Fundamental information about Good Manufacturing Practices…
GMP literature about facilities and equipment, pharmaceutical water, …
GMP literature about manufacturing, packaging, …
Significant GMP information about qualification and validation…
GMP literature about risk management, inspections, laboratory controls, pharmaceutical quality systems, …
Crucial GMP guidelines and regulations…
GMP literature about microbiology, biopharmaceuticals, medical devices…
Risk Management
established methods of risk analysisincl. ICH Q9
GMP Pocket Guide Volume 4
This book covers all stages of the drug lifecycle from R&D, to the clinical phases, the launch and pharmacovigilance stages, and the discontinuation step.