinical Evaluation of Radiopharmaceuticals

The European Medicines Agency (EMA) evaluated an additional use for guidance relating to non-clinical evaluation of radiopharmaceuticals and published a new concept paper on the development of such a guidance.

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Positive Balance for Implementation of the Falsified Medicines Directive

The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. Read more on the securPharm press release.

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MRA: FDA now recognizes EU Inspectorates in 8 of 28 countries

Since 1 November, the MRA has been in the operational phase. The FDA now recognizes EU inspectorates in 8 of 28 countries - the majority of countries is not yet recognized.

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Data Integrity from an Inspector's Point of View

Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more about an inspector's viewpoint on data integrity.

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