Good Manufacturing Practices Data Integrity Questions

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abun22

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I have four SHORT , DIRECT Case studies in Good Manufacturing Practices. one page or 1/2 the page for each case. ( PART B)

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Running head: GOOD MANUFACTURING PRACTICES

Good Manufacturing Practices

Name:
Institution:
Date:

1

GOOD MANUFACTURING PRACTICES

2

GOOD MANUFACTURING PRACTICES
Notes:
1. Answer in good sentences. If I can't understand, I can't grade it.
2. Select and answer thoroughly 4 out of 6 questions (15 pts each). Spaces are left on Page
12 to answer these questions. Please make sure your answers are concise and direct.
(no more than one (1) page for each answer.)
3. No Recourses use the book and the notes
PART B – Select and answer thoroughly 4 out of 6 questions. Please make sure your
answers are concise and direct. I give an example to demonstrate.
Case Study 1: EXAMPLE
The FDA inspector visited a manufacturer making beta-lactam products. They found that Betalactams are repackaged in a facility that is not dedicated to this product. A proper and vigorous
cleaning procedure is used, and cleaning data are documented. Manufacturing personnel moves
freely between beta-lactam and non-beta-lactam manufacturing areas.
1. What quality system is this?
2. What would happen to this company after the inspection?
3. What are the issues?

Answers: EXAMPLE
(1) What quality system is this? Facilities and Equipment System
(2) What Happened:





After discussions with the FDA, the company recalled the product.
The company ceased the manufacturing of beta-lactams.
The firm decontaminated and renovated the facility.
FDA issued a Warning Letter

(3) The issues:





No safe level of beta-lactams contamination. A severe allergenic response can occur when
exposed to shallow levels of beta-lactams.
Cleaning cannot substitute for proper segregation.
Any test intended to detect beta-lactam contamination provides only limited confidence due
to analytical method limitations.
Complete segregation is important.

Cas...


Anonymous
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