PIC/S Proposes Specific GMP Annex For Advanced Therapies
The proposal will help take account of international developments
Executive Summary
Authorities from the international Pharmaceutical Inspection Co-operation Scheme have suggested splitting the existing Annex 2 of the PIC/S good manufacturing practice guide in a bid to resolve divergences with the EU ATMP manufacturing guide.
You may also be interested in...
Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies
Risk-based approaches are needed to handle the flexibility, subjectivity and unpredictability that comes with quality reviews of these new technologies, Pfizer official says.
EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients
The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.
PIC/S Finds A Way To Solve Divergences With EU ATMP Guide
A targeted stakeholder consultation will soon be launched on proposals to split the Pharmaceutical Inspection Co-operation Scheme's existing guide on biological products into two parts so as to focus separately on manufacturing issues specific to gene therapy and tissue-engineered products.