Quality Systems

Articles

Industry experts discuss best practices for certificates of analysis.

The Role of CoAs in Supplier Oversight

Marina Necdina has more than 10 years of exerience as a bench scientist specializing in the areas of biochemistry, cell biology, and drug manufacturing.

New medications show exciting outcomes for weight loss.

Are Obesity Drugs the Next Blockbusters? 

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

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Principles of Equipment Qualification

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

USP Revises Drug Compounding Chapters

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program. 

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

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

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA Embroiled in Reproductive Rights Debate

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Pressure Mounts for FDA to Reform Accelerated Approval Program

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

Regulatory Oversight and Compliance