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 user requirements. SCOPE The scope…
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 user requirements. SCOPE The scope…
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WFI generation, storage and distribution system Brief Instrument Description: The Water For Injection System Still is working on the Principle of inters stage heat exchange (Reuse of energy) drastically reduce the consumption of heat energy and cooling water. Thus enable to produce large- scale of Pyrogen free sterile water for injection. The Distillation Column operates…
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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 as per equipment general arrangement…
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Template for User Requirement Specification TECHNICAL SPECIFICATION General Equipment No. Description Use Field Identification Glossary Salient Features General Material of Construction Finish – Smooth Finish/matt finish/mirror finish Electrical Construction – Non flameproof / flameproof Operational requirements Capacity Control Parameter Desired Accuracy Control Data & Security User interface with supervisors and operators for the control platform Interface…
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Template for Design Qualification Protocol 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 the tolerances prescribed there in the…
Template for Process validation protocol To provide documented evidence with a high degree of assurance that the manufacturing process is capable of producing the finished product consistently of the required quality, meeting its predetermined specifications and quality attributes. Scope: This process validation protocol is applicable to carry out process validation of the Name of the…
Installation qualification for pure steam generator To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and any auxiliary support systems, conform to the Design parameters as per the Design Review. SCOPE The tests shall be carried out at the customer’s place. The verification of compliance to specifications as per…
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Slope Verification Procedure for Purified Water Distribution System Objective : To ensure that the distribution lines are sloped towards the point of use and slope of the lines is approximately 1mm in 100 mm. Scope :Applicable for Slope Verification of Purified Water Distribution System Procedure Collect the As Built Isometric Drawing of the PW Distribution System….
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Water generation system Operational qualification The purpose of Operational Qualification is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with the following features but not limited to: The functional design specification addresses the permanent recording, visual indication, design/specification range, normal operating range, alert and alarm…
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Protocol for perfomance qualification of water for injection generation, storage and distribution system Objective: To establish the methodology for the Performance Qualification of WFI Generation, Storage and Distribution system , which produces pyrogen free, water for injection, used as a Sterile products manufacturing facility. Purpose and Scope The purpose of this Protocol is to establish…
SOP for sterilization of media. Objective: To lay down a procedure for sterilization of media. Scope: This SOP is applicable for sterilization of media. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head and QA Head shall be accountable for the compliance of SOP. Abbreviations…
SOP for Cleaning and Sanitization of Drain Point. Objective: To lay down a procedure for cleaning and sanitization of drain point. Scope: This SOP is applicable for cleaning and sanitization of drain point. Responsibility: Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability: Production Head and QA head…
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Objective To lay down the steps to be taken in case of environment failure in the aseptic area of Sterile Dry Powder Injectables facility. Scopе This SOP describes the steps to be taken in case of environmental failure. Responsibility Production Officers / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability…
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SOP on Destruction And Disposal of Media Filled Vials Objective: To lay down a procedure on destruction and disposal of media filled vials. Scope This SOP is applicable for destruction and disposal of media filled vials. Responsibility Production officer / Executive shall be responsible for follow the procedure mentined in this SOP. Accountability Production Head…
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Objective To lay down a procedure for fumigation in aseptic area. Scope The SOP describes the procedure for fumigation in aseptic area. Responsibility Production Officer / Executive shall be responsible for follow the procedure mentioned in this SOP. Accountability Production Head and Qa head shall be accountable for compliance of SOP. Abbreviations QA: Quality Assurance…
CLEANING AND SANATIZATION (PASSIVATION) REPORT SYSTEM: PURIFIED WATER GENERATION SYSTEM Objective: The system needs cleaning and sanitization before start of the plant and loading of RO membrane to remove any microbial load or any bio film present in the existing interconnecting piping and the RO Housing and Pumps. Procedure : The sanitization has to be…
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CHEMICAL CLEANING Reverse RO System and EDI System RO CLEANING – CITRIC ACID Preparation of Cleaning solution: Prepare a solution of 2% (By weight) of Citric acid (C6H8O7). This is useful in removing of inorganic scales and organic based colloidal material. Recommended quantity is 7.7 kg Citric acid (100 % powder) which is to be…
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Cleaning & Passivation Procedure Purified water System Fill the Storage Tank upto the Half Level & Start the recirculation pump & circulate water for 25-30 minutes Then drain the water from the Tank & piping ( Via User Points, & Sampling Points.) Prepare cleaning chemical by diluting Sodium Hydroxide ( NaOH) ( of 100% Purity)…
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SOP for cleaning and sanitization of uncontrolled area. Objective: To lay down a procedure for cleaning and sanitization uncontrolled area. Scope: This SOP is applicable for cleaning and sanitization of uncontrolled area. Responsibility: Officers or above – Production. Accountability: Production Head. Abbreviations SOP : Standard Operating Procedure. Ltr.: Liter Procedure: Uncontrolled area are primary packing…
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