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Validation & Qualification

Qualification & Validation of Equipment, Systems, Utilities in Pharmaceuticals

Qualification & Validation of Equipment Equipment qualification as required by the FDA requires verification documentation to start with the Validation Master Plan (VMP) and flow through a series of documents that define the scope and tasks required to successfully execute your equipment qualification task. The VMP dictates the actions that all persons involved …

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PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM

PERFORMANCE QUALIFICATION PROTOCOL PURIFIED WATER SYSTEM OBJECTIVE To describe the Performance Qualification procedure to be used during validation of purified water system in order to: a) ensure the system reproducibility over an appropriate time period as per user requirement specifications. b) ensure that the system is showing consistency in producing …

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Guidance Document Cleaning Validation

Guidance Document Cleaning Validation Scope Introduction Principles Validation of Cleaning Processes Equipment and Personnel Microbiological Considerations Documentation Analytical Methods Sampling, Rinsing, Rinse Samples and Detergents Establishment of Limits Change Control/revalidation References   3.1 The objective of the cleaning validation is to verify the effectiveness of the cleaning procedure for removal …

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GUIDE TO INSPECTIONS VALIDATION OF CLEANING PROCESSES

INTRODUCTION To establish inspection consistency and uniformity by discussing practices that has been found acceptable (or unacceptable). The cleaning validation – to validate the process and collect the scientific data that prove the system consistently does as expected and produce a result that consistently meets predetermined specifications. This guide is …

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Non-sterile process validation

Non-sterile process validation Process validation data should be generated for all products to demonstrate the adequacy of the manufacturing process at each site of manufacture. The validation should be carried out in accordance with good manufacturing practices (GMP) and data should be held at the manufacturing location and made available …

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URS of De-Dusting Machine

URS of De-Dusting Machine S. No. Table of Contents 1.0 General 2.0 Salient Features 3.0 Operational Requirements 4.0 Utilities 5.0 Maintenance 6.0 Commissioning and Documentation 7.0 Training 8.0 Packaging 9.0 Deviations 10.0 Delivery TECHNICAL  S. No. Parameters Required Specifications 1. 1.1 General Equipment No. 1.2 Description Portable unit for Tablets …

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Design Qualification of Gelatin Storage Vessel

Design Qualification of Gelatin Storage Vessel OBJECTIVE: To design, engineer and supply the 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 tolerances prescribed there in …

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Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical …

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Performace Qualification Protocol of Dispensing Booth

Pharmaceutical GuidanaceMr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco …

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QUALITY RISK MANAGEMENT (RISK ASSESSMENT)

1.0 Objective: To provide a procedure for carrying out Risk assessment, evaluation, mitigation and review of risk by employing appropriate tool of Quality Risk Management Process. 2.0 Scope: Applicable to different aspects of pharmaceutical quality like development, manufacturing, testing, distribution, inspection and submission/review processes throughout the life cycle of drug …

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