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Reference Standards - JP Download

Reference Standards - USP Download

Residual Solvents - USP <467> Download

Inspections - Quality Working Party - EMEA Download

Inspections - Good Manufacturing Practice - EMEA Download

Certificates of Medicinal Products - EMEA Download

Inspections - Sampling and Testing - EMEA Download

BSE in Products Regulated by FDA Download

Patents and Exclusivity Download

Pharmaceutical Excipients Download

Combination Product Download

Drugs - USFDA Download

The Orange Book Download

Drug Information Download

CTD for the Registration of Pharmaceuticals for Human use Download

Limits of Genotoxic Impurities Download

ICH Q9 Quality Risk Management Download

Current Good Manufacturing Practices (cGMP) for Drugs - USFDA Download

GMP requirements for API - Denmark Download

Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals - Human Drug CGMP Notes Download

Pharmaceutical Sciences - Health Canada Download

Pharmaceutical cGMP Initiative Questions and Answers - USFDA Download

Notice to Applicants, Volume 2B - Europe Download

USP Verified Drug Substance Verification Program Download

USP Glycerin Monograph Download

Residual Solvents in ANDA Download