GMP News

Tasks of Quality Control Unit during Validations - FDA Perspective

In addition to guidelines, interpretations of the FDA's CGMP rules can often be found in Warning Letters. A current Warning Letter describes the FDA's expectations of the Quality Control Unit for validations, among other things.

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Fundamental GMP Deficiencies at Disinfectant Manufacturer

Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.

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EDQM: New CEP 2.0

The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM. The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information.

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New JP Ultraviolet-Visible and Infrared Reference Spectra Published

In March 2023, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published the "JP Drafts (March 2023) No.2 ". In this context, five new Ultraviolet-visible and Infrared reference spectra were published.

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Four JP Drafts Related to Balances Published for Public Comments

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Balances. Comments can be submitted until 31 March 2023.

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Final GCP Guideline on Computerized Systems and Data Integrity

The final EMA Guideline on computerised systems and data integrity in clinical trials has now been published. Amongst others, the new document requires procedures to be in place for risk-based trial specific Audit Trail Reviews. In addition, a new expression is defined: ALCOA++.

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St. John´s Wort: Updated EU Herbal Monograph

The EMA published the final updated EU herbal monograph on Hypericum perforatum L. including associated supporting documents and an overview of the comments received.

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USP: New General Chapter Supplier Qualification <1083>

On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.

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Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

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Declaration of Herbal Substances & Herbal Preparations in HMPs

The HMPC issued a concept paper on the revision of the Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products (HMPs).

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FDA´s Guidance on Quality Considerations for Clinical Research with Cannabis

The FDA published the final guidance on Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.

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Recommendations on Decentralized Elements in Clinical Trials

The EU Commission has supplemented the area of clinical trials with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers.

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CTIS: EMA´s Risk Mitigation Plan

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

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FDA Guidance about Considerations for the Design and Conduct of Externally Controlled Studies for Drugs and Biologics

In February, the FDA published a guidance document entitled "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products". This provides recommendations for the sponsors and monitors of clinical trials.

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Consultation on Multi-Stakeholder Platform for improving EU Clinical Trials

The EMA published a Concept Paper and a Press Release on a multi-stakeholder platform to support discussions in the clinical research landscape. The deadline for comments is 3 March 2023.

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CTIS & CTR: Sponsor Questions & Answers

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.

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CTR & CTIS: Quick Guide for Sponsors

A quick guide on the main rules and procedures of the Clinical Trials Regulation (CTR) has been released for sponsors who wish to conduct clinical trials in the European Union (EU) / European Economic Area (EEA) or have ongoing clinical trials in this region.

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CTIS: Questions and Answers on Data Protection

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection. The Q&A document has been created to provide guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS.

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EU Survey on the Implementation of the Clinical Trial Regulation

On 31 January 2023 the Clinical Trials Information System has become mandatory for EU clinical trial applications. However, there are still some issues regarding the functionality of the CTIS. Now, the European Commission, together with the EMA and the HMA, published the results of a consultation on the implementation of the CTR.

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Clinical Trials Regulation - Version 6.3 of the Q&As

The European Commission published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation. The revised version includes a new Annex with information on where sponsors can find national requirements.

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Brexit: Agreement on Northern Ireland Protocol also with Consequences for Medicines

The EU Commission and the UK government have reached an agreement on special arrangements for Northern Ireland (the so-called "Windsor Framework"). Part of it is also a possible solution for medicines.

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EDQM: Supplement 11.2 of the European Pharmacopoeia available

Supplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs.

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FDA Warning Letter to Turkish OTC Manufacturer

The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.

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Consultants: A Universal Remedy for GMP Deficiencies?

The question in the title "Are consultants a universal remedy?" is of course a bit provocative. Yet the sole involvement of a consultant following a 483 deficiency report from the FDA is often insufficient. Why?

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Review of GAMP®5 Second Edition

At the end of July 2022 ISPE published an updated version of the widely accepted GAMP®5 guidance on 'A Risk-Based Approach to Compliant GxP Computerised Systems'. Read a first short review about the content of the revised version here.

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