Overview

This handbook is fully updated to the current regulatory requirement in the pharmaceutical laboratory world. Purpose of book is to assist individual on Gx Prequirement, good manufacturing practices, good laboratory practices, performance monitoring and root cause analysis and quality triangles The purpose of this hand book is to provide easily accessible knowledge about the good laboratory practices. In current pharmaceutical world we need a fast and reliable source of techniques to implement the system and resolve problem. This handbook gives pathway for us to take right decision. Nothing comes in one box for us. Changes happen with or without us. The higher we go in the organization, the more complex ore challenges become .This book gives overall view of quality laboratory system. We hope this handbook can contributes to assemble lots of related materials and package them in one place for easy reference and access. I encourage you to read, enjoy, study and learn from this book and go forth and empower you/ your teams to lead you and your organization to world class results.

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9789389974263

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Trupti Patil-Dongare has over 16 years of experience in pharmaceutical industry. Trupti has completed Doctor of Philosophy in Pharmacy, Master's in industrial pharmacy, Advance Diploma in Quality Assurance and IRCA approved ISO 9001:2015 Lead Auditor. Versatile knowledge on all key pharmaceutical function, provides technical and regulatory consulting to the pharmaceutical industry for the manufacturers of dosage forms, bulk drugs and clinical research labs. The areas of technical and consulting include validation, regulatory submissions, quality systems, facility audits, product specifications, process upgrades, product development, BA/BE clinical research and batch certification for clients. Facility design, infrastructure development and improvement for manufacturing plants for APIs, oral solids, topicals, injectables and ophthalmics for regular, oncologic and beta lactam type products in US, Europe and India with respective to quality and regulatory compliance.

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