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 »Template for Process validation protocol
Template for Process validation protocol Objective To provide documented evidence with high degree of assurance that the manufacturing process is capable of producing the finished product consistently of required quality, meeting its predetermined specifications and quality attributes. Scope This process validation protocol is applicable to carry out process validation …
Read More »Installation qualification for pure steam generator
Installation qualification for pure steam generator OBJECTIVE To confirm, by physical inspection and testing, that the fabrication and assembly of the equipment and any auxiliary support systems, conforms to the Design parameters as per the Design Review. SCOPE The tests shall be carried out at customer place. The verification of …
Read More »Slope Verification Procedure for Purified Water Distribution System
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 …
Read More »Operational qualification purified water generation system
Operational qualification purified water generation system The purpose of this protocol (OQ protocol) is to establish confidence that the Purified Water Generation System is capable of operating within these established limits and tolerances with following feature but not limited to: The functional design specification to be address the permanent recording, …
Read More »Protocol for perfomance qualification of water for injection generation, storage and distribution system
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 …
Read More »SOP for sterilization of media.
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 …
Read More »SOP for Cleaning and Sanitization of Drain Point.
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: …
Read More »SOP on Steps to be taken in case of Environmental Failure
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 …
Read More »SOP on Destruction And Disposal of Media Filled Vials
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 …
Read More »SOP on Fumigation in Aseptic Area
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 …
Read More »Cleaning and Sanitization procedure of RO and EDI System of Purified water System
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 : …
Read More »CHEMICAL CLEANING Reverse RO System and EDI System
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 % …
Read More »Cleaning & Passivation Procedure Purified water System
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 ( …
Read More »SOP for cleaning and sanitization of uncontrolled area.
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: …
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