ISPE’s Drug Shortage Initiative facilitates communication between the pharmaceutical industry and global
health authorities to understand and address this complex problem.
Patient Initiative: Survey on Patient Experience with
Clinical Trial Materials
A global survey on patient experiences with clinical trial materials, including the suitability of packaging,
labels, technologies, transportation, and storage.
ISPE is leading the charge to bring industry and regulators together for open dialog and exchange.
Communities of Practice Discussions
In-situ testing of final sterilizing filter for parenteral products
Sterile Products Processing, 23 July,
Reference from Eudralex - Volume 4 Annex 1 section 113 (European GMP guidelines).
113. The integr ...
Oral Solid Dosage , 22 July,
Changes in component of formulation of SOD product, by adding a desintegrant, like starch until 3% o ...
MES & RBE in Regulatory Inspections
GAMP, 21 July,
What is your RBE approach and how had it held up in regulatory inspections?
Based on feedback fro ...
SOP for Cleaning
Commissioning and Qualification, 20 July,
I'm currently looking at Cleaning and Cleaning Verification/Validation of equipment used for ...