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ISPE   2023   Baseline Guide - Pharma 4.0 200 $
ISPE   2023   Baseline Guide volume 6 - Biopharmaceutical Manufacturing Facilities 200 $
ISPE   2023   Drug Shortages Prevention Model 200 $
ISPE   2023   Good Practice Guide - Process Gases 200 $
ISPE   2023   Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 200 $
ISPE   2023   Report on ISPE work to support establishment of the EU Health Emergency Preparedness and Response Authority (HERA) 200 $
ISPE   2022   Good Practice Guide - Membrane-Based Water for Injection Systems 200 $
ISPE   2022   Good Practice Guide - Containment for Potent Compounds 200 $
ISPE   2022   Good Practice Guide - Continuous Manufacturing of Oral Solid Dosage Forms 200 $
ISPE   2022   GAMP 5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems 200 $
ISPE   2022   APQ Guide Series - Process Performance and Product Quality Monitoring System 200 $
ISPE   2022   APQ Guide - Change Management System 200 $
ISPE   2022   APQ Guide - Cultural Excellence 200 $
ISPE   2021   APQ Guide - Management responsibilities and management review 200 $
ISPE   2021   GAMP Good Practice Guide - Enabling Innovation 200 $
ISPE   2021   Good Practice Guide - Controlled Temperature Chambers 200 $
ISPE   2021   Good Practice Guide - Good Engineering Practice 200 $
ISPE   2021   Good Practice Guide - Investigational Medicinal Product Reverse Logistics 200 $
ISPE   2021   Good Practice Guide - Knowledge Management in the Pharmaceutical Industry 200 $
ISPE   2021   Good Practice Guide - Maintenance 200 $
ISPE   2021   Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 200 $
ISPE   2020   Guide - Cleaning Validation Lifecycle - Applications, Methods, and Controls 200 $
ISPE   2020   Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients 200 $
ISPE   2020   Good Practice Guide - Equipment Reliability 200 $
ISPE   2020   Good Practice Guide - Critical Utilities GMP Compliance 200 $
ISPE   2020   GAMP RDI Good Practice Guide - Data Integrity by Design 200 $
ISPE   2020   APQ Guide Series - Corrective Action and Preventive Action (CAPA) System 200 $
ISPE   2019   Baseline Guide volume 4 - Water and Steam Systems 200 $
ISPE   2019   Baseline Guide volume 5 - Commissioning and Qualification 200 $
ISPE   2019   GAMP RDI Good Practice Guide - Data Integrity - Manufacturing Records 200 $
ISPE   2019   Good Practice Guide - Asset Management 200 $
ISPE   2019   Good Practice Guide - HVAC and Process Equipment Air Filters 200 $
ISPE   2019   Good Practice Guide - Practical Implementation of the Lifecycle Approach to Process Validation 200 $
ISPE   2018   Good Practice Guide - Single-Use Technology 200 $
ISPE   2018   Good Practice Guide - Technology Transfer 200 $
ISPE   2018   GAMP RDI Good Practice Guide - Data Integrity - Key Concepts 200 $
ISPE   2018   Baseline Guide volume 3 - Sterile Product Manufacturing Facilities 200 $
ISPE   2017   Cultural Excellence Report 200 $
ISPE   2017   GAMP Good Practice Guide - Global Information Systems Control and Compliance 200 $
ISPE   2017   GAMP Good Practice Guide - IT Infrastructure Control and Compliance 200 $
ISPE   2017   GAMP Good Practice Guide - Validation and Compliance of Computerized GCP Systems and Data 200 $
ISPE   2017   GAMP Guide - Records and Data Integrity 200 $
ISPE   2017   Baseline Guide volume 7 - Risk-Based Manufacture of Pharmaceutical Products 200 $
ISPE   2017   Good Practice Guide - Decommissioning of Pharmaceutical Equipment and Facilities 200 $
ISPE   2016   Good Practice Guide - Sampling for Pharmaceutical Water, Steam, and Process Gases 200 $
ISPE   2016   Good Practice Guide - Management of Engineering Standards 200 $
ISPE   2016   Good Practice Guide - Operations Management 200 $
ISPE   2016   Baseline Guide volume 2 - Oral Solid Dosage Forms 200 $
ISPE   2015   Handbook - Sustainability 200 $
ISPE   2014   GAMP Good Practice Guide - A Risk-Based Approach to Regulated Mobile Applications 200 $
ISPE   2014   Good Practice Guide - Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems 200 $
ISPE   2014   Good Practice Guide - Clinical Supply Systems 200 $
ISPE   2013   Good Practice Guide - Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) 200 $
ISPE   2013   Good Practice Guide - Booklet Labels 200 $
ISPE   2013   Guide - Biopharmaceutical Process Development and Manufacturing 200 $
ISPE   2012   Guide Series PQLI Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System 200 $
ISPE   2012   Guide Series PQLI Part 4 - Process Performance and Product Quality Monitoring System 200 $
ISPE   2012   Good Practice Guide - Assessing the particulate containment performance of pharmaceutical equipment 200 $
ISPE   2012   Good Practice Guide - Comparator Management 200 $
ISPE   2012   Good Practice Guide - Ozone Sanitization of Pharmaceutical Water Systems 200 $
ISPE   2012   Good Practice Guide - Packaging, Labeling, and Warehousing Facilities 200 $
ISPE   2012   Good Practice Guide - Quality Laboratory Facilities 200 $
ISPE   2012   GAMP Good Practice Guide - A Risk-Based Approach to Testing of GxP Systems 200 $
ISPE   2012   GAMP Good Practice Guide - A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems 200 $
ISPE   2011   GAMP Good Practice Guide - A Risk-Based Approach to GxP Process Control Systems 200 $
ISPE   2011   Good Practice Guide - Applied Risk Management for Commissioning and Qualification 200 $
ISPE   2011   Good Practice Guide - Process Gases 200 $
ISPE   2011   Good Practice Guide - Project Management for the Pharmaceutical Industry 200 $
ISPE   2011   Good Practice Guide - Cold Chain Management 200 $
ISPE   2011   Good Practice Guide - Interactive Response Technology 200 $
ISPE   2011   Guide - Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment 200 $
ISPE   2011   Guide Series PQLI Part 1 - Product Realization using Quality by Design (QbD) - Concepts and Principles 200 $
ISPE   2011   Guide Series PQLI Part 2 - Product Realization using Quality by Design (QbD) - Illustrative Example 200 $
ISPE   2010   GAMP Good Practice Guide - Manufacturing Execution Systems - A Strategic and Program Management Approach 100 $
ISPE   2010   GAMP Good Practice Guide - A Risk-Based Approach to Calibration Management 100 $
ISPE   2009   GAMP Good Practice Guide - A Risk-Based Approach to Operation of GxP Computerized Systems 100 $
ISPE   2009   Good Practice Guide - Heating, Ventilation, and Air Conditioning 100 $
ISPE   2007   Good Practice Guide - Development of Investigational Therapeutic Biological Products 100 $
ISPE   2007   GAMP Good Practice Guide - Electronic Data Archiving 100 $
ISPE   2007   Baseline Guide volume 1 - Active Pharmaceutical Ingredients 100 $
ISPE   2006   Comprehensive Guide to Clinical Materials 100 $
ISPE   2005   GAMP Good Practice Guide - A Risk-Based Approach to Compliant Electronic Records and Signatures 100 $