Useful Links
A curated collection of regulatory, technical and industry resources for the pharmaceutical and engineering sectors.
Industry Resources & References
We've compiled the most useful regulatory, technical and industry links to help you stay informed and compliant.
Regulatory Authorities
US FDA
United States Food & Drug Administration
MHRA
Medicines & Healthcare products Regulatory Agency – UK
WHO – Medicines
World Health Organization pharmaceutical standards
CDSCO India
Central Drugs Standard Control Organisation – India
TGA Australia
Therapeutic Goods Administration – Australia
EMA Europe
European Medicines Agency – Europe
GMP & Quality Standards
WHO GMP Guidelines
WHO Good Manufacturing Practice guidelines
PICS – GMP Guide
Pharmaceutical Inspection Co-operation Scheme
Schedule M – India
GMP requirements for premises, plant & equipment
ICH Guidelines
International Council for Harmonisation – quality guidelines
ISO 14644
Cleanroom classification and monitoring standards
Pharma Industry Resources
ISPE
International Society for Pharmaceutical Engineering
Pharmtech
Pharmaceutical Technology – industry news and resources
CII Pharma
Confederation of Indian Industry – pharmaceutical committee
IPA India
Indian Pharmaceutical Alliance – industry association
FICCI
Federation of Indian Chambers of Commerce – Health division
Engineering & Technical
Government & Industry Schemes
Make in India – Pharma
Government pharmaceutical manufacturing initiative
PLI Scheme – Pharma
Production Linked Incentive scheme for pharmaceuticals
FDA 483 Database
FDA inspection observations and warning letters
WHO Prequalification
WHO prequalification of medicines and diagnostics
USFDA Drug Databases
FDA databases for drugs and regulatory information