“Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” published by EMA will come into force on 1 October 2019 (Part II)
- 30 September 2019
- active substance, API, aseptic processing, ATMP, cell based medicinal products, container, decision tree, documentation, dossier, EMA, excipients, filtration, finished dosage form, finished product, GMP, medicinal product, part, Ph. Eur., post-aseptic processing terminal heat treatment, primary, quality, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,
On 8 March 2019, the European Medicines Agency (EMA) published final version of Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. This guideline will come into force on 1 October 2019. Guidance is also provided on the documentation expected for sterile finished products, sterile active