publication_title print_identifier online_identifier date_first_issue_online num_first_vol_online num_first_issue_online date_last_issue_online num_last_vol_online num_last_issue_online title_url first_author title_id embargo_info coverage_depth notes publisher_name publication_type date_monograph_published_print date_monograph_published_online monograph_volume monograph_edition first_editor parent_publication_title_id preceding_publication_title_id access_type 2023 ISPE Drug Shortages Prevention Model 9781946964649 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964649 10.1002/9781946964649 fulltext ISPE Monograph 5/1/2023 8/25/2023 1 initiatives P 503B Compounding – Regulatory Basis and Industry Good Practices for Outsourcing Facilities 9781946964694 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964694 10.1002/9781946964694 fulltext ISPE Monograph 8/16/2023 8/24/2023 1 ispeguide P Comprehensive Guide to Clinical Materials (A Handbook for Training Clinical Materials Professionals) 9781936379552 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379552 10.1002/9781936379552 fulltext ISPE Monograph 5/16/2012 5/16/2012 1 ippubs P ISPE Advancing Pharmaceutical Quality Guide: Change Management System 9781946964526 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964526 10.1002/9781946964526 fulltext ISPE Monograph 2/25/2022 3/14/2023 1 apq P ISPE Advancing Pharmaceutical Quality Guide: Corrective Action and Preventive Action (CAPA) System 9781946964366 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964366 10.1002/9781946964366 fulltext ISPE Monograph 11/30/2020 3/20/2023 1 apq P ISPE Advancing Pharmaceutical Quality Guide: Cultural Excellence 9781946964595 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964595 10.1002/9781946964595 fulltext ISPE Monograph 11/17/2022 2/26/2023 apq P ISPE Advancing Pharmaceutical Quality Guide: Management Responsibilities and Management Review 9781946964441 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964441 10.1002/9781946964441 fulltext ISPE Monograph 7/23/2021 3/20/2023 1 apq P ISPE Advancing Pharmaceutical Quality Guide: Process Performance and Product Quality Monitoring System 9781946964588 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964588 10.1002/9781946964588 fulltext ISPE Monograph 9/22/2022 3/14/2023 apq P ISPE Baseline® Guide: Volume 1 – Active Pharmaceutical Ingredients (Revision to Bulk Pharmaceutical Chemicals) (Second Edition) 9781931879781 https://guidance-docs.ispe.org/doi/book/10.1002/9781931879781 10.1002/9781931879781 fulltext ISPE Monograph 6/24/2007 3/20/2023 2 baseline P ISPE Baseline® Guide: Volume 2 – Oral Solid Dosage Forms (Third Edition) 9781936379880 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379880 10.1002/9781936379880 fulltext ISPE Monograph 11/18/2016 3/20/2023 3 baseline P ISPE Baseline® Guide: Volume 3 – Sterile Product Manufacturing Facilities (Third Edition) 9781946964069 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964069 10.1002/9781946964069 fulltext ISPE Monograph 4/12/2018 3/20/2023 3 baseline P ISPE Baseline® Guide: Volume 3 – Sterile Product Manufacturing Facilities (Third Edition) [Japanese Translation] 9781946964434 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964434 10.1002/9781946964434 fulltext ISPE Monograph 11/11/2022 5/26/2023 3 baseline P ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Third Edition) 9781946964250 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964250 10.1002/9781946964250 fulltext ISPE Monograph 9/30/2019 3/20/2023 3 baseline P ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition) 9781946964236 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964236 10.1002/9781946964236 fulltext ISPE Monograph 6/28/2019 3/20/2023 2 baseline P ISPE Baseline® Guide: Volume 5 – Commissioning and Qualification (Second Edition) [Japanese Translation] 9781946964328 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964328 10.1002/9781946964328 fulltext ISPE Monograph 7/30/2021 5/26/2023 2 baseline P ISPE Baseline® Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities (Third Edition) 9781946964717 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964717 10.1002/9781946964717 fulltext ISPE Monograph 11/17/2023 11/16/2023 3 baseline P ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition) 9781936379941 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379941 10.1002/9781936379941 fulltext ISPE Monograph 7/17/2017 3/20/2023 2 baseline P ISPE Baseline® Guide: Volume 7 – Risk-Based Manufacture of Pharmaceutical Products (Second Edition) [Russian Translation] 9781946964397 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964397 10.1002/9781946964397 fulltext ISPE Monograph 3/12/2021 5/26/2023 2 baseline P ISPE Baseline® Guide: Volume 8 – Pharma 4.0™ 9781946964724 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964724 10.1002/9781946964724 fulltext ISPE Monograph 12/18/2023 12/17/2023 1 baseline P ISPE D/A/CH Affiliate: Production of Water for Injection without Distillation Handbook [English Translation] 9781946964359 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964359 10.1002/9781946964359 fulltext ISPE Monograph 9/7/2021 5/17/2023 1 affiliate P ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) 9781946964571 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964571 10.1002/9781946964571 