Continuous manufacturing offers great promise in improving productivity, efficiency and the intrinsic quality of both active pharmaceutical ingredients and formulated products.
Continuous manufacturing was defined by ICH Q13, the latest version of which completed consultation in 2021, was adopted by CHMP in December 2022 and officially came into effect in the EU in July 2023. The guidance is applicable to continuous manufacturing for new products and the conversion of batch to continuous manufacture for existing products. Changes to the definitions and processes around batch manufacture that carry through into analysis and release of the pharmaceutical product are described with concepts, scientific approaches, and regulatory considerations specific to continuous manufacture of drug substances and drug products.
This symposium will critically examine some of the challenges and opportunities that arise from adopting continuous manufacturing.
Leading regulators, industrialists and academics will be sharing their experiences in the development, manufacturing and quality assurance of continuous manufacturing of drug substances and drug products.
The meeting is open to the submission of abstracts for oral presentations or posters in line with the above proposed key themes.
Continuous manufacturing was defined by ICH Q13, the latest version of which completed consultation in 2021, was adopted by CHMP in December 2022 and officially came into effect in the EU in July 2023. The guidance is applicable to continuous manufacturing for new products and the conversion of batch to continuous manufacture for existing products. Changes to the definitions and processes around batch manufacture that carry through into analysis and release of the pharmaceutical product are described with concepts, scientific approaches, and regulatory considerations specific to continuous manufacture of drug substances and drug products.
This symposium will critically examine some of the challenges and opportunities that arise from adopting continuous manufacturing.
Leading regulators, industrialists and academics will be sharing their experiences in the development, manufacturing and quality assurance of continuous manufacturing of drug substances and drug products.
The meeting is open to the submission of abstracts for oral presentations or posters in line with the above proposed key themes.
