Quality Systems

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Articles

Hedley Rees, managing director at PharmaFlow Ltd and a member of the CPhI expert panel, shares his views on pharmaceutical supply chain issues.

Pharma’s Supply Chain Crisis and the Myth of Globalization

CPhI expert, Girish Malhotra, warns that without urgent regulatory reform, the industry would remain reluctant to make process changes that will improve manufacturing efficiency due to the financial and time constraints of re-approval.

Improving Manufacturing Efficiency Requires Regulatory Reform

Piramal says pharmaceutical companies should strive to improve their processes, not just for original patented products but efforts should go beyond DMF and ANDA submissions.

Pharma Urged to Embrace Green Chemistry

EDQM clarifies elemental impurities guidelines for veterinary and other products.

Impurities Guidelines Clarified for Veterinary Products

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Quality by Design in Solid-Dosage Manufacturing

Process analytical technology is crucial for understanding a pharmaceutical or biopharmaceutical process. Thorough process knowledge is needed to develop process control strategies and select process equipment configuration for continuous manufacturing.

PAT Paves the Way for Continuous Manufacturing

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Taking the Pulse of Manufacturing Trends and Equipment Use

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

European Pharmacopoeia Commission Updates Ph.Eur.

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

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

Quality Systems Key to Lifecycle Drug Management

PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.