Homework 5 – Process Controls and Documentation Warning Letter to Sunrise Pharma
ID: 54529 • 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
The violations are summarized as follows:
a. Laboratory control mechanisms were not established. The quality control review was not documented and approved at the time of the performance. Also, no type of change or training were provided to the employees to ensure prevention of future failures.
b. Adequate written procedures for production and process control were not present with the firm.
c. For the preparation of the dosage form the firm had no master production and control records to justify variation in the amount of components necessary.
d. No reliable or specific test methods were established by the firm to assess the stability characteristics of the drug products as well as determining appropriate storage conditions and expiration dates.
e. Appropriate controls over computer or related systems were not exercised by the firm and hence it could not be assured if the control records or other records were instituted only by authorized personnel or not.
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