GMP in Practice

Current topics
0.A Nitrosamines
0.B Cannabis
0.C ATMPs
0.D Remote Audits and Inspections
0.E The 2021 PDA/FDA Joint Regulatory Conference: A First-hand Insight
0.F Importation of Medicinal Products
1 Quality Management Systems
2 Personnel
3 Premises
4 Facilities and Equipment
5 Pharmaceutical Water
6 Qualification
7 Process Validation
8 Cleaning Validation
9 Computerised Systems
10 Hygiene
11 Production
12 Sterile Production
13 Packaging
14 Laboratory Controls
15 Documentation
16 Storage and Transportation
17 Outsourced Activities
18 Audits and Supplier Qualification
19 Quality Risk Management
20 Active Pharmaceutical Ingredients
21 Inspections and Drug Safety

GMP Regulations

A Addresses
B National Bodies and Pharmaceutical Associations
C EU Directives and Guidelines
D USA: CFR and FDA Guidelines
E ICH Guidelines
F PIC/S Guidelines
G GMP of other Regions
- Canadian Regulations
- Japanese Regulations
- Chinese Regulations
- Indian Regulations
- Australian Regulations
- Brazilian Regulations
H WHO Guidelines

Information

- Update history
- GMP Abbreviations
- GMP Glossary
- Contributors