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