GMP NEWS 2018

Management and control of biological raw materials - the EBE Concept Paper

Raw materials used in the manufacture of biopharmaceuticals may show highly different characteristics and risk potentials. Read here why and how risk assessments for raw materials must be performed and where practical advice therefore may be gained.

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FDA Warning Letter: Outlier Test inadequate for OOS Investigation

The API manufacture Zhuhai United Laboratories Co. Ltd. received a Warning Letter from the FDA in June 2018. The FDA criticized that the OOS results of assay determinations haven't been adequately investigated. According to the FDA, the sole use of outlier tests is not appropriate. Read more about FDA's Warning Letter to Zhuhai United Laboratories.

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Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place

You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.

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EU guidance for new Medical Device Regulation (MDR)

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.

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Borderline questions on medical devices

At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.

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Sponsor Oversight - Metrics & Case Studies

The overall responsibility for clinical trials lies with the sponsor. Whereas activities may be contracted or delegated, responsibility itself can not. Read more about metrics and case studies from GCP inspections with regard to sponsor oversight of clinical trials.

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What is required for electronic informed consent (eConsent)?

The MHRA released a joint statement setting out the legal and ethical requirements for documenting consent using electronic methods. Read more about the MHRA´s view of seeking consent electronically (eConsent).

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New defect Evaluation List for Moulded Glass out now

The brand-new 2018 edition of the Defect Evaluation List for Containers Made of Moulded Glass which includes an appendix with example pictures of specific defect characteristics is out now.

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EMA: Work on Annex 1 and Annex 21 will continue

Because of Brexit, the European Medicines Agency (EMA) further needs to reduce activities. However some EMA acitivities will continue as planned.

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Missing Investigation of OOS Results leads to FDA Warning Letter

The API manufacturer Keshava received a Warning Letter from the FDA in March 2018. During the inspection, it has been criticised that no corrective actions had been taken for Out-of-Specification results and that a few analyses missed complete data. Read more here about the FDA Warning Letter for Keshava Organics.

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Expectations of the British MHRA on Decontamination with Hydrogen Peroxide

Decontamination by means of vapour hydrogen peroxide is a well established procedure for isolators. Now, the question is what the expectations of the British Authority MHRA are with regard to sterilisation of direct and indirect contact parts in isolators. Andrew Hopkins - among others chairperson of the working group for the revision of Annex 1 - published his opinion on that.

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Viral Safety of Blood and Plasma - FDA Guidance on HCV Testing

FDA published their recommendations for further testing if the result of a donor screening test for antibodies to the hepatitis C virus (anti-HCV) came out positive. These recommendations may be found in the draft guildeline on "Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus".

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Revision: FDA Guideline on Adaptive Designs for Clinical Trials

In September, the US Food and Drug Administartion published a draft guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics. It is the revision of the existing guidance from 2010.

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FDA Guidance on Efficient Clinical Trial Design Strategies for Cancer Drugs and Biologics

Relating to the increasing need of simultaneously evaluatation of more than one investigational drug and/or more than one cancer type in one clinical trial, the FDA published a new guidance on Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.

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Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers

The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.

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Single-Dose, Multiple-Dose or Single-Patient-Use Container?

The FDA published a new guideline on the selection of the appropriate package type terms and recommendations for labeling injectable medical products packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.

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Brexit: Insulin Stockpiles are built up

Pharmaceutical companies have started to build up stockpiles of lifesaving medications to be prepared for a hard Brexit.

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USP Stimuli Article on the Correct Use of Mean Kinetic Temperature

Recording temperatures during transport of pharmaceutical products as well as calculating the mean kinetic temperature is essential for assessing a batch with regard to its quality status. How to avoid mistakes when calculating the mean kinetic temperature?

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EMA clarification on the download of SARs from EudraVigilance

Due to inquiries concerning the handling of ICRs in EudraVigilance, the EMA has published a brief and structured clarification.

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What to expect from GVP inspections?

The MHRA recently updated their Good Pharmacovigilance Practice (GVP) webpage on the MHRA website. In addition, the agency provided important things to know about GVP inspectors and GVP inspections.

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