The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. Jean-François Dulière, ISPE Comment Team Lead, breaks down the details on the developments.
Cover: The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. New sections on scope, utilities, environmental monitoring, and process monitoring; a reorganized and restructured content for a more logical flow; and the introduction of QRM principles make the new and improved Annex 1 critically important for the pharmaceutical industry. Jean-François Dulière, ISPE Comment Team Lead, breaks down the details.
Feature: Efficient powder handling and processing is essential for competitive drug manufacture, since most pharmaceuticals, especially oral solid dosage products, are in powder form at some point. While PAT for powder processes has advanced considerably over the last decade, the current analytical solution is suboptimal in some areas, especially related to continuous manufacture. Tim Freeman of Freeman Technology explains.
Special Report: A team of writers from the ISPE Quality Metrics Initiative team report on recent developments, including the proposed ISPE Advancing Pharmaceutical Quality program, an MOU between ISPE and PDA to exchange quality metrics and quality culture information, the development of a CAPA maturity pilot framework and a cross-functional subteam to evaluate and report on the planned FDA quality metrics portal