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A) 2001
B) 1987
C) 1999
D) 2003

2. The 2011 PV Guidance focuses on the concept of linking product and process development, qualification, and continuous monitoring of the production process.

A) True
B) False

3. What are the three stages of the PV Lifecycle?

A) Process Design, Process Qualification, Continued Process Verification
B) Process Design, Commissioning, Validation
C) Process Design, Commissioning, Process Qualification
D) Commissioning, Process Qualification, Continued Process Verification

4. At what stage of the PV Lifecycle are critical process parameters identified?

A) Process Design
B) Process Qualification
C) Continued Process Verification

5. Compared to the previous version of the PV Guidance, which stage is the most significant departure from the classical definition of what constitutes process validation?

A) Process Design
B) Process Qualification
C) Continued Process Verification

6. The range of a process parameter or material attribute established during Stage 1 activities, and the acceptable operating or control range during commercial production is known as:

A) Proven Acceptable Range (PAR)
B) Control Strategy
C) Normal Operating Range (NOR)
D) Quality Release Criteria

7. The objective of Continuous Verification is to:

A) Provide the ability to intervene in a process before it drifts out of a state of control
B) Allow process and operational improvements to be made without the need to revalidate
C) Improving process predictability and product performance
D) All of the above

8. Continuous Verification includes all of the following except:

A) Procedure for continuous improvements to the process
B) Identifying the Critical Process Parameters
C) Defining rules for making process adjustments
D) Defining action/control limits for the process

9. Process Validation and Process Qualification are interchangeable terms according to the 2011 guidance?

A) True
B) False

10. Prerequisites to Stage 2 activities must include:

A) Validation facility, utilities, and equipment
B) Three commercial scale manufacturing batches
C) Annual Product Review (APR) process
D) Change Control process