Newsletter | November 21, 2024

11.21.24 -- Safety Cabinets' Essential Role In EU GMP Annex 1

FEATURED EDITORIAL

Safety Cabinets' Essential Role In EU GMP Annex 1

A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and installation, per Annex 1.

Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards

A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.

Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies

In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.

INDUSTRY INSIGHTS

Manufacturing Challenges With High Concentration Biologics

Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

The Benefits Of Outsourcing Your Biomanufacturing To A Polish CDMO

As you search for a global manufacturing partner, consider the benefits of working with a CDMO based in Poland, including high quality and technical precision at an attractive cost.

NEWS HEADLINES

Sandoz Receives European Commission Approval For Afqlir® (aflibercept), Further Strengthening Leading Biosimilar Portfolio

Celltrion Announces The Acquisition Of iQone Healthcare Switzerland, Further Building Its Expertise And Foothold In Europe

#SaveBigWithBiosimilars Campaign Provides Sustainable Solutions For Employer-Sponsored Health Benefit Plans

Sandoz Opens New Device Development Center In Cambridge, UK

SOLUTIONS

Accelerating Bulk Harvest Release Testing With A PCR-Based Solution