In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…
Supply chain management is an essential chapter in the pharmaceutical manufacturing handbook. Managing regulatory starting materials (RSMs) seeks to maximize commercialization and sustainability while meeting and/or exceeding regulatory requirements. Drugmakers…
There’s a growing consensus in the pharmaceutical industry that drug makers should embrace green chemistry. The last decade of pharma manufacturing has seen green chemistry practices shift from aspirational stewardship…
The idea of gaining – and maintaining – adequate process control during drug synthesis isn’t new. It underscores the entire point of approaches such as Quality by Design (QbD), and…
Demands on a drug’s synthetic processes naturally evolve during its lifecycle. Scouting alternative methods for synthesizing active pharmaceutical ingredients (APIs) early in process development — before they are needed by changing…
Working in the pharmaceutical manufacturing industry may bring many rewards, but it also has an element of risk. We often work alongside hazardous chemicals, in both labs and manufacturing spaces….
Pharmaceutical drug molecules are becoming increasingly complex, posing challenges in formulation development and manufacturing. This is particularly true of small molecule drug APIs and peptides, both of which have a…
New markets for drug manufacturers are emerging worldwide in regions that have typically purchased and imported drugs in finished dosage forms. While this shift has been underway for a few…
A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…
The global market for active pharmaceutical ingredients (APIs) is expected to grow at a 3–6% Compound Annual Growth Rate (CAGR) over the next five years, exceeding U.S. $1.5 trillion by…
