Homework 5 – Process Controls and Documentation Warning Letter to Sunrise Pharma
ID: 670953 • Letter: H
Question
Homework 5 – Process Controls and Documentation Warning Letter to Sunrise Pharmaceutical http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197966.htm Whole class: Summarize cGMP violations 1-4 and 6. Go to the subsections of part 211 mentioned in the violations and relate them to the violations. Homework 5 – Process Controls and Documentation Warning Letter to Sunrise Pharmaceutical http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197966.htm Whole class: Summarize cGMP violations 1-4 and 6. Go to the subsections of part 211 mentioned in the violations and relate them to the violations. Homework 5 – Process Controls and Documentation Warning Letter to Sunrise Pharmaceutical http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm197966.htm Whole class: Summarize cGMP violations 1-4 and 6. Go to the subsections of part 211 mentioned in the violations and relate them to the violations.Explanation / Answer
According to the document the violations are
No review on Quality control and performance.
No documnetation for the procedures acquired for the production and process controls of the drug product.
No proper central control for varying the components when the dosages change
No proper testing methods carried out for determining the stabilty of drugs
No proper control over the records
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