5 Quality Cmc Considerations

5 – Quality (CMC) considerations

1 5 – Quality (CMC) considerations Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD,

  Quality, Considerations, 5 quality

Establishing and Applying Critical Quality Attributes ...

3 “A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.”

  Critical, Quality, Applying, Establishing, Establishing and applying critical quality

Q12 Step 2b Technical and regulatory considerations for ...

Page 2/36 12 Document History Code History Date Q12 Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation (document dated 31 October 2017).

  Considerations

gfi cmc nasal spray - gmpeye.co.kr

Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products – Chemistry, Manufacturing, and Controls Documentation