Good Distribution Practices News

12.12.23

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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07.12.23

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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14.11.23

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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14.11.23

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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14.11.23

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 As a consequence, the Wholesale Distribution Authorisation (WDA) for human and veterinary medicinal products was withdrawn.

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14.11.23

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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19.10.23

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

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

more

19.10.23

GDP Non-Compliance Report for Spanish Wholesale Distributor

The Spanish Agency Of Medicines And Medical Devices has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a series of deviations from Good Distribution Practice were found. This led to a suspension of the company's authorisation for procuring, holding, supplying and storage by contract of human medicinal products.

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19.10.23

GDP Non-Compliance Report for Austrian Wholesale Distributor

On 09 October 2023, the Austrian Medicines and Medical Devices Agency has entered a new GPD Non-Compliance Report into the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

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18.10.23

Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.

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26.09.23

FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.

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20.09.23

New ZLG Document on Transport Verification Published

At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.

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20.09.23

GDP in the US: Additional FDA Guidances on DSCSA

In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.

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20.09.23

GDP in the US: FDA gives One-Year Reprieve on DSCSA enhanced Drug Distribution Security Requirements

The U.S. Food and Drug Administration (FDA) has published a new guidance document entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies". The document focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024.

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20.09.23

US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.

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