Each guideline includes all the test procedures and data sheets necessary for generating IQ and OQ protocols for the system listed.   Many guidelines can also generate PQ protocols.
 

ID Number

Description

40

Utilities

Utils-4010

Purified Water Systems

Utils-4020

Water for Injection Systems

Utils-4030

HVAC Systems

Utils-4040

Compressed Gas (Nitrogen, Air) Systems

Utils-4041

Oil-Free Compressed Air Systems

Utils-4050

Clean Steam Systems

Utils-4060

Environmental Control Rooms

Utils-4070

SIP/SOP Systems

Utils-4080

CIP/COP Systems

Utils-4090

Chilled Glycol Systems
   

50

Equipment – General

Equipt-5005

 Filter Integrity Tester 

Equipt-5010

Steam Autoclaves

Equipt-5020

Bin Washers

Equipt-5030

Depyrogenation Ovens

Equipt-5040

Depyrogenation Tunnels

Equipt-5050

Lyophilizers

Equipt-5060

Incubators / Refrigerators / Freezers

Equipt-5070

Tanks 

Equipt-5080

Chemical Reactors 
Equipt-5090 Vial Washers
   

60

Equipment – Solid Dosage

SolDos-6010

Granulators

SolDos-6020

Blenders

SolDos-6030

Fluid Bed Dryers

SolDos-6040

Tabletting Machines

SolDos-6050

Tablet Coaters

SolDos-6060

Encapsulators
   

70

Equipment – Biotech

Biotec-7010

Ultrafiltration / Diafiltration

Biotec-7020

Bioreactors

Biotec-7030

Centrifuges

Biotec-7040

Chromatography Systems
Biotec-7050 Biotech Processes
   

80

Filling and Packaging Lines

FilPak-8010

Filling Lines

FilPak-8020

Solid Dosage Packaging Line

FilPak-8030

Inspection Systems

FilPak-8040

Stopper Processors

FilPak-8050

Labeling Equipment

FilPak-8060

Capper / Sealer Systems 
FilPak-8070 Blister Packaging Lines
   

85

Laboratory Systems

LabSys-8510

Laboratory Chromatography Systems 

LabSys-8520

Gel Electrophoresis Systems

LabSys-8530

Ion Chromatography Systems

LabSys-8540

Osmometer Systems

LabSys-8550

Fluorometer Systems

LabSys-8560

Spectrophotometer Systems

LabSys-8570

Dissolution Test Systems
   

90

Computer and Control Systems

CmpCtl-9020

PLC / SCADA Systems

CmpCtl-9030

Distributed Control Systems
CmpCtl-9040 IS/IT Systems

CmpCtl-9080

Building Management Systems
   

95

Medical Device

MedDev-9570

 Injection Molding Systems 

MedDev-9580

 Welding Systems 
   
  Miscellaneous
Master-0010 Facility Validation Master Plan
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