Op Ex & Lean Six Sigma / Facilty Design & Management

Answer Key for Validation Quiz

Check your validation IQ here.

In the article "Validating the Validators," we offered four sample questions from a test developed as part of Puerto Rico Polytechnic University’s 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? a. The component has direct contact with the product.

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: a. Process Control

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: a. Written procedures on how cleaning processes will be validated

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


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