Quality Systems

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

Articles

FDA is reviving efforts to establish a Quality Management Maturity program.

FDA Revives Initiative to Identify and Reward Quality Drug Operations 

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

The Role of Technology in CAPAs

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL

Mark White, PhD, is associate director, Biopharma Product Marketing, at Bio-Rad Laboratories.

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Standardization is needed in CAR-T cell therapy development due to its inherent complexity.

Using ddPCR to Asses CAR-T Cell Quality

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.

The author introduces a practical approach to determining the best estimate of probability for passing multiple stage dissolution tests.

Determining the Best Estimate of Probability of Passing Multiple Stage Tests: Part 2—Dissolution

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Technology and CAPA

Sue Marchant is senior vice president of Product at 

Data may be used to improve (or remove) a corrective action/preventive action.

Put a Cap on CAPAs

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

FDA Maps Strategies to Advance Pharmaceutical Quality

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Steven J. Lynn is executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Verifying Compendial Methods

Adam Lambert, PhD, is the VP, product and process development, for Pharmatech Associates, a USP company.

Any improper validation of methods is likely to result in regulatory agency deficiencies that range in degree of severity.

Quality Assurance/Quality Control