Design Qualification of Medicament Preparation Vessel OBJECTIVE: To design, engineer and supply the Medicament Preparation 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 …

PURPOSE To describe the Operational Qualification of Aluminium Strip Defoiler 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 will be operationally qualified in accordance with current Good Manufacturing Practices. SCOPE The …

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 …

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 …

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 …

FACILITY VALIDATION PROTOCOL TABLE OF CONTENTS SR. NO. CONTENTS PAGE NO. 1.0 APPROVAL   2.0 OBJECTIVE   3.0 SCOPE   4.0 RESPONSIBILITY   5.0   PROCEDURE   6.0 ACCEPTANCE CRITERIA   7.0 REQUALIFICATION CRITERIA   8.0 ABBREVIATIONS   9.0 REFERENCE   1.0 APPROVAL  The FACILITY VALIDATION PROTOCOL for Production Granulation area …

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 …

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 …

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 …

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 …