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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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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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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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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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GDP Non-Compliance Report: No GDP conform Quality System

The competent authority of Germany (Thuringian State Authority for Consumer Protection) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. The wholesale distribution authorisation (WDA) of the company concerned was suspended. Among other things, the authority criticized the lack of a GDP-compliant quality system.

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GDP Non-Compliance Report: No WDA without Responsible Person

On 12 July 2022, the competent authority of Germany (Regierungspräsidium Karlsruhe) added a new GDP Non-Compliance Report to the EudraGMDP database. The reason given is the fact that there is no responsible person.

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Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Amazon for selling unapproved drugs for mole and skin tag removal that have not been evaluated by the FDA for safety, effectiveness or quality. Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations. Otherwise, legal action may result.

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GDP Audit Check List for Ocean Freight Operations

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

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GDP in the US: The USP <1079> Series of Chapters on Good Storage and Distribution Practices

The United States Pharmacopeia (USP) continues its efforts to build out the <1079> series of chapters on Good Storage and Distribution Practices. But what is the current status?

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FDA issues revised draft Guidances for Track and Trace

The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.

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