3710164 2pg paper Harvard sources 2 attach AI and plag report Witten CA: PAT &

3710164
2pg paper
Harvard
sources 2
attach AI and plag report
Witten CA: PAT & Process Validation Statistics
Corporate headquarters have decided to transfer their new product, Innotab 100mg, developed at their Research and Development (R&D) facility in Rochester, New York, to their commercial manufacturing facility in Sandyford, Dublin, Ireland.
Innotab 100mg, is manufactured by a wet granulation, film coated tableting, technology platform. All equipment is currently on site and is used in the manufacture of existing products at the facility. You are the Validation Engineer assigned to this project. The product will be manufactured for supply to the US market only.
a. A. Write a process validation sampling and testing plan for the manufacturing process. Provide a rationale/justification to support the plan. The plan should include the samples required to be taken at each stage of the manufacturing process, the QC tests to be performed on those samples and the validation acceptance criteria to be applied. (60 Marks)
b. B. Discuss the cleaning validation considerations for the introduction of the manufacture of Innotab 100mg. (40 Marks)
Cleaning validation Source:
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793