Transfer the required quantity of seals from warehouse to decartoning room on the receipt of the packing material requisition slip. Decartoning of Seal Decartoning of Rubber Stopper Transfer the required quantity of stopper from warehouse to decartoning room on the receipt of the packing material requisition slip. The production officer …
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 »Preparation of Validation and Qualification Protocols
Preparation of Validation and Qualification Protocols Objective To lay down a procedure for Preparation of Validation and Qualification protocols applicable to all aspects of manufacturing processes, equipments, control systems (including computer hardware and software), utilities, facility, temperature mapping, Shipping and any significant changes to the above mentioned elements which may …
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 »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 »Hydro Testing Procedure for Purified Water Distribution Loop and Purified Water Storage Tank
Hydro Testing Procedure for Purified Water Distribution Loop Objective : To ensure that the Purified Water Distribution Piping is Leakage proof from TC joints & Orbital Weld joints. Scope :Applicable for Hydro Testing of Purified Water Distribution Loop Procedure : Fill the Purified Water Distribution piping loop completely with Purified …
Read More »Passivation and Cleaning Procedure Purified Water Distribution Loop
Objective : To ensure that the Purified Water Distribution System is Chemically cleaned. Scope :Applicable for Passivation and Cleaning of Purified Water Distribution Loop Procedure : Fill the Purified Water Storage Tank till the Half Level. Ensure Suction & Discharge valve of pump are open and all user points & sampling …
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 »Boroscopy Examination Procedure for Purified water system
Objective : To take the photographs of pipe weld joints made by fusion of base material without the addition of filler and recorded in the attached compact disc and should meeting the required specifications mentioned below. Uniformity in weld joint. Should have proper penetration. Should not have any foreign object …
Read More »Orbital Welding Procedure for purified water system
Orbital Welding Procedure for purified water system Objective : To get more consistent root weld beads and weld overrun, pinholes should be absent. Scope :This SOP is applicable for Orbital Welding of purified water system Procedure : Ensure the welder is qualified before starting of welding. Clamp the welding head at …
Read More »