GMP News

Brexit: Pharmacovigilance Requirements for UK MAHs

The MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders.

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FDA Requirements regarding Quality Assurance

Many of the requirements laid down in the US-American GMP regulations (21 CFR 210/211) are not very specific. However, they are concretized among other things by Guidances - and by Warning Letters. Warning Letters in particular show very clearly how the FDA interprets its GMP regulations. A current Warning Letter provides information on the tasks of the Quality Assurance Unit.

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Inspection of biotechnological Manufacturers - PIC/S AiM Updated

In January, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-Operation Scheme (PIC/S) published a revised version of its Aide Memoire "Inspections of Biotechnology Manufacturers".

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FDA stops Hand Sanitizers with too low Alcohol Content at the US Border

The U.S. Food and Drug Administration (FDA) pays close attention to what is inside hand sanitizer products imported into the United States. Recently, a product labeled as containing 75% ethanol, but in fact contained only 58%, was detained and refused admission at the border. As a consequence, the Chinese manufacturer received a Warning Letter.

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UK Guidance on Limits for Controlled Cannabinoids in CBD Products

Extracts or isolates containing Cannabidiol are used in cosmetics and food supplements supplied to the UK market. One question still remains: How to interprete the 1 mg UK limit for controlled cannabinoids?

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Can the Water Activity Test replace Microbial Testing?

According to the USP no microbiological testing of low water activity pharmaceutical products may be needed after a comprehensive risk assessment. The USP therefore revised the general chapter <1112> Role of Water Activity in Microbial Risk Assessment of Nonsterile Pharmaceutical Products.

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FDA's Strategies for Bacterial Safety of Platelets

In December, the FDA updated its guidance on bacterial safety strategies for platelets and platelet preparations, particularly in light of the current implementation difficulties faced by facilities under pandemic conditions.

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25 Years Alternative Pyrogen Testing: Where do we stand? A Retrospect and Outlook

The EU demands to reduce animal testing or to avoid it altogether wherever possible. The pyrogen test on rabbits is therefore being replaced by MAT as an alternative in the EU. But how long has this taken and where is the journey going for alternative test systems in microbiology? A short review and outlook can be found here.

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EMA Clarifies GMP Requirements for Herbal Substances Used as APIs

When does EU GMP Guide Part II apply to the manufacture of herbal extracts? A new EMA Q&A document on GMP for herbal extracts used as active substances in herbal medicinal products gives the answer to this question.

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GAO criticizes FDA's current Inspections Approach

In a report published end of January, the U.S. Government Accountability Office (GAO) asks the US Food and Drug Administration (FDA) to review its inspections approach during the pandemic.

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Brexit Guideline from CMDh updated

The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit.

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FDA Applications during Covid-19: better Communication planned

With an updated Guidance document, the US Food and Drug Administration (FDA) plans to improve communication with industry.

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EMA: Revised Q&A Document for Centralised Procedures

The "Q&A" document for centralised marketing authorisation procedures, focusing on questions and answers on topics that marketing authorisation holders should consider after obtaining a marketing authorisation, was revised again and published on the EMA website in February.

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Updated Guidance on the Management of Clinical Trials during COVID-19

Pragmatic procedures are currently required to ensure the flexibility needed to maintain the integrity of clinical trials during the COVID-19 pandemic. The updated guidance on management of clinical trials during COVID-19 includes adapted approaches for IMP supply and details on remote source data verification.

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Updated Timeline for the Clinical Trial Regulation

The EMA is still planning with December 2021 as the date for the first application of the Clinical Trial Regulation (CTR). Initial information on the schedule was published in December.

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Insufficient Quality System leads to GDP Non-Compliance Report

Wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirements. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example entered into the EudraGMDP database by the Romanian authority shows.

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FDA Plans for new (GMP) Guidance in 2021 - CDER provides Information

What are the FDA's plans regarding new guidances for the calendar year 2021? An answer to this question is provided by the Center for Drug Evaluation and Research (CDER) in their list of planned and / or to be revised guidance documents. On five pages, comprising 18 individual categories, these documents are presented.

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Questions & Answers on Good Distribution Practices (GDP) - Part 1

In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 1 deals with questions related to GDP training.

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Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor

The competent authority of Czechia has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the fact that a Czech wholesale distributor does not provide approved storage facilities.

 

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CAT - Monthly Report on ATMPs

A regular insight and overview of the activities around ATMP in Europe is provided by the reports on the CAT meetings, which list the latest news on classification, authorisation and much more.

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FDA - Testing of Cells and Tissues Donors for Transferable Diseases

As a complement to the many guidances and documents on the development and manufacture of products from human cells and tissues, the FDA also provides an overview of strategies and approved tests for microbiological testing of donors of cells and tissues.

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Modern Vaccines and Platform Technologies - Explained in an Understandable Way

Questions reaching us on the subject of COVID-19 vaccines, their development, approval and production, and on modern platform technologies used are answered in a summary.

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EU plans new Health Authority

The European Commission is planning to create a new EU Health Emergency Preparedness and Response Authority (HERA). For this purpose, the Commission has opened a feedback procedure.

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PMDA publishes Remote Inspection Guidance

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of a Procedure for Remote Inspections.

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Are QP Remote Certifications allowed?

We keep receiving questions about the extent to which remote QP certifications are possible in the current situation. Unfortunately, the legislation in the individual EU Member States is not uniform.

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