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Equipment Qualification

Equipment Qualification Contents Validation User Requirement Specification.(URS) Phase of validation Design qualification (DQ) Installation Qualification (IQ) Operation Qualification (OQ) Performance Qualification (PQ) Maintenance Qualification (MQ) Component Qualification (CQ) Instrument Re-Qualification What is Validation According to the Food and Drug Administration (FDA), the goal of validation is to: “Establish documented evidence …

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GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS

GUIDE TO INSPECTIONS OF HIGH PURITY WATER SYSTEMS I. SYSTEM DESIGN For parenteral products where there is a concern for pyrogens, it is expected that Water for Injection will be used, This applies to the formulation of products, as well as to the final washing of components and equipment used …

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Engineering Documentation in Pharmaceutical Industry

Engineering Documentation in Pharmaceutical Industry Heat Load Calculations. AHU Zoning drawing with pressure differentials. Airflow diagram. Ducting layout. Piping Layout. Hepa Box G.A. Man Movements layout Material Movements layout The layout of Pressure difference and area classification in production Area Qualification Area Mapping Commissioning Report of HVAC System Airflow & …

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Environmental Monitoring

Environmental Monitoring – All environmental parameters listed under para 3.1 to 3.10 shall be verified and established at the time of installation and thereafter monitored at periodic intervals. The recommended frequencies of periodic monitoring shall be as follows: ( a ) Particulate monitoring in air – 6 Monthly (b) HEPA …

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List OF SOPs ENGINEERING

List OF SOPs ENGINEERING S. No. SOP Title 1. Preventive Maintenance 2. Breakdown Maintenance Procedure of the Equipment and Machines 3. Colour Coding of Utility Lines 4. Procedure for Building Maintenance 5. Calibration of Equipment and Instrument from External Authorized Body / Suppliers 6. Operating procedure of Vacuum Circuit Breakers …

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Principles of HVAC Duct Design in Pharma Industry

Principles of HVAC Duct Design in Pharma Industry How Does a Duct System Work  The duct, or air distribution, system used in cooling and heating your area is a collection of tubes that distributes the heated or cooled air to the different rooms in Pharma Industry. This branching network of …

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PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT

PREVENTIVE MAINTENANCE OF PRODUCTION EQUIPMENT OBJECTIVE; To define the procedure for preventive maintenance of production equipment. SCOPE: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: This procedure is applicable for preventive maintenance of production equipment. RESPONSIBILITY: Mechanical Engineer ACCOUNTABILITY: Engineer Head ATTACHMENTS: Attachment I – Preventive maintenance …

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All Post URL of Drugs formulations

All Post URL of Drugs formulations Tablets MFR of Albendazole Tablets – (drugsformulations.com) MFR of Alfacalcidol & Calcium Carbonate Tablets (drugsformulations.com) MFR of Sildenafil Citrate Tablets (drugsformulations.com) MFR of Paracetamol & Dicyclomine HCl Tablets – (drugsformulations.com) MFR of Dextromethorphan, Bromhexine, Chlorpheniramine Maleate & Guaifenesin  Tablets (drugsformulations.com) Dextromethorphan (drugsformulations.com) Spiramycin Tablet (drugsformulations.com) MFR of Propranolol Hydrochloride …

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DESIGN QUALIFICATION FOR PURIFIED WATER STORAGE & DISTRIBUTION SYSTEM

TABLE OF CONTENTS 1.0       DESIGN QUALIFICATION PROTOCOL APPROVAL 2.0       INTRODUCTION 3.0       OBJECTIVE: 4.0       SCOPE 5.0       RESPONSIBILITY 6.0       BASIS OF DESIGN 7.0       SYSTEM DESCRIPTION 8.0     SCOPE OF SUPPLY AND TECHNICAL SPECIFICATIONS 9.0       PANEL INTERLOCKS AND OPERATIONAL LOGICS 10.0    CRITICAL SAFETY REQUIREMENTS 11.0    SAMPLING PLAN 12.0    SANITISATION CYCLE 14.0    LIST OF APPROVED …

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SOP on Operation of Effluent Treatment Plant

Objective: To lay down the procedure for operation of Effluent Treatment Plant. Scope: This SOP is applicable for engineering department for operation of effluent treatment plant at formulation plant. Responsibility: Technician/above –Engineering. Department is responsible for operation of ETP Plant. Accountability: Head- Engineering. Shall be accountable for implementation and compliance …

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