Good Distribution Practices News

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.

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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.

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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.

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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.

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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?

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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.

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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.

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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.

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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.

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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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13.10.22

GDP Non-Compliance Report: Procurement from Non-Qualified Suppliers

In August 2022, the National Agency for Medicines and Medical Devices of Romania added a new GDP Non-Compliance Report to the EudraGMDP database. The company in question "failed to comply with GDP legislation regarding activities performed (e.g. procuring from entities which are not authorized for wholesaling activities)".

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13.10.22

Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products

The EMA has published a list of the main therapeutic groups in order to avoid shortages of medicinal products in the case of a public health emergency and thus to ensure the supply of critical medicinal products. Another EMA document defines the methodology for establishing and maintaining this list and further lists of critical medicinal products.

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13.10.22

The GDP Quality System: What to consider?

Deficiencies in the quality system repeatedly lead to so-called GPD Non-Compliance Reports. But what are the requirements for the quality system in the GDP environment, and which processes must be in place within the company?

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15.09.22

GDP in the US: New USP Chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas

A proposal for USP chapter <1079.4> Temperature Mapping for the Qualification of Storage Areas has been published for comments in the Pharmacopeial Forum, PF 48(5). It will apply to every link in the supply chain, such as manufacturers, wholesale distributors and third-party logistics providers. The new chapter should be viewed in the context of the United States Pharmacopeia's (USP) efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices.

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15.09.22

GDP Audit Check List for Air Freight Operations

When conducting GDP audits, it can be helpful to work with question lists. We have compiled typical questions for air freight operations.

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