EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

Regulatory NewsRegulatory News | 14 August 2017 |  By 

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).

The update, drafted in July 2015, comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains.

The guideline "does not introduce new requirements" on authorized drugs, though the guideline notes that the MAA 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."


More specifically, the guideline offers clarification on the type and level of information that should be included in the common technical document (CTD) Module 3 of the 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 says. "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."

Guideline on manufacture of the finished dosage form

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