Manufacture of the finished dosage form (human) - Scientific guideline

This document provides clarification on the type and level of information that should be included in the common technical document module 3 of the marketing authorisation application dossier with respect to the manufacturing process description. It also addresses aspects related to increased outsourcing and new manufacturing practices such as complex manufacturing chains or issues with prolonged holding times and transportation conditions.

Keywords: Manufacture, drug product

Current effective version

Guideline on manufacture of the finished dosage form - Revision 1

Adopted Reference Number: EMA/CHMP/QWP/245074/2015 Summary:

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline (ref 1) are also taken into account.

Document history - Revision 1

Guideline on manufacture of the finished dosage form - Revision 1

Adopted Reference Number: EMA/CHMP/QWP/245074/2015 Summary:

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect the requirements as laid down in the current legislation Directive 2001/83/EC, and to follow the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the ICH Q8 guideline (ref 1) are also taken into account.

Overview of comments received on 'Draft Guideline on manufacture of the finished dosage form' (EMA/CHMP/QWP/245074) - Revision 1

Reference Number: EMA/CHMP/QWP/104223/2016

Draft guideline on manufacture of the finished dosage form - Revision 1

Draft: consultation closed Consultation dates: 09/07/2015 to 09/01/2016 Reference Number: EMA/CHMP/QWP/245074/2015 Summary:

This guideline replaces the note for guidance on the manufacture of the finished dosage form (CPMP/QWP/486/95). The note for guidance has been updated to reflect changes to the format and content of the Common Technical Document (CTD) Module 3 dossier. It also addresses current manufacturing practices in terms of complex supply chains and worldwide manufacture. In addition, the content and principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8 guideline (ref. 1) is also taken into account.

Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form - Revision 1

Draft: consultation closed Consultation dates: 04/07/2013 to 31/12/2013 Reference Number: EMA/CHMP/QWP/324350/2013 Summary:

This concept paper addresses the need to update and revise the note for guidance on manufacture of the finished dosage form. This guideline was originally adopted in September 1995 and came into operation on 1 April 1996. Since then, the references to directives and the format of the dossier have been changed, and new guidance has been developed. Also the manufacture of the finished dosage form has spread worldwide and terms like holding time and bulk product are now important part of the description of the manufacturing process.

Document history - First version

Note for guidance on manufacture of the finished dosage form - First version

Adopted Reference Number: CPMP/QWP/486/95 Legal effective date: 01/04/1996