Links and Files
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/advanced-manufacturing-technologies-designation-program
Advanced_Manufacturing_Technologies_Designation_Program_FDA…
Links and Files
https://database.ich.org/sites/default/files/Q2_Q14%20ICH_Step_2_Presentation_2022_0325.pdf
Abstract
Guideline provides a foundation for consistent development of analytical methods…
Links and Files
https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf
Abstract
Guideline establishes the requirements for validationg analytical methods, ensuring consistency…
Links and Files
https://www.pharmtech.com/view/ask-the-expert-complying-with-21-cfr-211-110
Authors
Susan Haigney (PharmTech)
Felicity Thomas (PharmTech)
Abstract
In this episode of…
Links and Files
APIIC-Market-Research-FINAL-1.pdf
Authors
Andrea Adamo
Nina Weatherly
Abstract
An analysis of the opportunities and obstacles associated with the adoption of advanced…
Links and Files
1._Pharmatech_-_Business_Strategy_Overview.pdf
Authors
Richard Steiner (Pharmatech Associates)
Lawrence De Belder (Pharmatech Associates)
Abstract
PCM Landscape
…
Links and Files
https://www.fda.gov/media/165775/download
Abstract
Guideline gives information and requirements for the production of API in pharmaceutical continuous manufactring processes.…
