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GDP in the US: USP Chapter and Stimuli Article on MKT

In the Pharmacopeial Forum, PF 49(2), a proposal for a revised USP General Chapter <1079.2> "Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products" and a Stimuli Article "The Use of Mean Kinetic Temperature and the Need of Allowable Excursion Limits for Climatic Zone IVb" were published. Comments can be submitted until 31 May 2023.

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Competent Authority of Czechia issues four new GDP Non-Compliance Reports

After the public access to the GDP Non-Compliance Reports in EudraGMDP did not function for several weeks, reports can now be accessed again. In the meantime, four new documents have been added by the competent authority of Czechia. In all cases, the companies did not provide approved storage facilities.

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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 1

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 1 here.

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GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.

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FDA Warning Letter: Lack of Temperature and Humidity Control

The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

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MHRA GMDP Symposia 2023

The Good Manufacturing and Distribution Practice Symposia 2023, organized by the Medicines and Healthcare products Regulatory Agency (MHRA) were held on 21 and 22 February 2023. The first day of the conference focused on regulatory developments in the area of Good Distribution Practice (GDP).

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Two New PIC/S GDP Guidance Documents Published

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.

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USP: New General Chapter Supplier Qualification <1083>

On August 01, 2023, the new USP Chapter "<1083> Supplier Qualification" will officially enter into force. In the USP Forum, the draft chapter could be viewed and commented on until the end of November 2021.

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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).

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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.

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