GMP NEWS 2020

WHO Pharmaceutical Water Guideline: Revision goes into next Round

The WHO published the revised draft of its guideline "Good Manufacturing Practices: water for pharmaceutical use" already end of July. The first revised draft of the guideline was published in May 2020. The new, second version contains further changes.

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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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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FDA Issues Draft Guidance for Cannabis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 The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities than other drug developers.

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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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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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