Quality Systems

Michael Moedler, PhD, is head of Training at Lonza Biologics Operations Visp.

Helene Pora, PhD, is vice-president of Technical Communication and Regulatory Strategy at Pall Corporation.

Articles

Workforce training is crucial for biopharmaceutical manufacturing.

Addressing the Training Gap for Single-Use Technologies

Cheryl Barton is director of PharmaVision, 

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

Regulating Digital Therapeutics

Richard J. Forsyth is principal consultant with Forsyth Pharmaceutical Consulting, 907 Shamrock Ct, Royersford, PA 19468, tel. 484.535.1688, forsythpharmaconsulting@gmail.com.

Dr. Sabine Imamoglu is Product Supply, Pharmaceuticals, Pharmaceutical Affairs, Bayer AG.

Continued process verification for a cleaning validation program begins once the validation study is complete. 

Continued Process Verification for Cleaning Validation– Challenges and Pitfalls

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

Quality Still a Priority

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

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

Good Manufacturing Practice on Demand?

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.

Major Challenges Ahead for FDA and Pharma

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?

Hot Picks for 2022

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

FDA Approves AstraZeneca and Amgen’s Tezpire

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

EMA Recommends Conditional Authorization for Novavax’s COVID-19 Vaccine

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.

Regulatory Oversight and Compliance