Replaces: CPMP/QWP/054/98 Corr which is an annex to CPMP/QWP/155/96
Categories: Quality | Pharmaceutical development (quality)
TGA annotations:
The document EMA/CHMP/CVMP/QWP/850374/2015 Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container specifies that a terminal steam sterilisation process using the reference parameters specified in Ph. Eur. 5.1.1 (being NLT 121C for NLT 15 minutes) does not require the submission of additional validation data. This aspect of the document is not adopted by the TGA.
The TGA requires the submission of physical and microbiological validation data to support the sterilisation process, regardless of the method or parameters used.
Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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