09.06.2022

GMP Compliance Adviser Update No 3/2022

The following overview lists the topics covered with this Update:

Information

GMP in Practice

Chapter 2 Personnel
2.E Function owners
Chapter 5 Pharmaceutical Water
5.A Water qualities
5.B Pharmaceutical Water Generation
5.D Qualification of water supply systems

GMP Regulations

Chapter C EUDirectives and Guidelines
C.7 Compilation of Union Procedures on Inspections and Exchange of Information
C.10 EU Directives on Medical Devices
C.10.2 Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EUIVDR)
Chapter G GMPofother Regions
G.2 Canadian Regulations
G.2.1 Good manufacturing practices guide fordrug products (GUI-0001)
G.2.2 Annexes to GUI-0001
G.2.2.1 Annex 7 to the Good manufacturing practices guide for drug products – Selected non-prescription drugs (GUI-0066)
G.6 Australian Regulations
G.6.3 Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products
G.6.4 GMP clearance guidance