DQ FOR PURE STEAM DISTRIBUTION SYSTEM (PSDS) Pure Steam is a critical utility used in pharmaceutical and biotechnology industries for sterilization and sanitization processes. It is generated from purified water or Water for Injection (WFI) and is free from contaminants such as pyrogens, chemicals, and microorganisms. Pure Steam is primarily used where direct contact with product-contact … Read more
DESIGN QUALIFICATION (DQ) FOR NITROGEN GAS DISTRIBUTION SYSTEM (NGDS) 1.0 INTRODUCTION : The Nitrogen Gas Distribution System (NGDS) is designed to supply nitrogen gas from the source/header line to various user points within the facility Design Qualification (DQ) ensures that the system design complies with: User Requirement Specifications (URS) Applicable cGMP guidelines Industry standards for pharmaceutical utilities … Read more
DESIGN QUALIFICATION (DQ) OF PURIFIED WATER GENERATION SYSTEM 1.0 INTRODUCTION : Design Qualification (DQ) is a documented verification that the proposed design of the Purified Water Generation System complies with the User Requirement Specification (URS), cGMP guidelines, and applicable regulatory standards. This document demonstrates that the system designed ,suitable for producing purified water meeting pharmacopoeial standards … Read more
SOP on Handling of Hazardous Chemicals 1.0 OBJECTIVE To lay down a systematic procedure for the safe handling, storage, and usage of hazardous chemicals to ensure personnel safety and compliance with regulatory requirements. 2.0 SCOPE This SOP is applicable to all personnel involved in handling hazardous chemicals. 3.0 RESPONSIBILITY 3.1 Officer and above shall be … Read more
SOP on Good Laboratory Practices (GLP) PROCEDURE Principles and Objectives of Good Laboratory Practices Ensure consistent quality through well-defined procedures and accurate record keeping.Maintain integrity by recording all results exactly as observed without manipulation.Ensure accuracy in all analytical activities to minimize errors and avoid rework.Demonstrate diligence by combining care, accuracy, and honesty in all laboratory … Read more
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INSTALLATION QUALIFICATION PROTOCOL DISPENSING BOOTH The Dispensing Booth is a reverse laminar airflow unit designed for safe and controlled handling of powders during dispensing operations. The system operates on the principle of negative pressure containment, ensuring that airborne particles generated during dispensing are effectively confined within the working area. The booth functions by drawing approximately 20% … Read more
INSTALLATION QUALIFICATION (IQ) PROTOCOL BLISTER PACKING MACHINE (ALU–ALU) The Blister Packing Machine (Alu–Alu) is a high-speed, continuous motion packaging system designed for packing tablets and hard gelatin capsules. The machine operates on flat forming and sealing principles using compressed air and hydraulic pressure, ensuring precision, consistency, and high productivity. It is equipped with an automatic feeding … Read more
SOP For Environmental Monitoring Frequency for Microbiological Areas 1.0 OBJECTIVE To establish a scientifically justified and GMP-compliant procedure for defining the frequency of environmental monitoring in microbiological controlled areas to ensure maintenance of cleanroom standards and microbial control. 2.0 SCOPE This SOP is applicable to all classified areas (Grade A, B, C, D) in: Microbiology … Read more
SOP For Washing, Preparation, and Sterilization of Sterile Garments 1.0 Objective 1.1 To establish a procedure for the washing, preparation, sterilization, inspection, and handling of sterile garments to ensure their suitability for use in sterile areas. 2.0 Scope 2.1 This SOP is applicable to all sterile garments used in the Production Department, including their washing, … Read more