Tag Archives: according to the FDA’s 2022 guidance on out-of-specification (OOS) test results?

Strides Pharma Warning

Homework Assignment 2

Pathway for Patient Health

Global Regulatory and Legal Requirements of Quality

Complete this assignment by typing your answers into this Word document

 

First Name:

Last Name:

 

Email address:

 

· Save this file as: First Name Last Name GRLR Project 2 (e.g. Marla Phillips GRLR Project 2.doc)

· Submit this assignment in Canvas

· Assignment due dates are as listed in the syllabus.

· Generative AI use is not allowed on this assignment.

 

This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)

 

Review the Warning Letter issued to Strides Pharmaceutical by the FDA on July 1, 2019.

 

Resources you will need for this Assignment:

· As the warning letter under review in this assignment may not be available on the active www.FDA.gov website, a copy has been provided in your class materials.

· The 2022 FDA Out-of-Specification Guidance. https://www.fda.gov/media/158416/download

Strides Pharma Warning

Questions:

1. 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.

( Hint: See the assignment rubric below to ensure that you are providing a complete answer.)

2. 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.

( Hint: See the assignment rubric below to ensure that you are providing a complete answer.)

3. Practice looking up warning letters on the FDA.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).)

 

 

 

 

Grading Comments for Question 1	Score for Question 1 (Possible 4)

 

Grading Comments for Question 2	Score for Question 2 (Possible 4)

 

Grading Comments for Question 3	Score for Question 2 (Possible 2)

 

 

 

Rubric:

	Does not meet requirements	Some requirements met	Good	Excellent
Questions 1	No engagement/effort with this question. (0)   Use of AI (0)	The student identified some minimal examples of quality system violations, but did not provide CFR references or explanation. (1)	The student identified examples of quality system violations, provided CFR references, but did not explain how the CFR sections were violated. (2-3)	The student identified examples of quality system violations, provided CFR references, and explained how the CFR sections were violated. (4)
Question 2	No engagement/effort with this question. (0)   Use of AI (0)	The student attempted to identify what Stride should have done to investigate the failing results, but the explanation was inadequate, and the student did not describe the steps. (1)	The student identified what Stride should have done to investigate the failing results, but did not describe the steps. (2-3)	The student identified what Stride should have done to investigate the failing results, and described the steps (4)
Question 3	No engagement/effort with this question. (0)   Use of AI (0)	The student provides a reference to a warning letter from an FDA Center other than CDER (0.5)	The student identifies and references a CDER issued warning letter but does not accurately identify the violations and CFR references. (1-1.5)	The student identifies and references a CDER issued warning letter and correctly provides the requested information. (2)

 

Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org