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Performance Qualification(PQ)

PERFORMANCE QUALIFICATION PROTOCOL

PERFORMANCE QUALIFICATION PROTOCOL TABLE OF CONTENTS 1.0       PROTOCOL APPROVAL 2.0       OBJECTIVE 3.0       SCOPE 4.0       RESPONSIBILITY 5.0       ACCOUNTABILITY 6.0       METHOD 7.0       RECORDING 8.0       ABBREVIATIONS 9.0       REFERENCES. 10.0     REVISION OF PROTOCOL   1.0     PROTOCOL APPROVAL: Protocol Prepared by: QA is responsible for the preparation of protocol for Performance Qualification of Nitrogen plant. …

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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 sealing of the different type of …

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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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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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Protocol for perfomance qualification (PQ) of water for injection generation, storage and distribution system

Protocol Approval This is a specific protocol for Performance Qualification of Water for Injection generation, Storage, Distribution System, which is located in the first floor of the production department. This protocol has been approved by the following:                     Name  Department  Signature   Date Prepared By         …

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Performance Qualification Protocol of Tunnel Sterilizer

Equipment Name: TUNNEL STERILIZER DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE   TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description 5.0 Responsibilities And Identification Of Execution Team 6.0 Test Procedures 7.0 Recording …

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PERFORMANCE QUALIFICATION PROTOCOL OF WATER FOR INJECTION GENERATION AND DISTRIBUTION SYSTEM

  Document No. Supersedes Effective Date Review Date No. of Pages Reference Protocol No. Protocol Contents 1.0 Protocol Approval  2. Overview 2.1Objective:  2.2 Purpose and Scope 2.3 Responsibility 2.4 Qualification Team 3.0 Traning Record 3.1 Purpose 3.2 Scope 4.0 Performance Qualification Requirements 5.0 System / Equipment Description 5.1 System / …

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Performance Qualification Protocol of TUNNEL STERILIZER

DEPARTMENT PRODUCTION NAME OF THE SUPPLIER MODEL SERIAL NUMBER LOCATION VIAL WASHING ROOM EFFECTIVE DATE   CHANGE HISTORY Date Supersede CCR No. Changes Made Revision No. Nil NA Original Issue 00   TABLE OF CONTENTS S. No. Description Page No. 1.0 Protocol Approval 2.0 Objective 3.0 Scope 4.0 System Description …

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PERFORMACE QUALIFICATION PROTOCOL OF DISPENSING BOOTH

TABLE OF CONTENT Description Page No Performance Qualification Protocol Approval Objective Scope Responsibility Pre requisite Reference  Testing Procedure   ·                     Airflow Laminarity by Smoke Test ·                     Non viable particle count ·                     Viable particle count Performance qualification summary and conclusion Abbreviation Performance Qualification Approval Particle count test report sheet    Viable …

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