Homework 6 – Process Controls and Documentation / Control of microbiological con

Question

Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture. Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture. Homework 6 – Process Controls and Documentation / Control of microbiological contamination Warning Letter to Apotex, Inc. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm344476.htm Whole class: Summarize all cGMP violations by Apotex emphasizing specific violations. What test is done to demonstrate unidirectional air flow that is required of an aseptic manufacturing facility? Be sure to describe violations that are related to product defects and deviation/ discrepancy investigations that were covered in the last lecture.

Explanation / Answer

The sum of violations are as follows- 1- The laboratory records including complete data from all the test were not ensured with established specification and standard.2- Firm failed to establish and follow written procedure, designed to prevent objectionable microorganism in drug product. 3- No proper written procedure for quality control unit and even failed to review and approve all drug products. 4- Inefficient to control over computer or related system to assure that only personnel institute changes in master production and controls records.

Related Questions

Navigate

• Browse (All)
• Browse H
• Subjects

---

---

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.