News

The GDP Non-Compliance Reports of 2023 - An Overview

If the outcome of an inspection is that the wholesale distributor does not comply with Good Distribution Practice (GDP), a statement of non-compliance may be entered into EudraGMDP. As in previous years, we have prepared an overview of the GDP Non-Compliance Reports published in 2023 and the respective reasons for issuing these reports.

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Checklist for Implementation of GDP Principles - Part 3: Premises and Equipment

According to Chapter 3 of the EU GDP Guidelines, wholesale distributors must have suitable and adequate premises, installations and equipment, so as to ensure proper storage and distribution of medicinal products. In this article, you will find a checklist to verify the minimum implementation.

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Ozempic Falsification also in the US

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warned consumers not to use counterfeit Ozempic® found in the US drug supply chain.

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US Track & Trace Guidance on Verification Systems

The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.

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EU and MHRA extend GMP and GDP Certificates

The validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based.

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ICH Q9 Training Package for Revision 1 published

Since 2005, the ICH Q9 Guideline has been the state of the art when it comes to quality risk management. It was initially included in the EU GMP Guidelines as Annex 20 and was then incorporated into Part III. In addition, an ICH Q9 "briefing package" was developed and made available on the ICH website. New training material is now also available for Revision 1 of the ICH Q9 Guideline.

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Checklist for Implementation of GDP Principles - Part 2: Personnel

Chapter 2 of the EU GDP Guidelines defines the qualification requirements, tasks and responsibilities of all staff and the Responsible Person (RP). In this article, you will find a checklist to verify the minimum implementation.

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GDP in the US: Update on DSCSA Implementation

The Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. In this article, you will find a summary of recent developments.

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GDP Non-Compliance Report documents numerous Deviations at German Wholesaler

The Competent Authority of Germany (Regierungspraesidium Freiburg) has entered a new GDP non-compliance report into the EudraGMDP database. The list of deficiencies identified is quite long and the deviations run through almost all chapters of the EU GDP Guidelines.

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GDP Non-Compliance Report due to Lack of Authorized Storage Facilities

The Competent Authority of Czechia (State Institute For Drug Control) has entered a new GDP Non-Compliance Report into the EudraGMDP database. A wholesale distributor seriously violated the GDP requirements by failing authorized storage facilities.

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