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Validation & Qualification

Cleaning Validation Protocol

Cleaning Validation Protocol CONTENTS S. No. Topic Page No. 1.0 Protocol Preparation and Approval Sheet 2.0 Objective 3.0 Scope 4.0 Responsibility 5.0 Validation Team 6.0 Abbreviations and Definitions 7.0 Cleaning Validation Approach 7.1 Selection of Products 7.2 Selection of Equipments 7.3 Type  Cleaning after every five consecutive batches of the …

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Performance Qualification Protocol. Vial sealing machine

Performance Qualification Protocol. Vial sealing machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial sealing Machine. To demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and suitable for …

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Performance Qualification Protocol for Vial Filling Machine

Performance Qualification Protocol for Vial Filling Machine OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the Vial Filling Machine. To Demonstrate that the equipment / system is performing reproducibly and consistently within its operating range of operation and fill …

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Performance Qualification Protocol. P.H.V. Steam Sterilizer

OBJECTIVE The objective of this Validation Protocol is to obtain a high degree of assurance that the steam sterilization process is capable of sterilizing the specified loads using High Pressure and High Vacuum Steam Sterilizer (Bung Processor). To establish a documented evidence that the Steam sterilizer, as commissioned, will produce …

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Operational qualification for pure steam generator

OBJECTIVE To establish documentary evidence to demonstrate the Pure Steam Generator  system is qualified for correct operation as per guidelines outlined in this protocol & operational manual. SCOPE OF THIS DOCUMENT This protocol is applicable to pure steam generator. Functional testing (including safety tests) of the equipment with printouts for …

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Template for Performace Qualification Protocol

OBJECTIVE To describe the Performance Qualification procedure to be used during qualification of NAME OF THE EQUIPMENT system in order to: Ensure the system reproducible over an appropriate time period as per user requirement specifications Ensure that the system is showing consistency in producing Product of pre-established specifications. SCOPE This …

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Template for Mapping of the Environmental condition

Template for Mapping of the Environmental condition Objective The objective of this validation study is to provide a document evidence of Temperature and Relative Humidity distribution in Ware House area against predetermined acceptance criteria. Scope The validation study of the Temperature and Relative Humidity distribution in Ware House area shall …

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Template Protocol for Shipping validation

Objective The objective of this study is to establish a procedure to records temperature data to ensure that transportation conditions have not adversely affected a products, when transported as per regular Shipment practice. Scope The Shipping (Transportation) validation study shall be carried out for four times covering four seasons viz., …

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Template of Operatinal Qualification Report

PURPOSE To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to: Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices Ensure that the equipment meets the Operational/Design limits as per user requirements. SCOPE …

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Template for Operatinal Qualification Protocol

PURPOSE To describe the Operational Qualification of Name of the Equipment and to define the specification of the system in order to: Ensure that the equipment will be operationally qualified in accordance with current Good Manufacturing Practices Ensure that the equipment meets the Operational/Design limits as per user requirements. SCOPE …

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