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STAT+: FTC says pharmacy benefit managers are stonewalling requests for information

STAT

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022. A much-anticipated inquiry by U.S.

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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision?

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How should cleaning validation sampling locations be chosen?

European Pharmaceutical Review

A recent paper outlines a process that can be used to select and document worst-case sampling locations to validate cleaning processes. To overcome these concerns, Pluta presents the process and documentation activities undertaken by one company.

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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

But the new Joint Guidance on Virtual and Hybrid International Medical Congresses, from the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) is here to plug that gap.

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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands.

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How to develop GMP compliant software for quality management

GMPSOP

Governments highly regulate pharmaceutical industries. They must follow stringent procedures to validate and maintain their information management systems for GMP compliance.For example, companies located in the USA must comply with the USFDA 21 CFR part 11 regulations.

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Moving to component management & traceability: progress, barriers, and the way forward

pharmaphorum

Component management is fairly new to the regulatory market, with pharmaceutical firms moving from traditional document management systems to more dynamic component content management systems. Most of the information is submitted in the form of unstructured PDF documents, with data embedded into them.