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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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GDP-compliant Storage of APIs: What needs to be considered?

GDP is not limited to pharmaceuticals. Rather, GDP starts earlier, namely with the transport and storage of the active pharmaceutical ingredients (APIs) used for production. But what general requirements actually apply to the GDP-compliant storage of APIs for medicinal products for human use or veterinary medicinal products?

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Falsification of Ozempic Confirmed

Following the recent concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany)  has determined that suspected batches of Ozempic® pre-filled pens contained insulin glulisine instead of the claimed active substance, semaglutide.

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GDP in the US: FDA publishes YouTube Video on DSCSA Implementation

The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research (CDER) has provided a webinar on the Drug Supply Chain Security Act (DSCSA) implementation.

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Checklist for Implementation of GDP Principles - Part 1: Quality System

According to Chapter 1 of the EU GDP Guidelines, wholesale distributors must maintain a quality system setting out responsibilities, processes and risk management principles in relation to their activities. In this article, you will find a checklist to verify the minimum implementation.

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EMA publishes "Toolkit" for Shortages of Medicinal Products

The European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document to facilitate identification of recommendations on critical shortages of medicinal products.

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Competent Authority of Austria issues new GDP Non-Compliance Report

The Austrian Medicines and Medical Devices Agency has entered a new GDP Non-Compliance Report into the EudraGMDP database. The authority writes that major deficiencies were detected in the quality systems of a wholesale distributor, also related to the lacking awareness of the Responsible Person. As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.

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