Quality Systems

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

Articles

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, provides simple answers to frequently asked questions regarding batch records.

Frequently Asked Questions about Batch Records

Element has opened a new 7500-ft3 facility that will be used to evaluate aerosolized product efficacy for reducing airborne organisms and viral particles.

Element’s New Air Treatment Testing Facility Supports Indoor Space Public Health Air Quality

Jennifer Markarian is a contributing editor for 

Data analytics, modular equipment, digital tools, and risk-based validation improve speed, flexibility, and quality. 

Streamlining Equipment Quality and Flexibility

Industry experts discuss best practices for certificates of analysis.

The Role of CoAs in Supplier Oversight

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

Single-use systems can benefit from standardized risk assessment and analysis protocols, which can facilitate the way in which processing equipment components are compared.

Considerations for E&L Analysis in Single-Use Systems

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

Aloka Srinivasan, PhD, is Principal and Managing Partner, Raaha LLC.

Chuck Lambert, PhD, DABT, ERT is principal toxicologist at Intrinsik Ltd.

The authors discuss the differences in mechanism of activation of N-nitrosamides versus N-nitrosamines and the fact that they should not be treated the same.

Nitrosamides–Should They Be Treated the Same as Nitrosamines?

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

CBER maps modernization plan to handle surge in research and applications. 

FDA Expands Oversight of Cell and Gene Therapies

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.

Quality Assurance/Quality Control