GMP NEWS 2016

GDUFA: FDA's new Guidance on Self-Identification of Generic Drug Manufacturers

FDA's new Guidance requesting generic drug manufacturers who want to export to the USA to self-identify has recently been published in a finalised form. Read more here about what types of generic drug manufacturers are affected and which company data are required by the FDA.

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USP announced Major Revision of General Chapter <1217> "Tablet Breaking Force"

The United States Pharmacopeia (USP) Expert Committee on General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force <1217>. Comments can be submitted until October 15, 2016. Read more about the planned revision of USP general chapter <1217>.

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New MEDDEV Document on the Clinical Evaluation of Medical Devices

To put the EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC" has been newly published. Comprising 65 pages, the document is very extensive and describes requirements for the clinical evaluations of medical devices in Europe.  

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WHO publishes Second Draft of a Global Medical Devices Regulation

With a draft document made up of 66 pages, the WHO intends to provide support regarding the introduction and implementation of regulations with regard to medical devices, including in vitro diagnostic medical devices (IVDs). The document is a revised draft whose first version - however - hasn't been published. The document history shows that the revision had become necessary as the first draft was too complicated. What does the second draft contain?

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MHRA publishes Draft Guidance on "Usability" of Medical Devices

With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products - particularly with regard to the increasing complexity of these products. Find out more about the MHRA's expectation for medical devices and combination products in terms of design process.

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EMA recommends stopping the Supply of Medicines manufactured at U.S. Company

The EMA has recommended that medicines manufactured by the U.S. company Pharmaceutics International Inc. should no longer be available in the EU. This follows the issuance of two Non-Compliance Reports for two sites of the US based company.

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Is Cost Pressure becoming the Main Reason for GMP Non-Compliance and Drug Shortages?

It has been a hot inspection summer. FDA Warning Letters and EU Non-Compliance Reports seem to increase at the moment. It is worrying that the GMP non-compliance issues apparently get more serious than in the past. But what is the reason for the increasing GMP non-compliances?

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Current Considerations on Pharmaceutical Water Systems and Ozone

In pharmaceutical water systems, ozone is an effective method to keep microbiological contamination under control. In the course of cold production (and storage) of WFI, which will be allowed as of April 2017, ozone will play an even bigger role.  When ozone is being used to sanitize a piping system, its effect has to be verified. Learn more about the classification of Ozone Measurement in Piping Systems.

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Annex 17 on Real Time Release Testing: Results of Public Consultation

Last year, a public consultation was launched on a draft revised Annex 17 on Real Time Release Testing. Deadline for comments was 11 December 2015. Now, the feedback from the various stakeholders was published.

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Current Status of GDP Implementation and the Role of the RP - an Overview

To find out where the EU GDP Guidelines have been implemented already as a national rule ECA's GDP Working Group set up a survey amongst its members. Here is a summary of the feedback.

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Danish Manufacturer receives a so-called Untitled Letter from the FDA due to Deviations from GMP

A Danish pharmaceutical manufacturer has received a so-called "Untitled Letter" from the FDA after an inspection at his production site in Denmark. The letter was issued because of deviations from diverse GMP rules. Read more about the definition of an Untitled Letter and the GMP violations identified.

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FDA´s New Regulations for Drug Manufacturers

The US Food and Drug Administration (FDA) finalized its revised regulations governing drug establishment registration and drug listing. Read more about the requirements for foreign and domestic establishment registration and listing for human drugs, including drugs that are regulated under a biologics license application, and animal drugs.

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GVP Update

With this news we inform you about recent developments concerning EudraLex Volume 9 - Guideline on good pharmacovigilance practices (GVP). Read more about the revisions of GVP Module VI and IX (including Addendum) and published finals of GVP Module VIII and P.II on biological medicinal products.

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Revised Recommendation related to Transmission of Zika Virus

Relating to the fast developments in Zika Virus transmisions, the FDA now published a guidance for Industry with Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.

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FDA Guidance on Determining Donor Eligibility for Autologous Donors of Blood and Blood Components

In addition to the existing guidance on donor eligibility, the FDA published a new guidance document on " Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use"

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Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

The US Foood & Drug Administration (FDA) published an Draft Guideline on the Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products.

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Analytical Lifecycle: USP <1210> "Statistical Tools", Analytical Target Profile and Analytical Control Strategy

The United States Pharmacopeia (USP) is currently undertaking further steps towards a comprehensive analytical lifecycle approach by publishing a draft of a new General Chapter <1210> Statistical Tools for Procedure Validation and two Stimuli Articles regarding Analytical Target Profile and Analytical Control Strategy in Pharmacopeial Forum. Read more about the life cycle concept for analytical procedures.

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Warning Letter to a British Manufacturer: Cross Contamination, Pharmaceutical Water and Particles

The US Food and Drugs Administration (FDA) has issued a Warning Letter to a British API manufacturer. They criticized cross contamination by penicillin products, deviations regarding pharmaceutical water and foreign particles in the product. Read more about the major deviations in this Warning Letter.

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New Warning Letter of the FDA with the Focus on "Data Integrity"

The FDA has set the focus of its inspections on data integrity for quite some time already. The most recent Warning Letter addressed to a Chinese API manufacturer dated August 2016 clearly concentrates on the topic data integrity. Please find out more about the current FDA Warning Letter in this News.

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New Q&A Document on the Visual Inspection of Parenterals available

The ECA's Visual Inspection Group has developed a new document with answers to frequently asked questions. This new Q&A document is now available for download on the Group's website. Read more about frequently asked questions in the visual inspection.

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