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Validation & Qualification

HVAC systems for non-sterile pharmaceutical as per WHO TRS. 937, 2006 ,Annex 2

WHO Technical Report Series, No. 937, 2006 ,Annex 2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 1. Introduction 2. Scope of document 3. Protection 3.1 Products and personnel 3.2 Air filtration 3.3 Unidirectional airflow 3.4 Infiltration 3.5 Cross-contamination 3.6 Temperature …

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Temperature mapping of storage areas – TRS 961, Annex 9

Temperature mapping of storage areas (WHO Technical Report Series, No. 961, 2011, Annex 9) The purpose of a temperature mapping study is to document and control the temperature distribution within a storage area. Temperature mapping of storage areas is a systematic mapping procedure in any cold room, freezer room, or …

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VIAL WASHING MACHINE PQ PROTOCOL

VIAL WASHING MACHINE PQ PROTOCOL TABLE OF CONTENTS S. No. Description 1.0 Protocol approval 2.0 Overview 2.1 Purpose 2.2 Scope 2.3 Responsibilities and identification of execution team 3.0 Pre-Validation requirement 4.0 Equipment description 5.0 Validation procedure 6.0 Sampling plan and Acceptance criteria 7.0 Validation report 8.0 Validation approval 9.0 Observed …

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Design Qualification of Gelatin Colour Mixer

OBJECTIVE: To design, engineer and supply the Gelatin Colour Mixer 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 document, are the same at …

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Installation Qualification of Gelatin Storage Vessel

PURPOSE: To describe the Installation Qualification of Gelatin Storage Vessel 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 the system …

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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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Process Validation: General Principles (USFDA) in Pharma Industry

Process Validation: General Principles (USFDA) in Pharma Industry This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes. FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle. The lifecycle concept links …

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Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals

Establishment of a Control Procedure for Technical Equipment, including related Utilities, Computerized Systems and Facilities used in the Manufacture of Pharmaceuticals A formal change control system should be established to evaluate all changes that may affect production and control of the intermediate or API. There should be a written procedure …

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Qualification of existing facilities, systems, equipment and utilities

Qualification of existing facilities, systems, equipment, and utilities An existing facility has a mixture of new fully qualified equipment (DQ, IQ, OQ, PQ) and partially qualified/ unqualified equipment. Through many years of use, it can usually be shown that facilities, systems, equipment, and utilities can function to varied requirements. Nevertheless, …

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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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