Quality Systems

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

Articles

The further we pursue CGT, the more variability we need to account for in order to engineer consistency into these new products.

Designing Potency Assays for Complex Novel Modalities

Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. 

Theresa Mullin, PhD serves as CDER’s Associate Director for Strategic Initiatives and leads CDER’s International Program in FDA.

Harmonization of global regulations fosters innovation and ensures quality medicines.

Convergence in the Global Regulatory Village

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

The Punctuated  Evolution of Computer Software Validation

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

Shiri Hechter is senior lab operations manager for Nelson Laboratories

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Considerations for Method Validation

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

In light of increasingly stringent sustainability requirements, bio/pharma companies need to make sure they formulate effective ESG strategies.

Setting Goals for Sustainability

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

A CCS provides significant benefits to the industry and helps with holistically understanding contamination controls, says Siegfried Schmitt, vice president, Technical at Parexel. 

Creating a Contamination Control Strategy

Amanda Guiraldelli is Scientific Affairs Manager, United States Pharmacopeia, Rockville, MD.

This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017. 

Evolution of Analytical Procedure Validation Concepts: Part II– Incorporation of Science and Risk-based Principles in ICH Q14 and Q2(R2) Guidelines

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

FDA struggles to track shortages caused by a rise in demand.

Rising Demand Drives Drug Shortages

Peter Zipfell is product marketing specialist, CMD Software, Thermo Fisher Scientific.

The most safe and effective therapies demand the highest data quality. 

Driving Data Quality and Ensuring Compliance Using Modern CDS Solutions 

Somnath Mishra, Somnath.mishra@shabas.net, is president at Shabas Solutions LLC.

William Hauck is senior associate at Shabas Solutions LLC.

Zachary Royal, is senior consultant at Shabas Solutions LLC.

Robert Michalik is advisor (Quality and Corporate Compliance) at Shabas Solutions LLC.

QMM is an evolutionary advancement in FDA’s quality management maturity initiative that provides industry with a viable methodology to assess and improve manufacturing quality and supply chain reliability. 

Quality Assurance/Quality Control