GMP NEWS 2017

Revision of Annex 1 "Manufacture of Sterile Medicinal Products" published for Comments

The European Commission has published their long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU GMP Guideline.

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Annex 13: Detailed Commission Guideline on GMP for IMPs published

The Detailed Commission Guidelines on GMP for IMPs have now been published as final in Annex 13 in EudraLex Volume 4.

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Now online: Draft ICH Q12

The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more about ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

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Draft EU Regulation on BPA in Varnishes and Coatings

Following the notified draft regulation published in 2016 the European Commission (EC) recently published a revised draft regulation on BPA. Read more about Bisphenol A in varnishes and coatings and plastics intended to come into contact with food.

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Changes in ECA Foundation and European QP Association Advisory Boards announced

With the resignation of Richard M Bonner as Chairman of the Advisory Board of both the ECA Foundation and the European QP Association (EQPA) the organsation has announced changes in the Advisory Boards of the ECA Foundation and the EQPA.

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Warning Letter on Combination Products 21 CFR 4

For several years, combination products have been regulated by 21 CFR 4 in the USA. In September 2017, the FDA issued a Warning Letter to a manufacturer of combination products. What did the FDA criticise?

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2017 Medical Devices Warning Letters Statistics

In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.

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New WHO Guideline for Medical Devices and IVDs

The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. What is the purpose of the document entitled "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices"? 

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New FDA Guideline on Product Classification - what is a Drug, what isn't?

The new FDA guideline titled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drugs, medical devices or other.

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Report of the GMP/GDP Inspectors Working Group published

The EMA's GMP/GDP Inspectors Working Group has published the 2016 annual report summarising its activities.

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USP <381> Elastomeric Closure for Injections

The USP General Chapters Packaging and Distribution Expert Committee recently posted the intent to revise General Chapter <381>. The Chapter currently includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018. Read more about the revision of Chapter <381> Elastomeric Closure for Injections.

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Media Fill issues cause Non-Compliance Reports for Spanish Manufacturers

During two inspections, the Spanish supervisory authority found major deficiencies from two Spanish manufacturers of sterile medicinal products. Learn more about the Non-Compliance-Reports.

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EMA publishes Concept Paper on Revision of the Guideline on Clinical Development of Vaccines

The EMA published a Concept Paper on the revision of the 10 years old guideline on clinical evaluation of vaccines, relating to the ongoing advancements in the field of vaccine development.

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EMA publishes first Guidance for Stem Cell Therapies in Animals

In June, the EMA published a new Q&A document on the sterility of allogenic stem cell therapies in the veterinary sector. It represents the first guidance document on this topic.

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GDP Issues cited in Non-Compliance Report

A new Non-Compliance Report for parallel import, repacking and distribution of pharmaceutical products was published on the EudraGMDP site.

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Will there be an ISO Standard for Refrigerated Parcel Deliveries?

The British Standards Institution (bsi), Group Japan, has developed a so called PAS (Publicly Available Specification) to specify requirements for temperature-controlled delivery services for chilled and frozen goods.

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Does FDA enforce GDP?

GDP Guidelines are certainly a hot topic in the EU and in WHO states. In the US, things are still developing but are getting more and more important, as the excerpts from recent Warning Letters addressing GDP isssues show.

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USP Stimuli Article: Proceedings of the Analytical Lifecycle Workshop 2016

The USP published a stimuli article containing the Highlights of the US Pharmacopeia (USP) and ECA Academy Workshop on the Lifecycle Approach of Analytical Procedures.

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Drug Safety: FDA´s new Draft Guidance Regarding REMS

The FDA recently published its new draft guidance on Risk Evaluation and Mitigation Strategy (REMS). Read more about Format and Content of a REMS Document.

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QP not present in Company: Prohibition of Supply

A new Non-Compliance Report was published on the EudraGMDP site leading to a suspension of the respective manufacturing authorisation.

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