PERFORMANCE QUALIFICATION PROTOCOL FOR CARTON PACKING MACHINE PROTOCOL No.: Prepares the performance qualification protocol. Ensures that the protocol is in compliance with current policies and procedures on system Qualification. Distributes the finalized protocol for review and approval signatures.

The installation qualification must be completed prior to execution of the operational qualification phase. Operational Qualification Operational qualification demonstrates that the installed equipment is functioning within established limits as specified by Helmer. The operational qualification must be completed prior to the execution of the .

OPERATIONAL QUALIFICATION PROTOCOL FOR AUTOMATIC HIGH SPEED LINEAR VIAL WASHING MACHINE-300 Protocol cum Report No.: Batch Size: Page No.: 3 of 19 SCHOLARS QUALITY DEPARTMENT Signing of this Operational Qualification Protocol indicates agreement with the Validation Master Plan approach of the equipment.

Operational qualification Operational qualification (OQ) 13. Operational qualification (OQ) should follow Installation qualification. 3.10 OQ normally follows IQ but depending on the complexity of the equipment it maybe performed as a combined Installation/Operation Qualification (IOQ). OQ could include but is not be limited to the following:

The Installation / Operational / Performance Qualification protocol is a comprehensive document, which will be used to guide the executants, in the verification of the proper installation and operation of the Reefer Truck ID located at Xxxx. 4 OBJECTIVE The purpose of this Installation / Operational / Performance Qualification is to:

BOTTLE PHARMA DEVILS INSTALLATION QUALIFICATION PROTOCOL CUM REPORT FOR WASHING MACHINE PROTOCOL No.: PROTOCOL CONTENTS S.No. TITLE PAGE No. 1.0 Protocol Pre-Approval 3 2.0 Objective 4 3.0 Scope 4 4.0 Responsibility 5 5.0 Equipment Details 6 6.0 System Description 7 7.0 Pre-Qualification Requirements 7 8.0 Critical Variables to be Met 8

OPERATIONAL QUALIFICATION PROTOCOL FOR AUTOMATIC VISUAL VIAL INSPECTION MACHINE Protocol cum Report No.: Batch Size: Page No.: 4 of 20 QUALITY DEPARTMENT 2.0 OBJECTIVE The objectives of this Operational Qualification (OQ) are as follows: To verify that the equipment operates in accordance with the design and user requirements as .

5.D Qualification of water supplies 5.D.1 Introduction 5.D.2 Risk analysis 5.D.3 Design qualification 5.D.4 Installation qualification 5.D.5 Operational qualification (OQ) 5.D.6 Transfer to the user 5.D.7 Process validation/performance qualification (PQ) 5.D.8 Qualification report 5.E Operation of water supplies

An equipment qualification is handled in different phases of the equipment lifecycle, start-ing with design qualification, installation qualification, and then operational qualification and performance qualification. Every step in the equipment qualification formally comprises a plan, the execution and a report.

INSTALLATION QUALI INSTALLATION QUALIFICATION FICATION (1) INSTALLATION INSTALLATION QUALIFICATION QUALIFICATION (1) 1 rue du Petit Clamart - B.P. 50 78142 VELIZY CEDEX - FRANCE Tél. 01.46.29.99.60 - Fax. 01.46.30.87.30 ETUDES & DEVELOPPEMENT VALIDATION C 1/4 NSCA 161/16 LC reference : 37K53E Page Rev. Page Customer reference : 45382135/392 IQ .

8. Installation Qualification, Operational Qualification and Process Qualification page 30 9. Example of Validation Protocol page 33 10. Example of a qualification Proforma page 35 11. Validation sign off report page 50 12. Acknowledgements and Declarations of interest page 51

The objective of this protocol is to define the Installation Qualification (IQ) and Operational Qualification (OQ) requirements and acceptance criteria for the [insert system name and plant number] which will be located in the [insert area, packaging or manufacturing] at site [insert site name].

exempting qualification. B Structure of the qualification The structure of the qualification and syllabus subjects is shown on the following diagram. C Progression through the qualification Subjects within each learning pillar of the qualification are designed to be sequential, from operational to strategic level, encouraging

The Installation / Operational / Performance Qualification protocol is a comprehensive document, which will be used to guide the executants, in the verification of the proper installation and operation of the Refrigerator located at Xxxxx. 4 OBJECTIVE The purpose of this Installation / Operational / Performance Qualification is to:

The Installation / Operational / Performance Qualification protocol is a comprehensive document, which will be used to guide the executants, in the verification of the proper installation and operation of the Cold Room located at Xxxxxx. 4 OBJECTIVE The purpose of this Installation / Operational / Performance Qualification is to:

The operational qualification serves as proof that the equipment operates as designed and intended as well as fulfills acceptance criteria defined and stated in the Operational Qualification documentation. These criteria are defined and are based on the equipment technical specifications of the manufacturer.

Installation Qualification and Operational Qualification Miris Ultrasonic Processor COMPANY CONFIDENTIAL FORM-943 Installation Qualification and Operational Qualification Miris Ultrasonic Processor Version: 1 Page 1 of 13 Figure 1. The Miris Ultrasonic Processor 1. Sound reducing cabinet 2. Power supply unit

covers the three stages of qualification needed to release a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Related topics are covered in the following Technical Supplements: Temperature mapping of storage areas.

Operational Qualification section. Labconco Purifier Logic Series BSC’s IQ/OQ/PQ Protocol #1058603 Revision A 3 A. Installation Qualification Step Description Specification or Acceptance Criteria Result YES NO 1 Site Planning 1a Proper airflows Is the Purifier Logic to be located in a room .

investigate the behaviour and transient response of a fuel cell system for automotive applications. Fuel cell dynamics are subjective to reactant flows, heat management and water transportation inside the fuel cell. Therefore, a control-oriented model has been devised in Aspen Plus Dynamics, which accommodates electrochemical, thermal, feed flow and water crossover models in addition to two .