GMP NEWS 2013

FDA plans significant increase of GMP Inspections in China

For quite some time, the US FDA has elaborated concrete plans to increase the number of inspections in China. These plans were developed as a consequence of the Heparin crisis. Based on a new agreement with China, the US FDA will now increase the number of inspections significantly. Read more.

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New Developments in the EU with regard to Medical Devices

After the "PIP scandal", the EU had announced a reform of the medical device regulation. Proposals were published in October 2012. Now, there are further developments. Read more here.

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New USP Requirements for Pharmaceutical Packaging Materials and International Standards for the Measurement of Material Permeability Indexes

This year, the USP has already published many new requirements for pharmaceutical packaging systems in the Pharmacopeial Forum (PF). Some of the most important new proposals in the USP are summarized in this news. In addition you can read about recognised standards (ISO, ASTM, etc.) for the testing of permeability properties of packaging materials in this news.

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ICH reviews future ICH topics and its Organisation

The results of the International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) meeting in Osaka, Japan have been published. Read more.

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New GDP Guide available in 22 different languages

The Good Distribution Practice Group (GDP Group) has summarized all language versions of the new GDP Guide. Please click here for more information 

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FDA: Draft Guidance for Industry: Donor Testing for Evidence of Infection with Treponema pallidum (Syphilis)

With the Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis), the FDA provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. Read more.

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FDA Science and Research: Keeping stored platelets free of bacteria

Scientists at the US Food and Drug Administration (FDA) have demonstrated in animal studies a proof-of-concept approach that might reduce the bacterial burden of room temperature stored human platelets. For more details read here.

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Recommendations for Premarket Notification Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation

Most cells of the body bear human leukocyte antigens which allow the human immune system to distinguish the body’s own blood, organs and tissues from foreign substances. Related to test kits for these HLA, the FDA published a Draft Guidance with recommendations for premarket notification submissions. Read more here.

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Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8

The EU Commission published the responses to the public consultation of 4 revised chapters of the EU GMP Guide. Read more.

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Revision of Annex 16: Results of Public Consultation

The responses to the public consultation on the revision of Annex 16 (Certification by a Qualified Person and Batch Release) have been published. Read more.

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Risk Assessment for ascertaining GMP for Excipients

The EU has published the comments received from the industry regarding the publication of the draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. Please click here to read more

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Guidelines on GDP revised

Only eight months after their publication, the Guidelines from 7 March 2013 on Good Distribution Practice of Medicinal Products for Human Use have been revised. Read more.

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FDA Warning Letter Statistics 2013 with regard to Process Validation / Qualification / Calibration

In previous GMP News, we presented FDA "Findings" in the complex topics validation / qualification / calibration in manufacturing with regard to medicinal products. Read the News to get the analysis of the 37 Warning Letters.

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Deviations in Packaging are increasing

Packaging defects are a key problem of the pharmaceutical industry. According to assessments by the FDA and the Irish Authority, as reported by International Pharmaceutical Quality (IPQ), the number of deviations and observations made on packaging & labeling has been steadily growing - partly in a drastic way. Read more here.

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FDA publishes Guidance for Industry on "Investigation Device Exemptions (IDE)"

On 1st October 2013, the FDA published the final version of the Guidance for Industry and FDA-Staff on "Investigation Device Exemptions (IDEs) for Early Feasibility Medical Devices Clinical Studies Including Certain First in Human (FIH) Studies". The document is composed of 40 pages, which ... Read more here.

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FDA will participate in a Medical Devices Single Audit Pilot Programme in 2014

At the beginning of 2014, the FDA will participate in a pilot programme on MDSAP together with the respective monitoring authorities in Australia, Brasilia and Canada. Read more here.

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What's the News from the FDA regarding Medical Devices?

In irregular intervals, the team of CONCEPT HEIDELBERG publishes overviews over new FDA's Guidelines or Draft Guidelines regarding medical devices. In the following, you will find a selection from August/ September/ October. A new ... Read more here.

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New system added - Rapid Microbiological Methods Database updated

The Rapid Microbiological Methods database in the member area of our working group was once again updated with new systems. Find out more.

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NAT Testing of West Nile Virus from Human Cells and Tissues

As a part of their continuous review of new data related to West Nile Virus, the FDA published a Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Read more.

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