European Pharmaceutical Review

SEPTEMBER 25, 2023

Identity testing of raw materials under GMP Good manufacturing practices (GMP) require that materials received for manufacture be tested to confirm identity (eg, 21 CFR 211.84, EU GMP Annex 8). Failure to do so has resulted in several warning letters to manufactures. Process analytics for purification of monoclonal antibodies.

Compounding 95

Compounding Pharmaceutical Companies Pharmaceutical Companies FDA 95

ISPE

NOVEMBER 10, 2022

Later in my career, I started to realize and apply myself to the many gaps that exist between the initial R&D of treatments and how to scale them in manufacturing to bring these products to patients. We need process automation and digitization equipment and tools at a cost and scale that is feasible for early stage therapeutic companies.

Documentation 98

Documentation Compounding Hospitals Immunization 98

ISPE

JULY 7, 2023

USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics Trudy Patterson Fri, 07/07/2023 - 08:45 Features July / August 2023 USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics John F. 1 Some advantages are apparent based on the nature of a continuous processing, including higher efficiency at lower cost.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 15, 2023

In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). 7 An integrative (vs. 7 An integrative (vs.

Packaging 52

Packaging Labelling Health Compliance Process Improvement 52