Guideline on manufacture of the finished dosage form

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. This guideline does not introduce new requirements on authorised medicinal products for human use. However as stated in article 23 of Directive 2001/83/EC, after a marketing authorisation (MA) has been approved, the authorisation holder should, in respect of the methods of manufacture and control take account of scientific and technical progress and introduce any changes that may be required to enable the medicinal product to be manufactured and controlled by means of generally accepted scientific methods.

Introduction (background) : The objective of the guideline on the manufacture of the finished dosage form is to provide clarification on the type and level of information that should be included in the CTD Module 3 of the marketing authorisation application (MAA) dossier with respect to the manufacturing process description. This description should include information about critical steps and intermediates and provides a link between the pharmaceutical development, the proposed control strategy and process validation. The guideline also addresses aspects related to outsourcing and new manufacturing practices such as complex manufacturing chains or issues with prolonged holding times and transportation conditions. Detailed information about requirements of the sterilisation process is provided in a separate guideline.

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