fulltext ISPE Monograph 7/1/2022 3/20/2023 2 gamp P ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems [Chinese Translation] 9781931879699 https://guidance-docs.ispe.org/doi/book/10.1002/9781931879699 10.1002/9781931879699 fulltext ISPE Monograph 7/7/2019 5/26/2023 1 gamp P ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems [French Translation] 9781936379378 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379378 10.1002/9781936379378 fulltext ISPE Monograph 1/27/2012 5/26/2023 1 gamp P ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems [German Translation] 9781936379361 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379361 10.1002/9781936379361 fulltext ISPE Monograph 1/27/2012 5/26/2023 1 gamp P ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems [Polish Translation] 9781946964212 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964212 10.1002/9781946964212 fulltext ISPE Monograph 7/15/2019 5/26/2023 1 gamp P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) 9781936379002 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379002 10.1002/9781936379002 fulltext ISPE Monograph 11/5/2010 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) 9781936379491 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379491 10.1002/9781936379491 fulltext ISPE Monograph 10/17/2012 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition) 9781936379057 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379057 10.1002/9781936379057 fulltext ISPE Monograph 2/10/2011 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems 9781931879736 https://guidance-docs.ispe.org/doi/book/10.1002/9781931879736 10.1002/9781931879736 fulltext ISPE Monograph 5/3/2010 3/20/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems [German Translation] 9781946964021 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964021 10.1002/9781946964021 fulltext ISPE Monograph 8/19/2013 5/26/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications 9781936379750 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379750 10.1002/9781936379750 fulltext ISPE Monograph 10/10/2014 3/14/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) 9781936379514 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379514 10.1002/9781936379514 fulltext ISPE Monograph 12/14/2012 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition) [German Translation] 9781936379613 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379613 10.1002/9781936379613 fulltext ISPE Monograph 7/15/2013 5/26/2023 2 gampgpg P "ISPE GAMP® Good Practice Guide: Enabling Innovation – Critical Thinking, Agile, IT Service Management" 9781946964465 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964465 10.1002/9781946964465 fulltext ISPE Monograph 9/1/2021 3/20/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition) 9781936379927 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379927 10.1002/9781936379927 fulltext ISPE Monograph 2/7/2017 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) 9781946964007 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964007 10.1002/9781946964007 fulltext ISPE Monograph 8/29/2017 3/20/2023 2 gampgpg P ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach 9781931879934 https://guidance-docs.ispe.org/doi/book/10.1002/9781931879934 10.1002/9781931879934 fulltext ISPE Monograph 5/3/2010 3/20/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: Manufacturing Execution Systems – A Strategic and Program Management Approach [Chinese Translation] 9781936379798 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379798 10.1002/9781936379798 fulltext ISPE Monograph 2/1/2014 5/26/2023 1 gampgpg P ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition) 9781946964786 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964786 10.1002/9781946964786 fulltext ISPE Monograph 7/31/2024 7/30/2024 2 gampgpg P ISPE GAMP® Guide: Records and Data Integrity 9781936379965 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379965 10.1002/9781936379965 fulltext ISPE Monograph 3/31/2017 3/20/2023 1 gamp P ISPE GAMP® Guide: Records and Data Integrity [German Translation] 9781946964045 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964045 10.1002/9781946964045 fulltext ISPE Monograph 1/8/2018 5/26/2023 1 gamp P ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design 9781946964342 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964342 10.1002/9781946964342 fulltext ISPE Monograph 10/1/2020 3/20/2023 1 gampgpg P ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts 9781946964113 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964113 10.1002/9781946964113 fulltext ISPE Monograph 10/12/2018 3/20/2023 1 gampgpg P ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts [Japanese Translation] 9781946964656 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964656 10.1002/9781946964656 fulltext ISPE Monograph 3/21/2024 3/21/2024 1 gampgpg P ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records 9781946964205 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964205 10.1002/9781946964205 fulltext ISPE Monograph 5/23/2019 3/20/2023 1 gampgpg P ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition) 9781936379736 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379736 10.1002/9781936379736 fulltext ISPE Monograph 7/22/2014 7/22/2014 2 ispegpg P