quality assurance and process control, documentation and validation

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Principles in Production Management

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PRODUCTION MANAGEMENT & DOCUMENTATION Presented by RAJA SUNNY. J I, M. Pharm. Presented to RAJASHEKAR. VALLURU PROFESSOR DEPT OF PHARMACEUTICS EAST WEST COLLEGE OF PHARMACY

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CONTENTS QUALITY ASSURANCE AND PROCESS CONTROL DOCUMENTATION VALIDATION

Quality The totality of features and characteristics of a product that bear on its ability to satisfy the stated or implied needs. :

Quality The totality of features and characteristics of a product that bear on its ability to satisfy the stated or implied needs.

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Introduction to Quality Assurance Every organization can improve the processes it utilizes to provide products and services. Such improvement will result in more satisfied customers lower operating costs faster product delivery, etc.

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Functions of Quality Assurance Department Issue of Batch Production Records Review of Batch Production Records Review of Quality Control Reports Issue of Product Release Certificates Shop floor Inspection Upkeep of Reference Samples Validations Preparation and Review of SOP’s Self Inspections

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Complaint Handling and Investigation Audit Preparations Vendor Audits Audit of Contract Manufacturing Units Trend Charts Salvaging Training and Development Documentation Check Samples Post production stability studies Product recall

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R ole of Quality Assurance D esign and monitoring of documentation systems Approval and monitoring of written procedures to produce the product A pproval of written records of the processing operations A pproval and monitoring of cleaning systems R egulatory control B atch or lot review Release of product.

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Issue of Batch Production Records The QA department issues the BPR’s when the batch is planned by production. The batch number will be coded on each and every page of the BPR. The signature of the QA person issueing the BPR and the date of issue of the BPR will be written on the last page of the BPR.

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THANK YOU…

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