GMP NEWS 2014

QP Declaration: EMA publishes Comments

Three months after publication of the final QP Declaration Template, the comments from the consultation phase have been published. The answers to these comments also give some useful background information on EMA's expectations. Read more.

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How to identify Out-of-Trend Results in Stability Studies?

Different methods for the identification of OOT results in ongoing stability studies have been described in a PharmTech article. The conclusion is that there is an enormous need for a regulation with regard to this topic. More information can be found in the News.

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WHO publishes New Version of the Draft on "Hold-Time" Studies

In August, the WHO published the third revision of the draft guidance document on the design of hold-time studies. In many parts, the new version has become much clearer than the previous version. Read more.

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New GMP Non-Compliance Reports available in EudraGMDP

Last month, new GMP Non-Compliance reports were issued for three pharmaceutical companies. The facilities concerned are located in India, Taiwan and Bulgaria. Read more about these new GMP Non-Compliance Reports.

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FDA analyses Warning Letters with regard to Medical Devices

The ECA annually provides an analysis of the Warning Letters issued by the FDA with regard to medical devices. The analysis is based on the Warning Letters published over a fiscal year (from 1st October to 30 September). The FDA has published its own 2012 fiscal year overview. Read more. 

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Complaints and Recalls: new EU-GMP Chapter 8 published

The European Commission has published the final Chapter 8 of the EU Guidelines for GMP (Complaints, Quality Defects and Product Recalls). The chapter has been revised completely. Read more.

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If a Facility stores Medicinal Products for more than 36 Hours GDP will apply

Since the EU Good Distribution Practice (GDP) Guide has been revised, a number of questions regarding its interpretation have been raised. One of these questions relates to storage facilities and so called distribution hubs. The MHRA has provided guidance on this question. Please read more about the MHRA's interpretation of GDP.

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FDA publishes ICH Q4B - Annex 6 on Uniformity of Dosage Units

The ICH Guideline on Uniformity of Dosage Units was published in June 2014 by the FDA and thus became effective in the USA. More information can be found here.

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India blocks further Expansion of the ICH Harmonisation

India blocks the further expansion and therefore the success of the International Conference on Harmonisation (ICH). This is all the more surprising as the ICH is a unique success story. Read more.

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Is there something like Authorities' approved production equipment?

Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. Get the answer here.

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Immunogenicity Assessment for Therapeutic Protein Products

Related to the possible risks of immunologically based adverse events, the FDA published a "Guidance for Industry Immunogenicity Assessment for Therapeutic Protein Products". Read more here.

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Updated FDA Guidance for Donor Questioning related to Transfusion-transmitted Malaria

Beginning of August, the FDA published an updated version of their "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria". It supersedes the guidance with the same title dated August 2013. More about the changes can be found here.

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Revision of Classification of Advanced Therapy Medicinal Products

The European Medicines Agency’s Committee for Advanced Therapies (CAT) has revised a reflection paper on the classification of advanced-therapy medicinal products (ATMPs) to reflect cases in which medicines can be classified as ATMPs. Read more.

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Commentary Regarding new USP Chapters <787> and <1787> for Particulate Matter Guidance

There are new chapters in the USP regarding testing of subvisible particles. Chapter Subvisible Particulate Matter in Therapeutic Protein Injections <787>  became official August 1, 2014. The informational chapter <1787> was developed to support chapter <787> and will be published in USP 38 in November and become official on May 1, 2015. Read more.

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What is the difference between OOS / OOE / OOT?

In the meantime - beside OOS results - the terms OOE and OOT have become more and more frequent. But what do those abbreviations mean? How to implement the handling of OOS, OOE and OOT results in practice? More information can be found here.

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Still a GMP problem? Or already a criminal act? Do we need more stringent measures and enforcement in certain situations?

Sometimes EU and FDA Inspectors discover serious GMP deviations and fraud during an inspection. What are the consequences and do we need to think about additional measures? Please read more in our GMP News.

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Current FDA's Warning Letters on IT Topics - Part 2: Finished Medicinal Products and APIs

In cases of serious deviations from the GMP requirements, the US FDA issues Warning Letters to the companies concerned. In some current Warning Letters from 2014, significant GMP deficiencies with regard to IT topics can be found. Read on.

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What's new from the FDA regarding Medical Devices?

What is new in terms of FDA Guidelines or Draft Guidelines regarding medical devices? To find a selection from the last 6 months please read on.

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What's new from the IMDRF (the successor organisation of the GHTF)?

At the end of 2012, the International Medical Devices Regulator Forum (IMDRF) replaced the  Global Harmonisation Task Force which had been in charge until then of the worldwide harmonisation of requirements for medical devices. Read more about the current stand of IMDRF's publications. 

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Risk Management SOP Example for all Delegates of the ECA Course GMP for Medical Devices

All delegates of the ECA Course "GMP for Medical Devices" from 1-2 October 2014 in Heidelberg, Germany will receive a 17-page documentation with an FMEA SOP in English as well the associated FMEA form. Find out more about the free of charge add-ons.

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