Dust control during AHU design in Pharma Company Dust control in Pharma Company in measure challenge Wherever possible, dust or vapour contamination should be removed at source. Point-of-use extraction, i.e. as close as possible to the point where the dust is generated, should be employed. Spot ventilation or capture hoods may be used as appropriate. Point-of-use … Read more
SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT INTRODUCTION: The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design (QbD) is emerging to enhance the assurance of … Read more
Preparation, hahdling, storage and discard of mobile phases OBJECTIVE To lay down a procedure for the preparation , handling , storage and discard of mobile phases. SCOPE This SOP shall be applicable for preparation , handling , storage and discard of mobile phases. RESPONSIBILITY Executive/Officer – Quality control ACCOUNTABILITY Head – Quality Assurance Procedure for … Read more
FACILITY VALIDATION PROTOCOL To ensure that the Facility installed, for the Production Granulation area conforms with the predetermined acceptance criteria. SCOPE OF FACILITY VALIDATION PROTOCOL: – To perform the Facility validation for Production Granulation area. RESPONSIBILITY: – Validation Executive Engineering Executive Production Executive PROCEDURE: – Check the facility as per acceptance criteria in granulation area … Read more
SOP Operational Qualification of Raw Gelatin Storage Vessel PURPOSE: To describe the Operational 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 Operational/Design limits as per user requirements. ensure that the equipment shall be operationally qualified in accordance with … Read more
SOP For Design Qualification of Raw Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the Raw Gelatin Storage Vessel and to provide assurance that the machine is manufactured 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 … Read more
SOP For Installation Qualification of Encapsulation Machine PURPOSE To describe the Installation Qualification of Encapsulation Machine along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the Specification of the system in order to: ensure that the equipment meets the specification as Design Qualification aid verification of the installation as per equipment … Read more
Facility Validation in pharmaceutical Pharma Company Facility qualification (a part of validation that proves and documents that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results), and validation (establishing documented evidence that provides a high degree of assurance that the manufacturing processes, including buildings, systems, and equipment consistently … Read more
How to face Interview Remember, you never get a second chance to make a good first impression. However, good preparation takes the pain out of the process. Interview Preparation Remember: Prepare, prepare, prepare! Preparation is essential and greatly enhances your chances of performing well, So: know your CV know your potential employer understand commonly used … Read more
SOP for Operational qualification protocol of Blister Packing Machine (BQS) PURPOSE To describe the Operational Qualification procedure to be used during qualification of Blister Packing Machine (BQS), its accessories and to define the specification of the sytem in order to: Ensure that the equipment meets the Operational/Design limits as per user requirements Ensure that the … Read more
SOP For Design Qualification of Colloid Mill OBJECTIVE To design, engineer, and supply the Colloid Mill and to provide assurance that the machine is manufactured and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there in the document, are the same … Read more
SOP For Installation qualification of 300 L Gelatin Melting Reactor PURPOSE: To describe the Installation Qualification of 300 L Gelatin Melting Reactor 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 … Read more
SOP for Design Qualification of Blister Packing Machine (Model – BQS) OBJECTIVE To design, engineer, and supply the Blister Packing Machine (Model: BQS) and to ensure that it complies with the Scope of Supply. To prove that each operation proceeds as per the design specification and the tolerances prescribed there in the document are the … Read more
SOP for Sampling of In-process blends, uncoated tablets, coated tablets and filled capsules OBJECTIVE : To provide a procedure for representative sampling of In-process blends, uncoated tablets, coated tablets and filled capsules. RESPONSIBILITY : Officer – Quality Assurance. Head – Quality Assurance to ensure compliance. PROCEDURE : After receiving the “Inprocess Analysis Request and report … Read more
Installation qualification of Blister Packing Machine (Hoonga) PURPOSE To describe the Installation Qualification procedure to be used during qualification of Blister Packing Machine (Hoonga), its accessories and to define the Specification of the system in order to Ensure that the equipment meets the specification as Design Qualification. Aid verification of the installation as per equipment … Read more
SOP for Operational qualification protocol of Gelatin Melting Reactor PURPOSE: To describe the Operational Qualification of 300 L Gelatin Melting Reactor, 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 … Read more
SOP for Operational Qualification of Capsule Printing Machine PURPOSE: To describe the Operational Qualification of Capsule Printing Machine its accessories and to define the specification of the system in order to: ensure that the machine meets the Operational / Design limits as per user requirements ensure that the machine will be operationally qualified in accordance … Read more
SOP for Design Qualification of Capsule Printing machine OBJECTIVE To design, engineer, and supply the Capsule Printing Machine and to provide assurance that the machine is manufactured as per the URS and it comply with the Scope of Supply. To prove that each operation proceeds as per the design qualification and the tolerances prescribed there … Read more
SOP for Installation Qualification of Capsule Printing machine PURPOSE To describe the Installation Qualification of Capsule printing machine, 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 … Read more
SOP FOR OPERATIONAL QUALIFICATION of Soft Gelatin Encapsulation System PURPOSE To describe the Operational Qualification of Arbes Encapsulation System (CAP-X-8) along with Tumble Dryer and Gravity Feed Pipes, its accessories and to define the specification of the system in order to: ensure that the equipment meets the Operational/Design limits as per users requirements. ensure that … Read more