ISPE Good Practice Guide: Asset Management 9781946964267 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964267 10.1002/9781946964267 fulltext ISPE Monograph 11/29/2019 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Booklet Labels 9781936379583 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379583 10.1002/9781936379583 fulltext ISPE Monograph 3/8/2013 3/14/2023 ispegpg P ISPE Good Practice Guide: Clinical Supply Systems 9781936379682 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379682 10.1002/9781936379682 fulltext ISPE Monograph 3/31/2014 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Cold Chain Management 9781936379071 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379071 10.1002/9781936379071 fulltext ISPE Monograph 5/5/2011 5/5/2011 1 ispegpg P ISPE Good Practice Guide: Comparator Management 9781936379330 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379330 10.1002/9781936379330 fulltext ISPE Monograph 2/24/2012 3/14/2023 1 ispegpg P ISPE Good Practice Guide: Containment for Potent Compounds 9781946964601 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964601 10.1002/9781946964601 fulltext ISPE Monograph 12/19/2022 12/19/2022 1 ispegpg P ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms 9781946964540 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964540 10.1002/9781946964540 fulltext ISPE Monograph 3/31/2022 3/31/2022 1 ispegpg P "ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition)" 9781946964519 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964519 10.1002/9781946964519 fulltext ISPE Monograph 12/14/2021 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It 9781946964298 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964298 10.1002/9781946964298 fulltext ISPE Monograph 6/30/2020 3/14/2023 1 ispegpg P ISPE Good Practice Guide: Decommissioning of Pharmaceutical Equipment and Facilities 9781936379996 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379996 10.1002/9781936379996 fulltext ISPE Monograph 6/15/2017 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products 9781931879910 https://guidance-docs.ispe.org/doi/book/10.1002/9781931879910 10.1002/9781931879910 fulltext ISPE Monograph 3/30/2010 3/14/2023 1 ispegpg P ISPE Good Practice Guide: Equipment Reliability 9781946964373 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964373 10.1002/9781946964373 fulltext ISPE Monograph 12/21/2020 12/21/2020 1 ispegpg P ISPE Good Practice Guide: Good Engineering Practice (Second Edition) 9781946964489 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964489 10.1002/9781946964489 fulltext ISPE Monograph 10/28/2021 10/28/2021 2 ispegpg P ISPE Good Practice Guide: HVAC and Process Equipment Air Filters 9781946964274 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964274 10.1002/9781946964274 fulltext ISPE Monograph 12/19/2019 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products 9781936379576 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379576 10.1002/9781936379576 fulltext ISPE Monograph 1/31/2013 3/14/2023 1 ispegpg P "ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (Second Edition)" 9781946964793 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964793 10.1002/9781946964793 fulltext ISPE Monograph 9/25/2024 9/30/2024 2 ispegpg P ISPE Good Practice Guide: Interactive Response Technology 9781936379279 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379279 10.1002/9781936379279 fulltext ISPE Monograph 11/4/2011 3/14/2023 1 ispegpg P ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices 9781946964458 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964458 10.1002/9781946964458 fulltext ISPE Monograph 8/27/2021 3/14/2023 1 ispegpg P ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry 9781946964427 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964427 10.1002/9781946964427 fulltext ISPE Monograph 5/10/2021 5/10/2021 1 ispegpg P ISPE Good Practice Guide: Maintenance (Second Edition) 9781946964380 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964380 10.1002/9781946964380 fulltext ISPE Monograph 1/28/2021 1/28/2021 2 ispegpg P ISPE Good Practice Guide: Management of Engineering Standards 9781936379859 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379859 10.1002/9781936379859 fulltext ISPE Monograph 8/29/2016 3/14/2023 ispegpg P ISPE Good Practice Guide: Membrane-Based Water for Injection Systems 9781946964564 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964564 10.1002/9781946964564 fulltext ISPE Monograph 5/25/2022 5/25/2022 1 ispegpg P ISPE Good Practice Guide: Operations Management 9781936379835 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379835 10.1002/9781936379835 fulltext ISPE Monograph 4/22/2016 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems (Second Edition) 9781946964809 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964809 10.1002/9781946964809 fulltext ISPE Monograph 10/25/2024 10/24/2024 2 ispegpg P "ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities" 9781936379415 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379415 10.1002/9781936379415 fulltext ISPE Monograph 6/11/2012 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation 9781946964182 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964182 10.1002/9781946964182 fulltext ISPE Monograph 3/1/2019 5/17/2023 1 ispegpg P ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation [Chinese Translation] 9781946964663 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964663 10.1002/9781946964663 fulltext ISPE Monograph 5/1/2023 8/24/2023 1 ispegpg P ISPE Good Practice Guide: Process Gases (Second Edition) 9781946964700 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964700 10.1002/9781946964700 fulltext ISPE Monograph 10/6/2023 10/6/2023 2 ispegpg P ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry 9781936379255 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379255 10.1002/9781936379255 fulltext ISPE Monograph 11/3/2011 11/3/2011 1 ispegpg P ISPE Good Practice Guide: Quality Laboratory Facilities 9781936379439 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379439 10.1002/9781936379439 fulltext ISPE Monograph 9/12/2012 9/12/2012 1 ispegpg P ISPE Good Practice Guide: SMEPAC – Standardized Methodology for the Evaluation of Pharmaceutical Airborne Particle Emissions from Containment Systems (Third Edition) 9781946964816 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964816 10.1002/9781946964816 fulltext ISPE Monograph 12/5/2024 12/5/2024 3 ispegpg P "ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases" 9781936379897 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379897 10.1002/9781936379897 fulltext ISPE Monograph 12/20/2016 3/20/2023 1 ispegpg P ISPE Good Practice Guide: Single-Use Technology 9781946964137 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964137 10.1002/9781946964137 fulltext ISPE Monograph 11/2/2018 5/17/2023 1 ispegpg P ISPE Good Practice Guide: Technology Transfer (Third Edition) 9781946964151 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964151 10.1002/9781946964151 fulltext ISPE Monograph 12/20/2018 3/20/2023 3 ispegpg P ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations 9781946964762 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964762 10.1002/9781946964762 fulltext ISPE Monograph 5/28/2024 5/28/2024 1 ispegpg P ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 1 – Product Realization using Quality by Design (QbD): Concepts and Principles 9781936379224 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379224 10.1002/9781936379224 fulltext ISPE Monograph 11/2/2011 11/2/2011 1 pqli P ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 2 – Product Realization using Quality by Design (QbD): Illustrative Example 9781936379231 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379231 10.1002/9781936379231 fulltext ISPE Monograph 11/2/2011 11/2/2011 1 pqli P ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System 9781936379460 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379460 10.1002/9781936379460 fulltext ISPE Monograph 6/1/2012 3/14/2023 1 pqli P ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 4 – Process Performance and Product Quality Monitoring System (PP&PQMS) 9781936379606 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379606 10.1002/9781936379606 fulltext ISPE Monograph 6/10/2013 3/14/2023 1 pqli P ISPE Guide: 503A Compounding – Regulatory Basis and Industry Good Practices for Pharmacies 9781946964755 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964755 10.1002/9781946964755 fulltext ISPE Monograph 4/16/2024 4/15/2024 1 ispeguide P ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy 9781946964748 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964748 10.1002/9781946964748 fulltext ISPE Monograph 1/8/2024 1/7/2024 1 ispeguide P ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy 9781946964502 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964502 10.1002/9781946964502 fulltext ISPE Monograph 11/1/2021 3/20/2023 1 ispeguide P ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecycle Management 9781946964731 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964731 10.1002/9781946964731 fulltext ISPE Monograph 1/8/2024 1/7/2024 1 ispeguide P ISPE Guide: Biopharmaceutical Process Development and Manufacturing 9781936379637 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379637 10.1002/9781936379637 fulltext ISPE Monograph 10/28/2013 3/20/2023 1 ispeguide P "ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls" 9781946964311 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964311 10.1002/9781946964311 fulltext ISPE Monograph 8/31/2020 3/20/2023 1 ispeguide P ISPE Handbook: Sustainability 9781936379828 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379828 10.1002/9781936379828 fulltext ISPE Monograph 12/21/2015 12/21/2015 1 handbook P ISPE Japan Affiliate: Pest Control Manual [English Translation] 9781946964083 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964083 10.1002/9781946964083 fulltext ISPE Monograph 8/30/2018 5/17/2023 1 affiliate P ISPE Readiness Report Bundle 9781946964687 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964687 10.1002/9781946964687 fulltext ISPE Monograph 5/1/2023 8/25/2023 1 initiatives P Introductory US Clinical Trial Materials Training Guide 9781936379781 https://guidance-docs.ispe.org/doi/book/10.1002/9781936379781 10.1002/9781936379781 fulltext ISPE Monograph 10/1/2002 8/2/2023 2 ippubs P The Cultural Excellence Report - Six Key Dimensions 9781946964618 https://guidance-docs.ispe.org/doi/book/10.1002/9781946964618 10.1002/9781946964618 fulltext ISPE Monograph 4/25/2017 6/13/2023 1 initiatives P