Yearly Archives: 2017

Operational Qualification of Aluminium Strip Defoiler

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 …

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Dust control during AHU design in Pharma Company

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 …

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SOP For QUALITY BY DESIGN (QBD) IN PHAARMACEUTICAL PRODUCT

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 …

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FACILITY VALIDATION PROTOCOL

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 …

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SOP Operational Qualification of Raw Gelatin Storage Vessel

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 …

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SOP For Installation Qualification of Encapsulation Machine

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 …

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Facility Validation in pharmaceutical Pharma Company

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 …

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