GMP NEWS 2017

Serious FDA Warning Letter issued to European Manufacturer of sterile Drugs, Part 2

As a consequence of significant GMP violations, the US-American FDA issued an unusually serious Warning Letter to a Hungarian company on 13 October 2016. Serious also because the authority put this company on import alert until the violations are corrected. Learn more on the 2016 FDA Warning Letter to Teva Pharmaceutical Works Private Ltd.

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GMP Outlook for 2017 (Part 2)

There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.

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ICH Plan to Modernise Global Good Clinical Practice Guidance - "GCP Renovation"

The ICH recently published a reflection paper on “GCP Renovation” regarding the modernization of ICH E8 (General Considerations for Clinical Trials) and the subsequent renovation of ICH E6 (Guideline for Good Clinical Practice). Read more about ICH´s Reflection Paper on the potential renovation of the ICH guidelines related to clinical trials.

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Once again Critical Inspection Findings at two Indian Study Sites

Critical violations in view of the inspected studies as well as serious deficiencies in the quality management system of two Indian study sites were found during GCP inspections. Read more on the findings of the GCP inspections conducted at two Indian Sites.

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FDA publishes Q&A Paper "Use of Electronic Informed Consent"

The U.S. Food and Drug Administration (FDA) recently published a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigation. Read more about the FDA Guidance "Use of Electronic Informed Consent Questions and Answers".

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Increasing Number of GDP Non-Compliance Certificates

The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. From January 2016 until today six GDP non-compliance reports have been published. Please read more about the GDP Non-Compliance reports.

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A 12 steps guide on how to choose the right Third Party Logistics (3PL) provider

Having in mind a proper needs assessment  many companies in the field are considering the outsourcing of their logistic activities. But when it comes to the decision making definite decisions are required. Support provides a 12-steps guide for the outsourcing of logistics activities.

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The Qualified Person: also responsible for Distribution Activities?

In his talk on "Detection of Falsified Medicines and how the QP can support this", Paul Hargreaves (MHRA), explored some facts that a QP should know when it comes to the falsification of medicines.

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Do you know the Saudi GDPs? And the Role of the Responsible Person?

The GDP Guidelines of the Saudi Food & Drug Authority (SFDA) have been published in English and are similar to those in the EU. But there are also some differences between the Saudi and the European GDP Guidelines.

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GMP for ATMP - two Public Rounds of consultation and still a Need for Discussion?

After the second public consultation for the EMA Guideline on GMP for Advanced Therapy Medicinal Products there are still uncertainties and a persisting need for discussion of the current regulatory requirements.

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Interesting Analysis of GMP Inspections published

The British MHRA has published the 2015 GMP inspection deficiency data trend. The report lists examples for all relevant chapters and annexes of the EU-GMP Guidelines.

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Is Senior Management really responsible for GMP?

Yes, it is! As you can see in a recent case from Denmark, where the Danish Medicines Agency requires that the CEO of a repackaging facility needs to be replaced.

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Revised USP Chapter <1058> on Analytical Instrument Qualification

The USP has released a revision of Chapter <1058> on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory. Get more information on the new USP Chapter <1058>.

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Stimuli article on the proposed USP General Chapter <1220> published in Pharmacopeial Forum

A Stimuli article on the proposed new USP General Chapter <1220> has been published in Pharmacopeial Forum 43(1) [Jan.-Feb. 2017]. Read more about the "The Analytical Procedure Lifecycle".

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FDAs Draft Guidances of Compounding and Repackaging of Radiopharmaceuticals

The FDA published two draft gidelines on their current thinking on Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies as well as by outsourcing facilities.

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3R - European Medicines Agency's Activities in Replacement, Reduction, Refinement of Animal Testing

The EMA published a refelection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs. It is part of the EU strategy that principles of Replacement, Reduction and Refinement must be considered systematically at all times when animals are used for scientific purposes in the EU.

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Draft USP Chapter <671> Containers - Performance Testing

A draft version of general chapter <671> Containers—Performance Testing has been recently published in the Pharmacopeial Forum - and is open for comments until end of March.

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FDA publishes Final Guideline on GMP for Combination Products

In the beginning of 2015 the FDA has published a draft guideline about GMP for Combination Products. Now the final version has been published. What are the differences between the draft and the final version of the FDA Guideline for Combination Products?

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EMA publishes Q&A on Health Based Exposure Limits - Does the 1/1000 dose criterion come again into play in Cleaning Validation?

In 2014 the European Medicines Agency (EMA) issued the Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. This publication triggered a discussion about the Permitted Daily Exposure (PDE) values in the Pharmaceutical and even in the API Industry, especially regarding crosscontamination and cleaning validation. Now a draft of a Q&A paper from the EMA provides some concretisation.

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New FDA Warning Letter for Wockhardt, Ltd. in India

The manufacturer of APIs and medicinal products Wockhardt in India received an FDA Warning Letter at the end of December 2016. During the inspection, it had been observed that both in GC and HPLC analytics OOS results were excluded from the official records. Get more information about the current Wockhardt FDA Warning Letter.

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