Quality Systems

Kevin M. Kane, PhD, is CMC strategy director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Eugene J. McNally, PhD, is vice-president, early engagement and regulatory strategy, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Jeff L. Garwin, PhD, MD, is associate clinical science director, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Debra A. Schaumberg is vice-president and global head, Strategic Development Consulting, at PPD, part of Thermo Fisher Scientific.

Articles

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

Exploring an Intelligent Drug Development Paradigm

Environmental monitoring data can help keep sterile environments sterile.

Microbe Monitoring

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Drug Product Impurities Testing

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

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

Gaining a Deeper Understanding of Aseptic Needs

Ghada Haddad, PhD, is executive director, Global Quality Transformation Global Quality Shared Services & Regulatory Intelligence Merck & Co.

Darshana Patel is an associate director in Global Quality at Merck & Co., Inc.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

Navigating the Formality Spectrum in ICH Q9(R1)

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Data from environmental monitoring can assist in keeping sterile environments sterile.

Monitoring for Microbes

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Automation can be balanced with operator oversight.

Good Practices for Data Integrity

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

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

The Inspection Result: Warning Letters and Form 483s

Feliza Mirasol is the science editor for 

Under the €35 million (US$37 million) investment, MilliporeSigma will expand its sites in Glasgow and Stirling, Scotland, to increase biosafety testing for drug development and commercialization.

Quality Assurance/Quality Control