Quality Systems

Articles

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle. 

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins

The ability of artificial intelligence to process large amounts of diverse data cleanly creates more accurate reports for improved drug safety. 

Harnessing Technology to Ensure Drug Safety

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

This article discusses the evaluation of paired content uniformity and weight variation data sets using F and T tests to ensure that batches meet compendial requirements.

Justification of Using Weight Variation Instead of Content Uniformity for Release of Relevant OSD Forms

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Amanda Guiraldelli Mahr is scientific affairs manager, US Pharmacopeia.

Joachim Ermer is head of Analytical Lifecycle Management Chemistry Frankfurt at Sanofi.

Stephanie Sproule is a member. of the USP M&DQ EC.

Jean-Marc Roussel is a  member of the USP M&DQ EC.

Jaime Marach is member of USP Analytical Procedure Life Cycle Joint Subcommittee.

Horacio Pappa is senior director, US Pharmacopeia.

Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.

Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>

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

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Vaccine Development Builds on COVID-19 Breakthroughs

Cheryl Barton is director of PharmaVision, 

Stepwise paediatric investigation plans aim to boost the development of medicines for children.

EMA Guidance on Paediatric Investigation Plans 

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

Good distribution practices ensure appropriate physical storage, distribution, and supply chain security, says Siegfried Schmitt, vice president, Technical, at Parexel.

Securing the Supply Chain with Good Distribution Practices

Mike Hennessy Jr. is the Chairman and CEO of 

That wave beginning to crash over PhRMA’s gunwales may well emanate from a startup mindset, rather than Big Pharma or government policy pundits.

Subsurface Currents 

CHMP recommended the approval of AbbVie’s RINVOQ (upadacitinib) as a treatment for adults with moderate-to-severe Crohn’s disease.

AbbVie Receives Positive CHMP Opinion for Crohn’s Disease Treatment

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA. 

Regulatory Oversight and Compliance