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Validation & Qualification

Installation qualification for puriffied water generation system

Purpose  The purpose of this protocol is to provide an outline for the inspection of the system for static attributes to verify that: Each installed sub-component complies with the engineering design and system data sheets/specifications. The system is installed according to the design specifications and manufacturer’s recommendations The system meets …

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Operational Qualification of Vertical Laminar Reverse flow Containment Station

PURPOSE: To describe the Operational Qualification of Vertical Laminar Reverse flow Containment Station, 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 will be operationally qualified in accordance with current …

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Installation Qualification of Vertical Laminar Reverse Flow Containment Station

PURPOSE To describe the Installation Qualification of Vertical Laminar Reverse Flow Containment Station 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 installation as per equipment general arrangement drawing. Ensure that the system …

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Operational Qualification of Medicament Preparation Vessel

PURPOSE: To describe the Operational Qualification of Medicament Preparation Vessel, 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 shall be operationally qualified in accordance with current Good Manufacturing Practices. …

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Installation Qualification of Raw Gelatin Storage Vessel

PURPOSE: To describe the Installation Qualification of Raw Gelatin Storage Vessel 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 installation as per equipment general arrangement Drawing. Ensure that the system …

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Installation Qualification of Aluminium Strip Defoiler

PURPOSE To describe the Installation Qualification procedure to be used during qualification of Aluminium Strip Defoiler to define the Specification of the system in order to: Ensure that the equipment meets the specification as per Design Qualification. Ensure that the system installation meets acceptance criteria Ensure that the equipments will …

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Alu Alu Blister Pack Machine

Alu Alu Blister Pack Machine Sr. No. Table of Contents 1 General 2 Salient Features 3 Operational Requirements 4 Utilities 5 Maintenance 6 Commissioning and Documentation 7 Training 8 Packaging 9 Deviations 10 Delivery TECHNICAL  S. No. Parameters Required Specifications 1.        General  Equipment No. Description Use   Field Identification …

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Process Validation Guidances: FDA and Global

Process Validation Guidances: FDA and Global   OUTLINE Process Validation Lifecycle Approach Overview History and development Is the lifecycle approach really new? FDA commentary Lifecycle Approach Stages 1 — Process Understanding (Process Design) 2 — Process Demonstration (Process Qualification) 3 — Maintaining Validation (Continued Process Verification) Fundamental Concepts The “process …

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New EU Requirements for Qualification & Validation

  Updated version of Annex 15 ◦ Qualification and Validation Draft released in February 2014 Final version released on the 30th of March , 2015 Will be effective on 01 October 2015 4/3/2015 3 Improved Annex 15 May be used as supplementary optional guidance for active substances without introduction of …

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Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification

Concept of URS,Design Qualification,Installation Qualification,Operational Qualification,Performance Qualification Introduction  Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish …

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