as of 2019 - 08 - 15
2019
What’s New in Update No. 6/2019?
GMP Regulations
Chapter C
C.2.1.1 Commission Directive (EU) 2017/1572
C.2.1.2 Commission Delegated Regulation (EU) 2017/1569
C.8.2.1 Safety features for medicinal products for human use Q&A – Version 15
Service
What’s New in Update No. 5/2019?
GMP in Practice
Chapter 24 Storage and Transportation
24.G The role of transport in ensuring the safety and quality of medicines
24.H Regulatory requirements for the transport of pharmaceuticals
24.I Transport conditions
24.J Transport vehicles and shipping containers
24.K Modes of transportation
Service
What’s New in Update No. 4/2019?
GMP in Practice
Chapter 14 Laboratory controls
14.C Qualification of laboratory equipment
14.K Pharmacopoeias
GMP Regulations
Chapter C EU: Guideline on Sterilisation of the Medicinal Products, Active Substance, Excipient and Primary Container
Chapter D USA: CFR and FDA Guidelines
D.1.1–D.1.9
D.1.6 21 CFR 600
D.19 Considerations in Demonstrating Interchangeability with a Reference Product
D.21 Questions and Answers on Biosimilar Development and the BPCI Act
G.2 Canadian Regulations
Service
What’s New in Update No. 3/2019?
GMP in Practice
Chapter 1 Quality Management Systems
1.K.5 Serialisation of Folding Cartons in the Pharmaceutical Industry
Chapter 13: Packaging
13.A.10 Pharmaceutical manufacturers and packaging suppliers: Ways to an improved dialogue
13.A.11 GMP aspects when handling print data
13.A.12 GMP aspects in the design of packaging materials
GMP Regulations
Chapter C EU Directives and Guidelines
C.8.2.1 Safety features for medicinal products for human use Question and answers – Version 14
Chapter E ICH-Guidelines
E.3.D ICH Q3D (R1): Guideline for Elemental Impurities
Service
What’s New in Update No. 2/2019?
GMP Regulations
Chapter C EU Directives and Guidelines
Chapter D USA: CFR and FDA Guidelines
Service
Overview of the restructuring
What’s New in Update No. 1/2019?
GMP in Practice
Chapter 3 Premises
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