Tag Archives: Myaanmar (Burma)

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 …

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the BUNG WASHING MACHINE. To verify the Rubber stopper washing process is capable of consistently and reliably removing Particulate matter contaminants, such as dust, lint, fibres etc., Bacterial Endotoxins, from the …

OBJECTIVE To establish documented evidence which will provide a High degree of assurance and reliability about the performance of the VERTICAL ROTARY VIAL WASHING MACHINE. To verify the vial washing process is capable of consistently and reliably producing appropriate washing of different types of vials at different speeds encountered in …

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 …

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 …

Objective: To lay down a procedure for operation of BOPP taping machine. Scope This SOP is applicable for operation of BOPP taping machine. Responsibility Officers or above – Production. Accountability Production Head. Abbreviations SOP : Standard Operating Procedure. BOPP : Biaxial Oriented Polypropylene IPQA : In-process Quality Assurance Procedure Pre-Start …

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 …

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 …

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) …

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 …

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 …

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., …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …