Transcription of Q12 Step 5 Technical and regulatory considerations for ...
{{id}} {{{paragraph}}}
Example: quiz answers
Q12 Step 5 Technical and regulatory considerations for ...
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 04 March 2020 EMA/CHMP/ICH/831751/2017 Committee for Medicinal Products for Human Use ICH guideline Q12 on Technical and regulatory considerations for pharmaceutical product lifecycle management - annexes Step 5 Transmission to CHMP 14 December 2017 Adoption by CHMP for release for consultation 14 December 2017 Start of consultation 14 December 2017 End of consultation (deadline for comments) 14 December 2018 Final adoption by CHMP 30 January 2020 Date for coming into
concepts in chapter 3.2.3.1. “EC” refers to the identification of ECs; “reporting” refers to the assessment of appropriate reporting category. Excipient specifications are ECs and managed in line with the Pharmacopoeia. Equipment operating principle is an EC in all cases. Minimal Parameter-Based Approach • API PSD
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: