GMP Facility Validation -- 2

I need two separate bits of help in this project-

1. I need someone who can explain me below topics concerning FDA ISO Standards

2. Also, prepare the sample documents for the following points.

1. Installation Qualification Protocol Document (IQ):

1.1 HVAC calibration

1.2 HEPA filter integrity test

1.3 Site Acceptance Tests(SATs)

1.4 Installation Qualification tests

1.5 Piping and welding documentation

1.6 Utility verification

1.7 Environmental review report

2. Operational Qualification Protocol Document (OQ):

2.1 HVAC Testing

2.2 Alarms(Interlock and Critical)

2.3 Air Flow Patterns and flow Rate

2.4 Pressure differential

2.5 Temperatures and Humidity

2.6 Personnel contamination Control

3. Performance Qualification (PQ):

3.1 Testing and Monitoring

3.1.1 Differential pressure

3.1.2 Temperature and humidity

3.1.3 Surface and Airborne Particulate levels

3.1.4 Microbial particulates

Skills: Biotechnology, Engineering, Process Validation, Quality and Reliability Testing

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About the Employer:
( 1 review ) Piscataway, United States

Project ID: #25716240

8 freelancers are bidding on average $110 for this job


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