Equipment Qualification Protocols

1.0 Objective

The objective of this Installation Qualification Protocol is to define the requirements and acceptance criteria required to generate documented evidence for satisfactory installation of Rapid Mixer Granulator, installed in Production area,

This protocol aims to provide an outline for the inspection of equipment for static attributes to verify that:

• Each installed sub-component complies with the requirement specification(s).

• SOPs have been identified and listed

• All critical instrumentation has been identified for calibration of the equipment.

• All supporting utilities are properly connected.

• The system installation meets acceptance criteria.

2.0 Scope

The scope of this Installation Qualification Protocol is limited to the Rapid Mixer Granulator, installed in Production area.

5.0 Installation Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective

The objective of this Installation Qualification Protocol is to define the requirements and acceptance criteria required to generate documented evidence for satisfactory installation of Egg shell blender, installed in Production area,

This protocol aims to provide an outline for the inspection of equipment for static attributes to verify that:

• Each installed sub-component complies with the engineering design and equipment data sheet/ specification.

• The system is installed according to the design specification and manufacturer’s recommendation.

• The system meets the cGMP and all other regulatory requirement.

• No unauthorized and unrecorded modification has taken place.

• SOPs have been identified and listed

• All critical instrumentation has been identified for calibration of the equipment.

• All supporting utilities are properly connected.

• All testing reports are available and maintained on file 

• Ensure that the system installation meets acceptance criteria.

2.0 Scope

The scope of this Installation Qualification Protocol is limited to the Egg shell blender, installed in Production area.

5.0 Installation Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective

The objective of this Installation Qualification Protocol is to define the requirements and acceptance criteria required to generate documented evidence for satisfactory installation of Compression Machine, installed in Production area,

This protocol aims to provide an outline for the inspection of equipment for static attributes to verify that:

• Each installed sub-component complies with the requirement specification(s).

• SOPs have been identified and listed

• All critical instrumentation has been identified for calibration of the equipment.

• All supporting utilities are properly connected.

• The system installation meets acceptance criteria.

2.0 Scope

The scope of this Installation Qualification Protocol is limited to the Compression Machine, installed in Production area.

5.0 Installation Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective

The objective of this Installation Qualification Protocol is to define the requirements and acceptance criteria required to generate documented evidence for satisfactory installation of Auto Coating Machine, installed in Production area,

This protocol aims to provide an outline for the inspection of equipment for static attributes to verify that:

• Each installed sub-component complies with the requirement specification(s).

• SOPs have been identified and listed

• All critical instrumentation has been identified for calibration of the equipment.

• All supporting utilities are properly connected.

• The system installation meets acceptance criteria.

2.0 Scope

The scope of this Installation Qualification Protocol is limited to the Auto Coater Machine, installed in Production area.

5.0 Installation Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective

The objective of this Installation Qualification Protocol is to define the requirements and acceptance criteria required to generate documented evidence for satisfactory installation of Fluid Bed Dryer, installed in Production area,

This protocol aims to provide an outline for the inspection of equipment for static attributes to verify that:

• Each installed sub-component complies with the requirement specification(s).

• SOPs have been identified and listed

• All critical instrumentation has been identified for calibration of the equipment.

• All supporting utilities are properly connected.

• The system installation meets acceptance criteria.

2.0 Scope

The scope of this Installation Qualification Protocol is limited to the Fluid Bed Dryer, installed in Production area.

5.0 Installation Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective

To describe the Operational Qualification of Fluid Bed Dryer, its accessories and to define the specification of the system in order to:

1. Ensure that the equipment meets the Operational/Design limits.

2. Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices

2.0 Scope

The scope of this document applies to the operational qualification of Fluid Bed Dryer and its accessories to be installed in granulation area.

5.0 OPERATIONAL Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 Objective 

Purpose of this protocol is to validate the above equipment for the operational qualification to:

• Demonstrate that the equipment / system will perform reproducibly and consistently within its full range of operation according to manufacturer’s specification.

• Document the initial performance of equipment / system for future reference.

• Assure that the equipment / system performance is adequate to support the process for which the system is intended.

• Demonstrate that the suitability of the SOP is established for the equipment / system

2.0 Scope

The scope of this document applies to the operational qualification of Rapid Mixer Granulator and its accessories to be installed in granulation area.

5.0 OPERATIONAL Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more and Download

1.0 OBJECTIVE:

The objective of this protocol is to be described the procedure and plan for validation of washing of different sizes of glass vials using vials washing machine and to demonstrate that vials washing machine shall perform washing of different sizes of glass vials which meets the desired meet acceptance criteria in a consistent manner when operated as per the standard operating procedure.

2.0 SCOPE:

The scope of this validation is limited to the validation of vial washing process for different sizes of glass vials.

6.0 Performance qualification test shall include following test:

6.1 Performance Qualification Test Matrix

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1.0 Objective

To describe the Operational Qualification of Double Cone Blender and to define the specification of the system in order to:

• Ensure that the equipment meets the Operational/Design limits.

• Demonstrate that the equipment / system will perform reproducibly and consistently within its full range of operation according to manufacturer’s specification

• Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices

• Assure that the equipment / system performance is adequate to support the process for which the system is intended.

• Demonstrate that the suitability of the SOP is established for the equipment / system

2.0 Scope

The scope of this document applies to the operational qualification of Double Cone Blender installed in granulation area.

5.0 Operational Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

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1.0 Objective

      To describe the Operational Qualification of Compression Machine and to define the specification of the system in order to:

• Ensure that the equipment meets the Operational/Design limits.

• Demonstrate that the equipment / system will perform reproducibly and consistently within its full range of operation according to manufacturer’s specification

• Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices

• Assure that the equipment / system performance is adequate to support the process for which the system is intended.

• Demonstrate that the suitability of the SOP is established for the equipment / system

2.0 Scope

The scope of this document applies to the operational qualification of Compression Machine installed in Compression Area.

5.0 Operational Qualification Test Matrix

The following test(s) / verifications must be completed successfully for a satisfactory

For Complete Protocol- Click on Read more, Subscribe and Download