Paper details  

CHALLENGE ASSIGNMENT OVERVIEW

This Challenge assignment is designed to bring together the concepts you’ve learned in the prior classes on ICHQ8 (R2). The Challenge requires pre-reading of the following documents:
1. FDA Manual of Policies and Procedures, MAPP 5016.1: “Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review”
https://www.fda.gov/media/79615/download
2. FDA 2011 Guidance for Industry “Process Validation: General Principles and Practices” https://www.fda.gov/media/71021/download
3. FDA Warning Letter to Torrent Pharmaceuticals Limited in October 2019
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/torrent-pharmaceuticals-limited-585255-10082019

INSTRUCTIONS
Read the instructions below closely and complete the challenge assignment as follows.

1. Review the following warning letter issued by FDA to Torrent Pharmaceuticals Limited in October 2019 (pre-read #3).
a. Analyze why the FDA cited ICH Q8 (R2) for the observation. Also Consider:
a. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-huahai-pharmaceutical-566685-11292018
b. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akorn-inc-558914-02042019

DRAFT- JES TO ADD ANOTHER WARNING LETTER

2. Submit your completed Challenge assignment document by the due date. Any references should be appropriately cited within your assignment. Late submissions will not be accepted.

Preferred language style   US English
ICH Q8 (R2) Pharmaceutical Development