Validation & Qualification

Validation & Qualification

SOP For Design Qualification of Colloid Mill

SOP For Design Qualification of Colloid Mill OBJECTIVE To design, engineer, and supply the Colloid Mill and to provide assurance that the machine is manufactured and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in …

Read More »

SOP For Installation qualification of 300 L Gelatin Melting Reactor

SOP For Installation qualification of 300 L Gelatin Melting Reactor PURPOSE: To describe the Installation Qualification of 300 L Gelatin Melting Reactor its accessories and to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Aid verification of the …

Read More »

SOP for Operational qualification protocol of Gelatin Melting Reactor

SOP for Operational qualification protocol of Gelatin Melting Reactor PURPOSE: To describe the Operational Qualification of 300 L Gelatin Melting Reactor, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per user requirements. ensure that the equipment …

Read More »

Installation qualification for WFI generation plant

Installation qualification for WFI generation plant  RESPONSIBILITES Inspection  Customer or their authorized representatives are responsible for this SAT document. All documents shall be checked and approved by QA or their authorized representatives. Production personal will perform this test. OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and …

Read More »

Operation qualification protocol for air handling unit & air distribution system

Operation qualification protocol for air handling unit & air distribution system Purpose: The purpose of this protocol is: To verify the operational attributes of the Heating Ventilation and Air Conditioning system, critical to serve the intended purpose. To establish the suitability of the draft SOP prepared for the operation of …

Read More »

Installation qualification protocol for air handling unit & air distribution system

Installation qualification protocol for air handling unit & air distribution system OBJECTIVE The objective of this protocol is to provide an outline for the inspection of static attributes, written procedure and  guidelines and respective acceptance criteria for the Installation and Operational Qualification of Air handling unit . The Air-Handling unit …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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

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 …

Read More »

Operational qualification for pure steam generator

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) …

Read More »

Template for Performance Qualification Protocol

Performance 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 …

Read More »

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 …

Read More »

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., …

Read More »

Template of Operatinal Qualification Report

Operational 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 …

Read More »

Template for Operational Qualification Protocol

Operational 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 …

Read More »

PQ of WFI generation, storage and distribution system

PQ of WFI 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 …

Read More »

Template for Installation Qualification Protocol

Template for Installation Qualification Protocol PURPOSE To describe the Installation Qualification procedure to be used during qualification of Name of Equipment machine to define the Specification of the system in order to Ensure that the equipment meets the specification as per Design Qualification (Doc Number). Aid verification of the installation …

Read More »

Template for User Requirement Specification (URS)

Tamplate for User Requirement Specification TECHNICAL Specifications S. No. Parameters Required Specifications 1. 1.1 1.2 1.3 1.4 1.5  General Equipment No. Description Use Field Identification Glossary             2. 2.1   2.2 2.3 2.4 Salient Features General   Material of Construction Finish Electrical Construction   Smooth  Finish/matt …

Read More »

Template for Design Qualification Protocol

Template for Design Qualification Protocol OBJECTIVE To design, engineer, and supply the Name of Equipment and to provide assurance that the machine is manufactured as per the URS:  Doc Number and it complies with the Scope of Supply. To prove that each operation proceeds as per the design qualification and …

Read More »