In: Science

Submitted By klt4
Words 528
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Question 1 (20%)
In your own words, briefly describe your understanding of application of the lifecycle concept to validation.

Process validation is a vital aspect not just for regulatory purposes, but also for the efficient and reliable long-term application of the process. In order to address the performance of the process adequately, process validation is used to identify the relevant parameters, to design the experimental validation studies accordingly and to define appropriate acceptance criteria through process development.
Applying the lifecycle concept to validation, measures should be taken to routinely maintain and control the validated status of the process during initial development, its long-term application and until the process’s discontinuation. These measures include the monitoring of relevant performance parameters through good documentation.

Question 2 (20%)
What activities generally support the validation of a process / product?

Activities that generally support the validation of a process / product include equipment calibration to ensure that the measured variable is accurately monitored; equipment qualification which includes installation qualification (IQ) an audit of the installation against the equipment specifications and drawings and operational qualification (OQ) which confirms that the equipment performs as intended; process development to provide documented evidence of the suitability of all critical process parameters and operating ranges; process documentation wherein the results of the developmental effort are delineated in sufficient detail; performance qualification
(testing) that deals specifically with the evaluation of the process and change control that mandates the formal evaluation of the consequences of changes to the process. Question 3 (20%)
Describe how to apply…...

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