Products
G.ONE (GMP-ONE)- One Spot for all GMP Links required in our JEEVAN
GOVERNMENT & REGULATORY BODIES IN THE WORLD
GMP REGULATIONS
USFDA
21 CFR PART 11
21 CFR PART 58
21 CFR PART 110
21 CFR PART 111
21 CFR PART 210
21 CFR PART 211
21 CFR PART...
GMP Regulations
Part 21 of the "Code of Federal Regulations" defines the GMP requirements of the USA for the manufacture of medicinal products and pharmaceutical substances. The current GMP (cGMP) can be found at...
cGMP Guidelines
USFDA:
Guidances (Drugs) - Food and Drug Administration
US FDA Title 21 CFR Parts
PART 11
ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
PART 58
GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES22
PART...
USFDA 483s & Warning Letters
483 Inspection reports - ORA FOIA Reading Room
USFDA Warning Letters - Food and Drug Administration
World Health Organization Public Inspection Reports (WHOPIR)
World Health Organization Public Inspection Reports (WHOPIRs)
Introduction to WHOPIRs
The World Health Organization Public Inspection Reports (WHOPIR) is a summary of the inspection report of
a manufacturing site for Active Pharmaceutical Ingredients (APIs);
a manufacturing site...
APIC Publications - Active Pharmaceutical Ingredients Committee
APIC Publications - Active Pharmaceutical Ingredients Committee
WHO GUIDELINES **NEW**
WHO GMP
Production:
Quality assurance of pharmaceuticals: a compendium of guidelines and related materials [pdf 4.82Mb]
Volume 2, 2nd updated edition
Good Manufacturing Practices for Pharmaceutical Products: Main Principle [pdf 632kb]
Annex 4, WHO Technical Report Series 908, 2003
Good...
WHO Basic Training Modules on Good Manufacturing Practices (GMP)
WHO GMP TRAINING MODULES
Video on "Phases of Pharmaceutical Industry"
An useful video on "Phases of Pharmaceutical Industry"
Video on "Tablet Manufacturing Process"
An useful video on
Tablet Manufacturing Process Part A.
Tablet Manufacturing Process Part B.
