News

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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Storage and Transportation of IMPs

The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.

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GDP in the US: FDA Guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act

In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."

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GDP Audit Check List for Road Transport Operations

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

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Recent Postings in the GDP Discussion Forum

The European GDP Association, representing more than 4,300 professionals from across the globe, offers a Discussion Forum free of charge for its members. It gives you the opportunity to address your GDP-related questions to a large audience. Several interesting topics have been discussed over the last few weeks. To get an idea, take a look here.

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GDP in the US: FDA Draft Guidance on Wholesaling under Section 503B of the FD&C Act

The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act". Comments can be submitted until 28 August 2023.

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Turkish Authority publishes new Guideline on GDP Inspections

The Turkish Medicines and Medical Devices Agency (TITCK) has published a new revision of its guidelines related to inspections regarding the storage and distribution of medicinal products for human use.

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

The United States Pharmacopeia (USP) intends to revise several chapters of the <1079> series in response to the omission of General Chapter <1118> Monitoring Devices—Time, Temperature, and Humidity.

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Abbreviations in the GDP Environment

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 3

More than 60 participants attended the ECA Webinar "GDP Update 2023" in March. Many interesting aspects were discussed in the Q&A session. In total, about 20 questions were addressed to the speaker, Dr. Christian Grote-Westrick, which he answered in writing afterwards. We have compiled a selection of the questions and answers for you. You can read Part 3 here.

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