A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel. Q. Creating a ...

The mass production of pharmaceuticals has significantly evolved since the industrial fabrication of synthetic drugs towards the end of the 19 th century 1 with efficient developments in process ...

Cell therapy manufacturing is uniquely vulnerable to contamination, variability, and operational burden because the product - ...

As demands for aseptic manufacturing increase, partnerships with solutions providers will be key to ensuring safe, versatile and optimized drug containment.

In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be ...

The EU GMP Annex 1 revision has indicated that each company has a contamination control strategy. But what does such a strategy look like? What are the core elements? And how can risk assessment be ...

As Advanced Therapeutic Medicinal Products (ATMPs) surge in popularity and the market sees an increase in therapy development and available products, contemporary manufacturing processes must align ...

On Thursday the 23 November 2023, the PDA Ireland Chapter hosted an event on Microbiology – The Key to Compliance with Annex 1 and Risk Based Regulations. This sold-out event was led by industry ...

(MENAFN- Market Press Release) December 6, 2025 6:40 am - Pharmig India 2025 concludes with strong industry participation, reinforcing sterility, contamination control, and GMP excellence in pharma ...