In the article "Validating the Validators," we offered four sample questions from a test developed as part of Puerto Rico Polytechnic Universitys new certification program. Here, that article's authors provide the answers so you can see how you scored on the quiz.
|1. Company XXX has purchased three Fette compressing machines, all are exactly alike. What type of qualification studies do you need to perform?||IQ & OQ in all three, PQ in only one.|
|2. Which of the following requirements must exist to classify a component as critical?
b. The component supplies a material or solvent that have direct contact with the product.
c. The component is used in the cleaning or sterilization of a product or equipment.
d. The component produces data used in the release or rejection of a product.
e. The component controls or monitors the process in such a way that can affect the product quality.
|All of the above if any one is true, the system should be classified as critical.|
|3. Which of the following is not a Supplier Audit criterion:
b. Product Identification and Traceability
c. Internal Audits
d. Rating Analysis Recap
|4. Which of the following is not a General Requirement in a cleaning validation program:
b. Written validation protocols in advance
c. FDA approval of new drug application (NDA)
d. Validation report stating whether or not cleaning process is valid