The Validation Clean room

Running head: Validation Cleanroom
Validation Cleanroom
Name of the Student
Name of the University
Author Note

Validation Cleanroom 1
Table of Contents
Introduction:...............................................................................................................................2
Project Team:.............................................................................................................................2
SCOPE of the project:................................................................................................................2
URS requirements......................................................................................................................3
Standards/ regulations:...............................................................................................................3
Risk assessment:.........................................................................................................................4
Documentation requirement:......................................................................................................5
Management of change:.............................................................................................................5
OQ protocol:...............................................................................................................................5
Possible acceptance criteria:......................................................................................................5
Process to verify validation status:.............................................................................................5
Conclusion:................................................................................................................................6
References:.................................................................................................................................7

Validation Cleanroom 2
Introduction:
The purpose of this paper is to make a report on validation cleanroom project. The
validation cleanroom is very much important part to achieve the compliance of cleanroom.
As well as in addition to the validation, that is prior to the operation, more work on validation
is very much needed at the time of operation for ensuring that a cleanroom is continuing to
meet the class parameters of ISO. The cleanrooms have been validated by the validation
agencies who are third parties. This can entail inspection thoroughly as well as various tests.
The cleanroom has been certified to a special class that indicate the control level of it, to a
class of ISO14544-1.
Project Team:
The validation is having several phases that is starting with the qualification of design
and ending with the final certification. Some of the tests can be performed in the phases
including velocity testing and airflow volume. The project team will work with for accessing
the needs of the clients. It is used to build the custom testing schedule (Díaz et al., 2014). The
project team must consider the ISO standard or GMP requirements. They validate the needs
of the frequency. It includes annual as well as interim testing. They consider the URS, risk
assessment and monitoring plan.
SCOPE of the project:
If a tester performs the cleanroom testing continuously then it can help to identify any
harmful resources. It assures the regulatory client to control the environment. It is used to
meet the ISO parameters. If the cleanroom testing does not have any current validation
process then it limits are set out in ISO 14644-1: 2015 (Kaur, Singh & Seth, 2013). It ensures
sufficient protection to the critical resources. The Scope can define by the risk assessment of