Good Distribution Practices News

21.02.23

GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

21.02.23

USP pre-posts Revision to General Chapter <1079.2> and Stimuli Article on Mean Kinetic Temperature (MKT)

The United States Pharmacopeia (USP) has published a Notice of Intent to Revise General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products. With the revision, the inclusion of temperature excursion limits for climatic zone IVb is being proposed. In a Stimuli Article, the rationale for the revision is outlined. Both documents were now pre-posted, to allow stakeholders additional time for reading and understanding.

26.01.23

Update of the EMA Q&As on GDP Requirements

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.

26.01.23

What are the Requirements for Premises and Storage Facilities?

Wholesale distributors must have suitable and adequate premises and storage facilities. But what are actually the specific requirements according to the EU GDP Guidelines?

26.01.23

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.

26.01.23

GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

The U.S. Food and Drug Administration (FDA) has published a so-called untitled letter to a US company. The FDA states that the firm violated the Drug Supply Chain Security Act (DSCSA). Specifically, the letter concerns a former subsidiary of the company that was a licensed pharmacy and wholesale drug distributor.

26.01.23

The GDP Non-Compliance Reports of 2022 - 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. We have prepared an overview of the GDP Non-Compliance Reports published in 2022 and the respective reasons for issuing these reports.

15.12.22

GDP Non-Compliance Report: Numerous Major GDP Violations at Irish Wholesale Distributor

The Irish Health Products Regulatory Authority has added a new GDP Non-Compliance Report to the EudraGMDP database. During an inspection of a wholesale distributor, a number of major deviations from Good Distribution Practice were found, leading to an immediate suspension of the authorisation.

15.12.22

Change Control for Transport Processes

Any change from design or predefined processes requires risk assessment and potential impact evaluation for both the transport process and, consequently, the product. This article discusses the importance of having a structured, compliant Change Control (CC) process in place for medicinal product manufacturers as well as for their qualified logistics vendors.

15.12.22

Qualification of Suppliers - What needs to be considered?

According to the EU GDP Guidelines, wholesale distributors must obtain their supplies of medicinal products only from persons who themselves hold a wholesale distribution authorisation or a manufacturing authorisation which covers the product in question. Thus, all suppliers must be qualified in an adequate way. But what is the rationale for this point and how to implement the requirements?

15.11.22

FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

15.11.22

GDP for Veterinary Medicinal Products: EMA updates Q&A Document

The European Medicines Agency (EMA) has updated the answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website. The newly inserted section revolves around the requirement relating to the nature of check at the reception of veterinary medicinal products before being transferred to saleable stock.

15.11.22

GDP Non-Compliance Report for Belgian Wholesale Distributor

End of October 2022, the Competent Authority of Belgium (Federal Agency for Medicines and Health Products) added a new GDP Non-Compliance Report to the EudraGMDP database. The authority blames the company in question for a whole series of GDP violations.

15.11.22

Temperature Mapping for the Qualification of Storage Areas

In the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "The Use of Temperature Mapping for the Qualification of Storage Areas for the Proper Temperature Storage of Drug Products" was published.

19.10.22

FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

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GMP for Beginners in Sterile Manufacturing - Live Online Training

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7/8 November 2023

GMP for Beginners in Sterile Manufacturing - Live Online Training incl. Case Studies “Entering the Clean Area” and “Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“

Good Distribution Practices News

GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

USP pre-posts Revision to General Chapter <1079.2> and Stimuli Article on Mean Kinetic Temperature (MKT)

Update of the EMA Q&As on GDP Requirements

What are the Requirements for Premises and Storage Facilities?

FDA Warning Letter due to Inadequate Storage Conditions and Repacking/Relabeling Operations

GDP in the US: FDA warns Company for Violation of Drug Supply Chain Security Act

The GDP Non-Compliance Reports of 2022 - An Overview

GDP Non-Compliance Report: Numerous Major GDP Violations at Irish Wholesale Distributor

Change Control for Transport Processes

Qualification of Suppliers - What needs to be considered?

FDA sends Warning Letters to Amazon and Walmart

GDP for Veterinary Medicinal Products: EMA updates Q&A Document

GDP Non-Compliance Report for Belgian Wholesale Distributor

Temperature Mapping for the Qualification of Storage Areas

FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

Recommended Event

GMP for Beginners in Sterile Manufacturing - Live Online Training incl. Case Studies “Entering the Clean Area” and “Establishing an Environmental Monitoring Program and Handling of Failures in Microbiology“

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