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How ready are you? Preparing for the impact of EU GMP Annex 1 on primary packaging

European Pharmaceutical Review

While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023. Register your details to read more The post How ready are you?

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FDA’s OPDP Issues Third Letter of 2023

Eye on FDA

The communications vehicle in question was a social media sponsored posting. OPDP took issue with three specific aspects of the promotional communication. First, while presenting the indication in the posting, there was no risk information included in the communication. Pharma communicators take note.

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How Pharmacies Can Prep Now for the 2023 DSCSA Requirements

National Association of Boards of Pharmacy

Well, believe it or not, we are just a little more than a year away from that November 2023 deadline. One requirement that is included in Title II of the Act calls for product tracing at the package level, which had not been explored widely by the industry until recently. How can you prepare for November 27, 2023?

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Chandigarh Calling!

Express Pharma

The latest in this series, Chandigarh Pharma Summit 2023 was successfully hosted by Express Pharma recently. In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.

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FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

Assessing drug manufacturing facilities using alternative tools The FDA stated in the guidance that all manufacturing, packaging, and control sites for drug substance and drug product facilities are expected to be ready for inspection at the time of application submission.

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Putting the "Community" in Community Pharmacy

Flip the Pharmacy

I was able to communicate with not just the champions, but also with coaches, owners, and even techs involved in the process. When talking about growth, many members of Team Arkansas mention the idea of “cohesion” and “communication.” A majority of champions and coaches have praised FTP's follow-up and communication with them.

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NABP Pilot Brings Trading Partners, Regulators Together for Public Health Protection

National Association of Boards of Pharmacy

By November 27, 2023, the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) will be fully implemented. We’ve been working with the boards of pharmacy, other regulators, and trading partners to prepare for the requirements included in Title II of the Act, which calls for product tracing at the package level.