1 Pharmaceutical Quality System (PQS)
1 Pharmaceutical Quality System (PQS)
2 Personnel
2 Personnel
3 Premises
3 Premises
4 Facilities and Equipment
4 Facilities and Equipment
5 Pharmaceutical Water
5 Pharmaceutical Water
6 Qualification
6 Qualification
6.A Official requirements and agency expectations
6.A Official requirements and agency expectations
6.B Activities for the preparation of a qualification
6.B Activities for the preparation of a qualification
6.C Qualification documentation
6.C Qualification documentation
6.D Design Qualification (DQ)
6.D Design Qualification (DQ)
6.E Installation Qualification (IQ)
6.E Installation Qualification (IQ)
6.F Operational Qualification (OQ)
6.F Operational Qualification (OQ)
6.G Performance Qualification (PQ)
6.G Performance Qualification (PQ)
6.G.1 Purpose and Scope of a Performance Qualification
6.G.1 Purpose and Scope of a Performance Qualification
6.G.2 Performance Qualification in the Course of the Project
6.G.2 Performance Qualification in the Course of the Project
6.G.3 Execution and Documentation of a PQ
6.G.3 Execution and Documentation of a PQ
6.G.4 Example of a Performance Qualification of a Filling Line
6.G.4 Example of a Performance Qualification of a Filling Line
Summary
Summary
6.H Qualification by third party
6.H Qualification by third party
6.I The qualification life cycle
6.I The qualification life cycle
6.J Example SOP for the qualification of equipment and machinery
6.J Example SOP for the qualification of equipment and machinery
6.K References
6.K References
7 Process Validation
7 Process Validation
8 Cleaning Validation
8 Cleaning Validation
9 Computer System Validation
9 Computer System Validation
10 Quality Risk Management
10 Quality Risk Management
11 Production
11 Production
12 Sterile Production
12 Sterile Production
13 Packaging
13 Packaging
14 Laboratory Controls
14 Laboratory Controls
15 Documentation
15 Documentation
16 Research and Development
16 Research and Development
17 Contractors and Suppliers
17 Contractors and Suppliers
18 Inspections
18 Inspections
19 Quality Unit
19 Quality Unit
20 Continual Improvement
20 Continual Improvement
21 Active Pharmaceutical Ingredients
21 Active Pharmaceutical Ingredients
22 Excipients
22 Excipients
23 Medical Devices
23 Medical Devices
24 Storage and Transportation
24 Storage and Transportation
as of 2018 - 09 - 17

6.G Performance Qualification (PQ)

6.G Performance Qualification (PQ)
Here you will find answers to the following questions:
●

What is meant by the term “PQ”?
●

Which regulatory requirements must be considered?
●

What kinds of tests are performed during a PQ?
●

When should a PQ be performed?
6.G Performance Qualification (PQ)
Summary
6.G.1 Purpose and Scope of a Performance Qualification
6.G.2 Performance Qualification in the Course of the Project
6.G.3 Execution and Documentation of a PQ
6.G.4 Example of a Performance Qualification of a Filling Line

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