Good Practice Guide: Digital Validation

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Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms，Just English Version。

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Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms，Just English Version。

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Good Practice Guide: Harmonizing the Definition and Use of NIMPs

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Good Practice Guide: Good Engineering Practice 2nd Edition

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Good Practice Guide: Equipment Reliability

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Good Practice Guide: Development of Investigational Therapeutic Biological Products

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Good Practice Guide: Decommissioning Pharma Equipment & Facilities

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Good Practice Guide: Critical Utilities GMP Compliance

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Good Practice Guide: Controlled Temperature Chambers 2nd Edition

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Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

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Good Practice Guide: Containment for Potent Compounds

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Good Practice Guide: Comparator Management

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Good Practice Guide: Cold Chain Management

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Good Practice Guide: Clinical Supply Systems

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Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition

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Good Practice Guide: Booklet Labels

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Good Practice Guide: Asset Management

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Good Practice Guide: Assessing Particulate Containment 2nd Edition

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GAMP RDI Good Practice Guide: Data Integrity by Design

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GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

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GAMP 5 Guide 2nd Edition

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GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

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GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

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GAMP Good Practice Guide: Regulated Mobile Applications

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GAMP Good Practice Guide: Operation of GxP Computerized Systems

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GAMP Good Practice Guide: Manufacturing Execution Systems

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GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition

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GAMP Good Practice Guide: GxP Process Control Systems 2nd Edition

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GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition

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GAMP Good Practice Guide: Global Info Systems Control & Compliance 2nd Edition

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GAMP Good Practice Guide: Enabling Innovation

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GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition

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GAMP5 第一版中文版

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GAMP Good Practice Guide: Calibration Management 2nd Edition

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GAMP Guide: Records & Data Integrity

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APQ Guide: Cultural Excellence

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Good Practice Guide: IMP Reverse Logistics

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Good Practice Guide: Interactive Response Technology

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Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

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Good Practice Guide: Maintenance 2nd Edition

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Good Practice Guide: Management of Engineering Standards

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Good Practice Guide: Membrane-Based WFI Systems

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Good Practice Guide: Operations Management

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Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition

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Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

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Good Practice Guide: Process Gases 2nd Edition

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Good Practice Guide: Process Validation English Version

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ISPE Good Practice Guide: 践行生命周期模式的工艺验证指南

中文版本

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Good Practice Guide: Project Management for the Pharmaceutical Industry

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Good Practice Guide: Quality Lab Facilities

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Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases

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Good Practice Guide: Single-Use Technology

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Good Practice Guide: Technology Transfer 3rd Edition

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Baseline Guide Vol 1: Active Pharmaceutical Ingredients

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Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition

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Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition

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Baseline Guide Vol 4: Water & Steam Systems 3rd Edition

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Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

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Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products 2nd Edition

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APQ Guide: Change Management (CM) System

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APQ Guide: Corrective Action & Preventive Action (CAPA) System

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APQ Guide: Management Responsibilities & Review (MRR)

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APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)

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PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles

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PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example

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PQLI Guide: Part 3 - Change Management System

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PQLI Guide: Part 4 - Process Performance & Product Quality Monitoring System

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Guide: ATMPs - Autologous Cell Therapy

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Guide: Biopharmaceutical Process Development & Manufacturing

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Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

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Handbook: Sustainability

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Comprehensive Guide to Clinical Materials

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Introductory US Clinical Trial Materials Training Guide

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Investigational Materials Sample Retention Guide

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D/A/CH Affiliate: WFI Handbook (English Translation)

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Japan Affiliate: Pest Control Manual (English Translation)

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2023 ISPE Drug Shortages Prevention Model

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ISPE Readiness Report Bundle

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The Cultural Excellence Report - Six Key Dimensions

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Guide: 503B Compounding

Just English Version

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Baseline Guide Vol 6 Biopharmaceutical Manufacturing Facilities 3rd Edition

English Version

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Baseline Guide Vol 8: Pharma 4.0 1st Edition

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GAMP Good Practice Guide: Manufacturing Execution Systems Chinese Ver.

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Guide: ATMPs - Allogeneic Cell Therapy

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Guide: ATMPs - rAAV Lifecycle Mgmt

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Guide: 503A Compounding

具体如何获取，请见首页

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ISPE Handbook: Sustainability

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Good Practice Guide: Unique ID of Glass Primary Containers

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Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition

Just English Version

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Good Practice Guide: Validation 4.0

Just English Version

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GAMP Guide: Artificial Intelligence

此指南为英文电子版

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Guide: Sustainability

此指南只有英文电子版本

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Good Practice Guide: C&Q of Water & Steam Systems 3rd Edition

此指南只有英文电子版

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