ISPE

International Society for Pharmaceutical Engineering

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ISPE ★★★★★

ISPE Guide - Advanced Therapy Medicinal Products - Recombinant AAV Comparability and Lifecycle Management 2023

Publication date: 2023-12-01 Points: 390 File size: 3.63 MB Pages: 98 Format: PDF

ISPE ★★★★★

ISPE Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 2021

Publication date: 2021-12-01 ISBN: 978-1-946-96450-2 Points: 390 File size: 7.99 MB Pages: 148 Format: PDF

ISPE ★★★★★

ISPE Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 2023 Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities

Publication date: 2023-12-01 ISBN: 978-1-946-96469-4 Points: 390 File size: 1.73 MB Pages: 122 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Technology Transfer 2018

Publication date: 2018-12-01 ISBN: 978-1-946-96415-1 Points: 390 File size: 3.31 MB Pages: 152 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Single-Use Technology 2018

Publication date: 2018-12-01 ISBN: 978-1-946-96413-7 Points: 390 File size: 8.91 MB Pages: 180 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Sampling for Pharmaceutical Water, Steam, and Process Gases 2016

Publication date: 2016-12-01 ISBN: 978-1-936-37989-7 Points: 390 File size: 2.97 MB Pages: 122 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Quality Laboratory Facilities 2012

Publication date: 2012-12-01 ISBN: 978-1-936-37943-9 Points: 390 File size: 5.89 MB Pages: 176 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Project Management for the Pharmaceutical Industry 2011

Publication date: 2011-12-01 ISBN: 978-1-936-37925-5 Points: 390 File size: 8.96 MB Pages: 282 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Process Gases 2023

Publication date: 2023-12-01 ISBN: 978-1-946-96470-0 Points: 390 File size: 6.16 MB Pages: 152 Format: PDF

ISPE ★★★★★

ISPE Good Practice Guide - Practical Implementation of the Lifecycle Approach to Process Validation 2019

Publication date: 2019-12-01 ISBN: 978-1-946-96418-2 Points: 390 File size: 16.54 MB Pages: 208 Format: PDF

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Hot Products

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ISPE Good Practice Guide - Critical Utilities GMP Compliance 2020

Good Practice Guide - Critical Utilities GMP Compliance

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ISPE Baseline Guide - Pharma 4.0 2023

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ISPE Good Practice Guide - Project Management for the Pharmaceutical Industry 2011

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ISPE Guide Series PQLI Part 2 - Product Realization using Quality by Design (QbD) - Illustrative Example 2011

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ISPE Good Practice Guide - Decommissioning of Pharmaceutical Equipment and Facilities 2017

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ISPE Baseline Guide volume 4 - Water and Steam Systems 2019

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ISPE Guide - Biopharmaceutical Process Development and Manufacturing 2013

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ISPE GAMP Good Practice Guide - A Risk-Based Approach to Testing of GxP Systems 2012

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ISPE GAMP Good Practice Guide - A Risk-Based Approach to Operation of GxP Computerized Systems 2009

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ISPE Baseline Guide volume 2 - Oral Solid Dosage Forms 2016

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ISPE GAMP RDI Good Practice Guide - Data Integrity - Key Concepts 2018

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ISPE APQ Guide - Management responsibilities and management review 2021

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ISPE Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 2021

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ISPE Guide - Cleaning Validation Lifecycle - Applications, Methods, and Controls 2020

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ISPE Good Practice Guide - Quality Laboratory Facilities 2012

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ISPE Good Practice Guide - Development of Investigational Therapeutic Biological Products 2007

Good Practice Guide - Development of Investigational Therapeutic Biological Products

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ISPE

ISPE Guide - Advanced Therapy Medicinal Products - Recombinant AAV Comparability and Lifecycle Management 2023

ISPE Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 2021

ISPE Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 2023

ISPE Good Practice Guide - Technology Transfer 2018

ISPE Good Practice Guide - Single-Use Technology 2018

ISPE Good Practice Guide - Sampling for Pharmaceutical Water, Steam, and Process Gases 2016

ISPE Good Practice Guide - Quality Laboratory Facilities 2012

ISPE Good Practice Guide - Project Management for the Pharmaceutical Industry 2011

ISPE Good Practice Guide - Process Gases 2023

ISPE Good Practice Guide - Practical Implementation of the Lifecycle Approach to Process Validation 2019

Hot Products

ISPE Good Practice Guide - Process Gases 2023

ISPE Good Practice Guide - Good Engineering Practice 2021

ISPE Good Practice Guide - Equipment Reliability 2020

ISPE Good Practice Guide - Critical Utilities GMP Compliance 2020

ISPE Baseline Guide - Pharma 4.0 2023

ISPE Good Practice Guide - Project Management for the Pharmaceutical Industry 2011

ISPE Guide Series PQLI Part 2 - Product Realization using Quality by Design (QbD) - Illustrative Example 2011

ISPE Good Practice Guide - Decommissioning of Pharmaceutical Equipment and Facilities 2017

ISPE Baseline Guide volume 4 - Water and Steam Systems 2019

ISPE Guide - Biopharmaceutical Process Development and Manufacturing 2013

ISPE GAMP Good Practice Guide - A Risk-Based Approach to Testing of GxP Systems 2012

ISPE GAMP Good Practice Guide - A Risk-Based Approach to Operation of GxP Computerized Systems 2009

ISPE Baseline Guide volume 2 - Oral Solid Dosage Forms 2016

ISPE GAMP RDI Good Practice Guide - Data Integrity - Key Concepts 2018

ISPE APQ Guide - Management responsibilities and management review 2021

ISPE Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 2021

ISPE Guide - Cleaning Validation Lifecycle - Applications, Methods, and Controls 2020

ISPE Good Practice Guide - Quality Laboratory Facilities 2012

ISPE Good Practice Guide - Development of Investigational Therapeutic Biological Products 2007

ISPE Guide Series PQLI Part 1 - Product Realization using Quality by Design (QbD) - Concepts and Principles 2011