GMP NEWS 2020

Update on the Implementation of USP´s revised Plastic Packaging Chapters

The United States Pharmacopeia recently posted an update on the delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>.

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USP Proposes New General Chapter <668> Cured Silicone Elastomers

The USP General Chapters—Packaging and Distribution Expert Committee is proposing a new general chapter <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components.

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Changes to Pharmacopeial Forum

The United States Pharmacopeia is currently introducing some changes to the format of the USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.

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Pilot Programme on GMP Inspections of Manufacturers of sterile Medicines

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use.

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Clinical Trials Regulation Questions & Answers Version 2.3

The European Commission (EC) published an updated Version 2.3 of the Questions & Answers relating to the Clinical Trials Regulation.

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FDA´s Advice for Sponsors of Adaptive Design Clinical Trials

The FDA published a new guideline on Adaptive Design Clinical Trials for Drugs and Biologics.

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ICH E9 Addendum adopted

The ICH E9(R1) Addendum to defining the appropriate Estimand for a Clinical Trial / Sensitivity Analyses reached Step 4 of the ICH Process.

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From GVP to GMP: MHRA´s tips for QPs to stay compliant

The MHRA recently posted three top tips for protecting patients and staying compliant when introducing updates to patient information leaflet.

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Endotoxin and Pyrogen Testing - Challenges for Biotechnological and Biopharmaceutical Products

The introduction of alternative methods as, e.g., the Monocyte Activation Test, is a challenge for many laboratories.

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Second Chapter of ECA's Microbiological OOS/OOL Guideline announced for May

The ECA's Pharmaceutical Microbiology Group has announced the second chapter of their Guideline on handling microbiological deviations for May. It deals with OOS/OOT and atypical results in endotoxin testing.

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EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs

A document on the topic of comparability in the context of Changes and Variations at ATMP, published in December by the EMA, respectively the CAT, completes the series of guidelines and assistance around ATMP.

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Report: Challenges with FDA Inspections

Report indicates persistent challenges and concerns with FDA foreign inspections.

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FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

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Warning Letter for inadequate OOS Investigations and Complaint Handling

The U.S. Food and Drug Administration (FDA) recently warned Teligent Pharma, Inc., for different significant violations of current good manufacturing practice (CGMP) at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate out-of-specification (OOS) test results.

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Risk Management Standard for Medical Devices ISO 14971:2007 revised

The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle. What is new?

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Warning Letter for not meeting FDA/USP Requirements

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).

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US Manufacturer of homeopathic Medicines and nutritional Supplements receives FDA Warning Letter

From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a Warning Letter from the FDA.

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Ph. Eur. Draft Chapter for PA Contaminants in Herbal Drugs

A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of  Pharmeuropa. The scope of this new general chapter covers trace analysis of target PAs in herbal drugs, herbal drug preparations and herbal medicinal products.

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