article thumbnail

FOPE & PharmaState Academy conducts session 17 on gap analysis and implementation plan for Revised Schedule M

Express Pharma

hour workshop provided participants with direction, supplementary documentation, and hands-on learning, ensuring they were well-equipped to meet compliance requirements. Close to 200 participants attended the online workshop. He provided detailed responses on compliance challenges & documentation requirements.

article thumbnail

USP announces new Advanced Technologies Laboratory to accelerate and scale pharmaceutical manufacturing innovations

Pharmacy Times

The Advanced Technologies Lab will help industry and regulators accelerate the adoption of new technologies that help to mitigate supply chain risks and, where appropriate, establish guidance that supports regulatory predictability, process efficiencies, and faster time to market, all of which can strengthen domestic manufacturing capabilities.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

CDMO Live 2025 to spotlight the future of pharmaceutical outsourcing in Europe

Express Pharma

As the sector continues its rapid expansion, with a 7 per cent annual growth rate, the event will highlight the increasing reliance on contract development and manufacturing organisations (CDMOs) in bringing new therapies to market.

article thumbnail

Sustainable energy strategies for pharmaceutical manufacturers

European Pharmaceutical Review

Independently run workshops can be a powerful way to support the development of a decarbonisation roadmap for any organisation, enabling information to be shared and improving levels of understanding about energy efficiency, generation and procurement. About the author. Andrew Toher is Head of Customer Insights Europe at Enel X.

article thumbnail

Pharmaceutical Continuous Manufacturing: Regulatory landscape in the spotlight at USP workshop

Quality Matters

FDA representatives emphasized the agency’s commitment to working with industry to mitigate potential regulatory hurdles to PCM adoption during USP’s workshop on “ Identifying and Addressing Barriers to Continuous Manufacturing Adoption ” July 18-19 in Rockville, Maryland. It is not intended as a comprehensive summary or report.

article thumbnail

Pharmaceutical Continuous Manufacturing: Right for some products, but not all, and hurdles abound – workshop

Quality Matters

For certain drug substance and drug product manufacturing processes, PCM can bring opportunities to enhance flexibility and efficiency, lower production costs, cut environmental footprints, accelerate scale-up when needed, improve process control, and reduce potential quality issues, workshop participants reported.

article thumbnail

Q&A with Mrunal Jaywant: How the Discovery of Nitrosamines in Medicines Shifted the Pharmaceutical Manufacturing Landscape

Quality Matters

This is exactly why we’re committed to providing education through platforms that are accessible to all, including roadshows, regulator workshops, in-person classroom trainings and laboratory demonstration sessions, international conferences, and consistent updates from USP and other members of the Nitrosamines Exchange.