GMP News

Patient Safety Still the Main Reason for Reporting of Serious Breaches

The annual metrics report for GCP referrals has been published by the MHRA. In 2019, the MHRA received a total of 112 serious breach notifications.

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Herbal Drugs: USP Proposes New General Chapter on PAs

USP´s Expert Committee for Botanical Dietary Supplements and Herbal Medicines proposes a new general chapter on Pyrrolizidine Alkaloids (PAs).

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New Post in the MHRA Inspectorate Blog on Quality Risk Management in GDP

Quality Risk Management (QRM) is a fundamental requirement in the Good Distribution Practice (GDP) environment. It is applicable to a variety of activities and processes, such as temperature mapping studies, supplier qualification, deviations, and change control. In this context, a new post, entitled "A Practical example of applying Quality Risk Management in GDP - Transportation Risks", has been published in the MHRA Inspectorate blog.

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The Responsible Person: What are the Key Elements which should be covered a Job Description?

The EU-GDP Guidelines require that wholesale distributors have to appoint a responsible person (RP) for GDP. A written job description of the responsible person should define their authority to take decisions with regard to their responsibilities. But what are the elements which should be covered in such a job description?

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Audit Trail Review for Devices with "Standard Audit Trail" Functions

The topics data integrity/audit trail generate a multitude of questions. Current questions are addressed in a loose sequence of News. Question 8: What is the procedure for devices with standard audit trail functions if only a fraction of the data is relevant for the audit trail review?

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FDA Issues Draft Guidance for Cannabis

The FDA issued a new guideline entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research”. The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

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EMA Clarifies Investigators Responsibilities Regarding the eCRF

The EMA has updated the Q&As on their Good Clinical Practice (GCP) page. In particular, a new Q&A Nr. 13 clarifies the responsibilities of sponsors and investigators regarding data entered into the eCRF and PI oversight. 

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New Version of the Q&As Applying to Clinical Trials

The European Commission (EC) published an updated Version 2.4 of the Questions & Answers relating to the Clinical Trials Regulation.

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Brexit: Sponsors Need to Establish an EU-QP

Sponsors of EU clinical trials, where the QP is currently located in the UK, need to establish an EU-QP by the end of the transition period. In addition the sponsor of a clinical trial or a legal representative must be established in the EU. Read more here.

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Brexit is approaching: Regulations for Pharmaceuticals defined

The European Commission has published a communication to prepare for the end of the transition period. There are also indications for the pharmaceutical sector.

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FDA - Notification of Deviations in Cell and Tissue Products

A while ago, the FDA published an update on Biological Product Deviation with regard to products based on human tissues or cells.

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Mexican API Manufacturer receives Warning Letter

The US Food & Drug Administration (FDA) explicitly explains the deficiencies in the area of quality control in its Warning Letter for the company "Signa SA de CV".

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New Edition of the VDI Standard on Hygiene Training for HVAC Systems

The VDI (Verein Deutscher Ingenieure, Association of German Engineers) has re-issued Part 2 of VDI Standard 6022 on the requirements for hygiene training of persons entrusted with HVAC systems. The latest valid version of this document dates from 1999.

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FDA publishes Guidance for Setting Endotoxin Limits During Development of Investigational Oncology Drugs and Biological Products

At the end of July, the FDA (CDER) published a draft guidance document for setting endotoxin limits during the development of drugs for oncology and biological products.

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New FDA Guidance on Cellular and Tissue Products (HCT/Ps) published

In July 2020, the FDA updated and expanded its series of guidelines on the topic of cell and tissue products with a revised version of the Guideline Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

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FDA publishes Information and Reviews of Biological Research Projects

In addition to the publication of a large number of guidelines and supporting documents in the field of cell and tissue products, the FDA also provides insights into the biological research projects of its scientists on its website.

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Non Compliance Report for Deficiencies in Contamination Control

In the course of an inspection by the responsible supervisory authorities, considerable deficiencies in GMP compliance were discovered at a Polish manufacturer of non-sterile dosage forms.

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ISO TR 20416 on Post-Market Surveillance published

The new ISO Technical Report on Post-Market Surveillance for medical devices has been published this month. It shall help to implement a Post-Market Surveillance Process according to (EU) MDR 2017 / 745.

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ASMF: Two API Manufacturing Sites Listed - Only One to Be Registered?

This is now also possible for ASMFs and the procedure is clearly described in the updated Q&A document of the CMDh.

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Inspectorates start again with domestic Inspections

Inspectorates are restarting domestic on-site inspections. Announcements were made by FDA and MHRA.

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FDA Warning Letter to Homeopathic Product Manufacturers due to Quality Issues

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Washington Homeopathic Products, Inc. due to specific violations of CGMP regulations. These violations include failure to establish an adequate quality control unit, failure to conduct at least one test to verify the identity of each component of a drug product, and failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.

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ISO TR 24971 Guidance on Risk Management published

The new ISO TR ISO/TR 24971:2020 Guidance on Risk Management for medical devices has been published last month. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.

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FDA Warning Letter: Lack of Lab Data Integrity

Once again, the lack of laboratory data integrity, beside other observations, caused the issuance of a US-American FDA Warning Letter and resulted in deficiencies mainly focused on the solvent recovery processes.

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Pharmacovigilance Audits and Inspections during COVID-19

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes new Q&As relating to pharmacovigilance activities like CAPAs, Audits and Remote-Inspections.

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CHMP's Assessment Report on Nitrosamines published

The recently published final assessment report of the CHMP describes in great detail the state of knowledge on nitrosamines in human medicinal products. All you need to know about risk assessment, calculation of limit values and analysis of nitrosamine contamination can be found in this document.

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