Assignment:
Review the following and then answer the following questions.
- Investigating Out-of Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry
- WARNING LETTER - Strides Pharma Science Limited, MARCS-CMS 576722 - JULY 01, 2019
Questions:
Q1. Explain why the "Quality System" was determined to be inadequate by the FDA. Provide evidence from the Warning Letter to support your response. Identify 3 sections of 21CFR211 (Title 21 of the Code of Federal Regulation, Part 211) that you feel were violated, and explain why. Need Assignment Help?
Q2. After reviewing the 2022 FDA Guidance on handling out of specification test results (only need to read sections I - IV.B.1), what should Strides Pharmaceuticals have done to investigate their failing results? Provide a brief explanation of the steps they should have taken.
Q3. Practice looking up warning letters on the FDA dot gov website.
a. Find the FDA searchable Warning Letter database page.
b. Provide the following information for the most recent Warning letter issued by the Center of Drug Evaluation and Research (CDER).
i. Link to warning letter:
ii. Company name:
iii. List the violation(s) cited and the referenced regulations (if there are more than two violations sited, just provide information on two):
(Note: This will look something like this:
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
-or, for another example:
Your product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).)