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What is IQ OQ protocol?

IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.

How do you qualify for a clean room?

Cleanroom performance qualification involves testing and monitoring of the following: Airborne particulate levels. Surface particulate levels. Viable microbial particulates.It should include the following: Maximum and minimum temperatures. Maximum and minimum humidity. Maintenance schedules. Personnel contamination.

What does PQ mean in quality?

Performance Qualification (PQ) Your process performance qualification protocol will feature verification and documentation that all equipment is working within the accepted range as specified, does it perform as expected under real conditions.

How do you write a performance qualification protocol?

Prepare a Performance Qualification Report: This should include: date study initiated; date completed; observations made; problems encountered; completeness of information collected; summary of deviation report; results of any tests; do results meet acceptance criteria; location of original data; other information

What is the difference between IQ OQ and PQ?

IQ stands for Installation Qualification, OQ for Operational Qualification, and PQ for Performance Qualification. The purpose of process validation is to establish documented evidence that the production equipment is correctly installed, operates according to requirements, and performs safely.

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What comes first OQ or PQ?

The Completion of OQ Leads to Performance Qualification (PQ) During this phase you will generate evidence that your process will consistently produce an acceptable product under normal operating conditions over the long-term.

How do you qualify for area?

The sterile area can be qualified by applying following tests. 1.0 Air supply capacity: 2.0 Air velocity/Uniformity: 3.0 Air change: 4.0 Air Flow Pattern: 5.0 HEPA Filter Integrity Test: 6.0 Pressurisation Test: 7.0 Unidirectional airflow: 8.0 Particle count:

What is PQ validation?

PQ stands for Performance Qualification and is the last phase of the validation process. Here, the equipment will run several times under normal operating conditions and its functions will be challenged.

How do you do area qualification?

The sterile area can be qualified by applying following tests. 1.0 Air supply capacity: 2.0 Air velocity/Uniformity: 3.0 Air change: 4.0 Air Flow Pattern: 5.0 HEPA Filter Integrity Test: 6.0 Pressurisation Test: 7.0 Unidirectional airflow: 8.0 Particle count:

What is an IQ protocol?

The Installation Qualification Protocol verifies the proper installation and configuration of a System. This can include ensuring that necessary files have been loaded, equipment has been installed, the necessary procedures have been approved, or the appropriate personnel have been trained.

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