تاریخچه استاندارد
ISPE   2023   Baseline Guide - Pharma 4.0 20000000 ریال
ISPE   2023   Baseline Guide volume 6 - Biopharmaceutical Manufacturing Facilities 20000000 ریال
ISPE   2023   Drug Shortages Prevention Model 20000000 ریال
ISPE   2023   Good Practice Guide - Process Gases 20000000 ریال
ISPE   2023   Guide - 503B Compounding - Regulatory basis and industry good practices for outsourcing facilities 20000000 ریال
ISPE   2023   Report on ISPE work to support establishment of the EU Health Emergency Preparedness and Response Authority (HERA) 20000000 ریال
ISPE   2022   Good Practice Guide - Membrane-Based Water for Injection Systems 20000000 ریال
ISPE   2022   Good Practice Guide - Containment for Potent Compounds 20000000 ریال
ISPE   2022   Good Practice Guide - Continuous Manufacturing of Oral Solid Dosage Forms 20000000 ریال
ISPE   2022   GAMP 5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems 20000000 ریال
ISPE   2022   APQ Guide Series - Process Performance and Product Quality Monitoring System 20000000 ریال
ISPE   2022   APQ Guide - Change Management System 20000000 ریال
ISPE   2022   APQ Guide - Cultural Excellence 20000000 ریال
ISPE   2021   APQ Guide - Management responsibilities and management review 20000000 ریال
ISPE   2021   GAMP Good Practice Guide - Enabling Innovation 20000000 ریال
ISPE   2021   Good Practice Guide - Controlled Temperature Chambers 20000000 ریال
ISPE   2021   Good Practice Guide - Good Engineering Practice 20000000 ریال
ISPE   2021   Good Practice Guide - Investigational Medicinal Product Reverse Logistics 20000000 ریال
ISPE   2021   Good Practice Guide - Knowledge Management in the Pharmaceutical Industry 20000000 ریال
ISPE   2021   Good Practice Guide - Maintenance 20000000 ریال
ISPE   2021   Guide - Advanced Therapy Medicinal Products - Autologous Cell Therapy 20000000 ریال
ISPE   2020   Guide - Cleaning Validation Lifecycle - Applications, Methods, and Controls 20000000 ریال
ISPE   2020   Increasing Domestic Resiliency in the Supply of Essential Active Pharmaceutical Ingredients 20000000 ریال
ISPE   2020   Good Practice Guide - Equipment Reliability 20000000 ریال
ISPE   2020   Good Practice Guide - Critical Utilities GMP Compliance 20000000 ریال
ISPE   2020   GAMP RDI Good Practice Guide - Data Integrity by Design 20000000 ریال
ISPE   2020   APQ Guide Series - Corrective Action and Preventive Action (CAPA) System 20000000 ریال
ISPE   2019   Baseline Guide volume 4 - Water and Steam Systems 20000000 ریال
ISPE   2019   Baseline Guide volume 5 - Commissioning and Qualification 20000000 ریال
ISPE   2019   GAMP RDI Good Practice Guide - Data Integrity - Manufacturing Records 20000000 ریال
ISPE   2019   Good Practice Guide - Asset Management 20000000 ریال
ISPE   2019   Good Practice Guide - HVAC and Process Equipment Air Filters 20000000 ریال
ISPE   2019   Good Practice Guide - Practical Implementation of the Lifecycle Approach to Process Validation 20000000 ریال
ISPE   2018   Good Practice Guide - Single-Use Technology 20000000 ریال
ISPE   2018   Good Practice Guide - Technology Transfer 20000000 ریال
ISPE   2018   GAMP RDI Good Practice Guide - Data Integrity - Key Concepts 20000000 ریال
ISPE   2018   Baseline Guide volume 3 - Sterile Product Manufacturing Facilities 20000000 ریال
ISPE   2017   Cultural Excellence Report 20000000 ریال
ISPE   2017   GAMP Good Practice Guide - Global Information Systems Control and Compliance 20000000 ریال
ISPE   2017   GAMP Good Practice Guide - IT Infrastructure Control and Compliance 20000000 ریال
ISPE   2017   GAMP Good Practice Guide - Validation and Compliance of Computerized GCP Systems and Data 20000000 ریال
ISPE   2017   GAMP Guide - Records and Data Integrity 20000000 ریال
ISPE   2017   Baseline Guide volume 7 - Risk-Based Manufacture of Pharmaceutical Products 20000000 ریال
