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Performance Qualification(PQ)

Performace Qualification Protocol of Dispensing Booth

Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …

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Performance Qualification for Automatic Strip Packing Machine

Performance Qualification for Automatic Strip Packing Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Sealing Temperature 6.2 Effect …

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Performance Qualification for Auto Coater 48’’ GMP Model

TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Gun Distance from Bed 6.2 RPM of Peristaltic pump and Spray Rate 6.3 …

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Performance Qualification for Tablet Compression Machine

Performance Qualification for Tablet Compression Machine TABLE OF CONTENTS 1.0 Approval 2.0 Objective 3.0 Responsibility 4.0 System Description 4.1 Equipment Identification 4.2 Description of Operation 4.3 Standard Operating Procedure Established During Operation Qualification 5.0 Validation Plan and Methodology 6.0 Performance Qualification Procedure 6.1 Effect of Machine Speed 6.2 Effect of …

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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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