24.07.2024




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List of ISPE in our library
(перечень имеющихся документов ISPE)

ISPE APQ Guide - Change Management System 2022
ISPE APQ Guide - Cultural Excellence 2022
ISPE APQ Guide - Management responsibilities and management review 2021
ISPE APQ Guide Series - Corrective Action and Preventive Action (CAPA) System 2020
ISPE APQ Guide Series - Process Performance and Product Quality Monitoring System 2022
ISPE Baseline Guide - Pharma 4.0 2023
ISPE Baseline Guide volume 1 - Active Pharmaceutical Ingredients 2007
ISPE Baseline Guide volume 2 - Oral Solid Dosage Forms 2016
ISPE Baseline Guide volume 3 - Sterile Product Manufacturing Facilities 2018
ISPE Baseline Guide volume 4 - Water and Steam Systems 2019
ISPE Baseline Guide volume 5 - Commissioning and Qualification 2019
ISPE Baseline Guide volume 6 - Biopharmaceutical Manufacturing Facilities 2023
ISPE Baseline Guide volume 7 - Risk-Based Manufacture of Pharmaceutical Products 2017
ISPE Comprehensive Guide to Clinical Materials 2006
ISPE Cultural Excellence Report 2017
ISPE Drug Shortages Prevention Model 2023
ISPE GAMP 5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems 2022
ISPE GAMP Good Practice Guide - A Risk-Based Approach to Calibration Management 2010
ISPE GAMP Good Practice Guide - A Risk-Based Approach to Compliant Electronic Records and Signatures 2005
ISPE GAMP Good Practice Guide - A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems 2012
ISPE GAMP Good Practice Guide - A Risk-Based Approach to GxP Process Control Systems 2011
ISPE GAMP Good Practice Guide - A Risk-Based Approach to Operation of GxP Computerized Systems 2009
ISPE GAMP Good Practice Guide - A Risk-Based Approach to Regulated Mobile Applications 2014
ISPE GAMP Good Practice Guide - A Risk-Based Approach to Testing of GxP Systems 2012
ISPE GAMP Good Practice Guide - Electronic Data Archiving 2007
ISPE GAMP Good Practice Guide - Enabling Innovation 2021
ISPE GAMP Good Practice Guide - Global Information Systems Control and Compliance 2017
ISPE GAMP Good Practice Guide - IT Infrastructure Control and Compliance 2017
ISPE GAMP Good Practice Guide - Manufacturing Execution Systems - A Strategic and Program Management Approach 2010
ISPE GAMP Good Practice Guide - Validation and Compliance of Computerized GCP Systems and Data 2017
ISPE GAMP Guide - Records and Data Integrity 2017
ISPE GAMP RDI Good Practice Guide - Data Integrity - Key Concepts 2018
ISPE GAMP RDI Good Practice Guide - Data Integrity - Manufacturing Records 2019
ISPE GAMP RDI Good Practice Guide - Data Integrity by Design 2020
ISPE Good Practice Guide - Applied Risk Management for Commissioning and Qualification 2011
ISPE Good Practice Guide - Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems 2014
ISPE Good Practice Guide - Assessing the particulate containment performance of pharmaceutical equipment 2012
ISPE Good Practice Guide - Asset Management 2019
ISPE Good Practice Guide - Booklet Labels 2013
ISPE Good Practice Guide - Clinical Supply Systems 2014
ISPE Good Practice Guide - Cold Chain Management 2011
ISPE Good Practice Guide - Comparator Management 2012
ISPE Good Practice Guide - Containment for Potent Compounds 2022
ISPE Good Practice Guide - Continuous Manufacturing of Oral Solid Dosage Forms 2022
ISPE Good Practice Guide - Controlled Temperature Chambers 2021
ISPE Good Practice Guide - Critical Utilities GMP Compliance 2020
ISPE Good Practice Guide - Decommissioning of Pharmaceutical Equipment and Facilities 2017
ISPE Good Practice Guide - Development of Investigational Therapeutic Biological Products 2007
ISPE Good Practice Guide - Equipment Reliability 2020
ISPE Good Practice Guide - Good Engineering Practice 2021
ISPE Good Practice Guide - Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) 2013
ISPE Good Practice Guide - Heating, Ventilation, and Air Conditioning 2009
ISPE Good Practice Guide - HVAC and Process Equipment Air Filters 2019
ISPE Good Practice Guide - Interactive Response Technology 2011
ISPE Good Practice Guide - Investigational Medicinal Product Reverse Logistics 2021
ISPE Good Practice Guide - Knowledge Management in the Pharmaceutical Industry 2021
ISPE Good Practice Guide - Maintenance 2021
ISPE Good Practice Guide - Management of Engineering Standards 2016
ISPE Good Practice Guide - Membrane-Based Water for Injection Systems 2022
ISPE Good Practice Guide - Operations Management 2016
ISPE Good Practice Guide - Ozone Sanitization of Pharmaceutical Water Systems 2012
ISPE Good Practice Guide - Packaging, Labeling, and Warehousing Facilities 2012
ISPE Good Practice Guide - Practical Implementation of the Lifecycle Approach to Process Validation 2019
ISPE Good Practice Guide - Process Gases 2011
ISPE Good Practice Guide - Process Gases 2023
ISPE Good Practice Guide - Project Management for the Pharmaceutical Industry 2011
ISPE Good Practice Guide - Quality Laboratory Facilities 2012
ISPE Good Practice Guide - Sampling for Pharmaceutical Water, Steam, and Process Gases 2016
ISPE Good Practice Guide - Single-Use Technology 2018
ISPE Good Practice Guide - Technology Transfer 2018
ISPE Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 2023
ISPE Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 2021
ISPE Guide - Advanced Therapy Medicinal Products - Recombinant AAV Comparability and Lifecycle Management 2023
ISPE Guide - Biopharmaceutical Process Development and Manufacturing 2013
ISPE Guide - Cleaning Validation Lifecycle - Applications, Methods, and Controls 2020
ISPE Guide - Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment 2011
ISPE Guide Series PQLI Part 1 - Product Realization using Quality by Design (QbD) - Concepts and Principles 2011
ISPE Guide Series PQLI Part 2 - Product Realization using Quality by Design (QbD) - Illustrative Example 2011
ISPE Guide Series PQLI Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System 2012
ISPE Guide Series PQLI Part 4 - Process Performance and Product Quality Monitoring System 2012
ISPE Handbook - Sustainability 2015
ISPE Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients 2020
ISPE Report on ISPE work to support establishment of the EU Health Emergency Preparedness and Response Authority (HERA) 2023

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