ISPE   2017   Good Practice Guide - Decommissioning of Pharmaceutical Equipment and Facilities 20000000 ریال
ISPE   2016   Good Practice Guide - Sampling for Pharmaceutical Water, Steam, and Process Gases 20000000 ریال
ISPE   2016   Good Practice Guide - Management of Engineering Standards 20000000 ریال
ISPE   2016   Good Practice Guide - Operations Management 20000000 ریال
ISPE   2016   Baseline Guide volume 2 - Oral Solid Dosage Forms 20000000 ریال
ISPE   2015   Handbook - Sustainability 20000000 ریال
ISPE   2014   GAMP Good Practice Guide - A Risk-Based Approach to Regulated Mobile Applications 20000000 ریال
ISPE   2014   Good Practice Guide - Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems 20000000 ریال
ISPE   2014   Good Practice Guide - Clinical Supply Systems 20000000 ریال
ISPE   2013   Good Practice Guide - Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) 20000000 ریال
ISPE   2013   Good Practice Guide - Booklet Labels 20000000 ریال
ISPE   2013   Guide - Biopharmaceutical Process Development and Manufacturing 20000000 ریال
ISPE   2012   Guide Series PQLI Part 3 - Change Management System as a Key Element of a Pharmaceutical Quality System 20000000 ریال
ISPE   2012   Guide Series PQLI Part 4 - Process Performance and Product Quality Monitoring System 20000000 ریال
ISPE   2012   Good Practice Guide - Assessing the particulate containment performance of pharmaceutical equipment 20000000 ریال
ISPE   2012   Good Practice Guide - Comparator Management 20000000 ریال
ISPE   2012   Good Practice Guide - Ozone Sanitization of Pharmaceutical Water Systems 20000000 ریال
ISPE   2012   Good Practice Guide - Packaging, Labeling, and Warehousing Facilities 20000000 ریال
ISPE   2012   Good Practice Guide - Quality Laboratory Facilities 20000000 ریال
ISPE   2012   GAMP Good Practice Guide - A Risk-Based Approach to Testing of GxP Systems 20000000 ریال
ISPE   2012   GAMP Good Practice Guide - A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems 20000000 ریال
ISPE   2011   GAMP Good Practice Guide - A Risk-Based Approach to GxP Process Control Systems 20000000 ریال
ISPE   2011   Good Practice Guide - Applied Risk Management for Commissioning and Qualification 20000000 ریال
ISPE   2011   Good Practice Guide - Process Gases 20000000 ریال
ISPE   2011   Good Practice Guide - Project Management for the Pharmaceutical Industry 20000000 ریال
ISPE   2011   Good Practice Guide - Cold Chain Management 20000000 ریال
ISPE   2011   Good Practice Guide - Interactive Response Technology 20000000 ریال
ISPE   2011   Guide - Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment 20000000 ریال
ISPE   2011   Guide Series PQLI Part 1 - Product Realization using Quality by Design (QbD) - Concepts and Principles 20000000 ریال
ISPE   2011   Guide Series PQLI Part 2 - Product Realization using Quality by Design (QbD) - Illustrative Example 20000000 ریال
ISPE   2010   GAMP Good Practice Guide - Manufacturing Execution Systems - A Strategic and Program Management Approach 10000000 ریال
ISPE   2010   GAMP Good Practice Guide - A Risk-Based Approach to Calibration Management 10000000 ریال
ISPE   2009   GAMP Good Practice Guide - A Risk-Based Approach to Operation of GxP Computerized Systems 10000000 ریال
ISPE   2009   Good Practice Guide - Heating, Ventilation, and Air Conditioning 10000000 ریال
ISPE   2007   Good Practice Guide - Development of Investigational Therapeutic Biological Products 10000000 ریال
ISPE   2007   GAMP Good Practice Guide - Electronic Data Archiving 10000000 ریال
ISPE   2007   Baseline Guide volume 1 - Active Pharmaceutical Ingredients 10000000 ریال
ISPE   2006   Comprehensive Guide to Clinical Materials 10000000 ریال
ISPE   2005   GAMP Good Practice Guide - A Risk-Based Approach to Compliant Electronic Records and Signatures 10000000 ریال

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