Regulatory/GMP Compliance

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.

President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

Scientific innovation and regulatory reformations are helping to drive the global biopharma market forward, but a balance between cost and value still needs to be accepted for widespread adoption.

Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.

Rafael Beaus, Global Consultancy Manager, Azbil Telstar, discusses Annex 1 and trends in aseptic production.

Luke Stockhausen, Lead Process Engineer, CRB, talks about technological advances, processing line changes, and new solutions to overcome challenges in aseptic processing.

Richard Denk, Senior Consultant Aseptic Processing and Containment, SKAN AG, discusses the evolution of aseptic processing with a particular focus on isolators.

Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.

FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.

BioPharm International checked in with AAPS, IPEC-Americas, and PDA to get an update on how the organizations are navigating the pandemic and planning for the future.

Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

Industry representatives sound off on FDA’s FARS report, released in January this year.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.