Guidance

Question 1

What is the Basic structure of Eudralex volume 4

Answer 1

Introduction
Part I - Basic Requirements for Medicinal Products
Part II - Basic Requirements for Active Substances used as Starting Materials
Part III - GMP related documents
Site Master File
Q9 Quality Risk Management
Q10 Note for Guidance on Pharmaceutical Quality System
MRA Batch Certificate
Template for the ‘written confirmation’ for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC
Guideline on setting health-based exposure limits (HBEL) for use in risk identification in the manufacture of different medicinal products in shared facilities
Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holder

Annexes
Glossary
Part IV - GMP requirements for Advanced Therapy Medicinal Products
Other documents related to GMP
Compilation of Union Procedures on Inspections and Exchange of Information
A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use”
Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use
Commission Implementing Regulation (EU) 2021/1248of 29 July 2021 as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6
Commission Implementing Regulation (EU) 2021/1280of 2 August 2021 as regards measures on good distribution practice for active substances used as starting materials in veterinary medicinal products in accordance with Regulation (EU) 2019/6

Question 2

What documents are found in Part 3 of euGMP

Answer 2

Part III - GMP related documents
Site Master File
Q9 Quality Risk Management
Q10 Note for Guidance on Pharmaceutical Quality System
MRA Batch Certificate
Template for the ‘written confirmation’ for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC
Guideline on setting health-based exposure limits (HBEL) for use in risk identification in the manufacture of different medicinal products in shared facilities
Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use.
Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holder