GMP News

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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Is there anything like European Warning Letters?

European Warning Letters? Is there such a thing? Basically, no. Warning Letters are issued by the US-American FDA. However, there is something "comparable" namely the "Non-Compliance Reports" published in the Eudra GMDP database. Now, one may question what the authorites has complained about in the last 3 months.

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cGMP Qualification/Running of Water Systems

Water systems are one of the most important systems in the pharmaceutical industry. What are the GMP requirements for the qualification and running of these systems? The US GMP regulations (21 Code of Federal Regulation (CFR) 210/211) do not provide much concrete information on this. There is still a Guide to Inspection for FDA inspectors from the early 90s. So, what does the FDA expect today? A current Warning Letter provides a few answers.

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Information on the Medical Devices Regulation

The application of the Medical Devices Regulation (2017/745, MDR) as of 26 May 2020 is approaching. Find out more about the MDR environment.

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How to authorize a Combination Product in the USA?

In the USA, combination products are regulated independantly.  A draft document from the FDA entitled "Principles of Premarket Pathways for Combination Products" describes the ways in which marketing authorisations are granted in the USA and how the various Centers interact.

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When does the FDA announce the Inspection of a Medical Device Manufacturer?

With the entry into force of the FDA Reauthorization Act (FDARA) in August 2017, sections on the inspection of medical device manufacturers in the USA and abroad also became effective. A draft document from the FDA on inspections of medical device manufacturers has been issued for some time now to further harmonize and interpret the changes.

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Guide on the Use of Type V Drug Master Files for Combination Products

In October 2019, the FDA issued guidelines in a draft document regarding the use of a Type V Drug Master File (DMF). In this document, information can be made available to the CDER (if it is in charge of the (project) approval procedure) concerning the medical device proportion of a combination product.

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PIC/S: How Inspectors should evaluate a PQS

The PIC/S has published a draft Recommendation on risk-based change management within the PQS.

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