指南购买 Guidance Purchase

Good Practice Guide: HVAC & Process Equipment Air Filters

Just English Version。

Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC)

Just English Version。

Good Practice Guide: Harmonizing the Definition and Use of NIMPs

Good Practice Guide: Good Engineering Practice 2nd Edition

Good Practice Guide: Equipment Reliability

Good Practice Guide: Development of Investigational Therapeutic Biological Products

Good Practice Guide: Decommissioning Pharma Equipment & Facilities

Good Practice Guide: Critical Utilities GMP Compliance

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Containment for Potent Compounds

Good Practice Guide: Comparator Management

Good Practice Guide: Cold Chain Management

Good Practice Guide: Clinical Supply Systems

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

Good Practice Guide: Booklet Labels

Good Practice Guide: Asset Management

Good Practice Guide: Assessing Particulate Containment 2nd Edition

GAMP RDI Good Practice Guide: Data Integrity by Design

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

GAMP 5 Guide 2nd Edition

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

GAMP Good Practice Guide: Regulated Mobile Applications

GAMP Good Practice Guide: Operation of GxP Computerized Systems

GAMP Good Practice Guide: Manufacturing Execution Systems

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

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

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

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

GAMP Good Practice Guide: Enabling Innovation

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP5 第一版中文版

GAMP Good Practice Guide: Calibration Management 2nd Edition

GAMP Guide: Records & Data Integrity

APQ Guide: Cultural Excellence

Good Practice Guide: IMP Reverse Logistics

Good Practice Guide: Interactive Response Technology

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Good Practice Guide: Maintenance 2nd Edition

Good Practice Guide: Management of Engineering Standards

Good Practice Guide: Membrane-Based WFI Systems

Good Practice Guide: Operations Management

Good Practice Guide: Ozone Sanitization of Pharma Water Systems

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

Good Practice Guide: Process Gases 2nd Edition

Good Practice Guide: Process Validation English Version

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

中文版本

Good Practice Guide: Project Management for the Pharmaceutical Industry

Good Practice Guide: Quality Lab Facilities

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

Good Practice Guide: Single-Use Technology

Good Practice Guide: Technology Transfer 3rd Edition

Baseline Guide Vol 1: Active Pharmaceutical Ingredients

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

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

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

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

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

APQ Guide: Change Management (CM) System

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

APQ Guide: Management Responsibilities & Review (MRR)

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

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

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

PQLI Guide: Part 3 - Change Management System

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

Guide: ATMPs - Autologous Cell Therapy

Guide: Biopharmaceutical Process Development & Manufacturing

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

Handbook: Sustainability

Comprehensive Guide to Clinical Materials

Introductory US Clinical Trial Materials Training Guide

Investigational Materials Sample Retention Guide

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

Japan Affiliate: Pest Control Manual (English Translation)

2023 ISPE Drug Shortages Prevention Model

ISPE Readiness Report Bundle

The Cultural Excellence Report - Six Key Dimensions

Guide: 503B Compounding

Just English Version

Baseline Guide Vol 6 Biopharmaceutical Manufacturing Facilities 3rd Edition

English Version

Baseline Guide Vol 8: Pharma 4.0 1st Edition

GAMP Good Practice Guide: Manufacturing Execution Systems Chinese Ver.

Guide: ATMPs - Allogeneic Cell Therapy

Guide: ATMPs - rAAV Lifecycle Mgmt

Guide: 503A Compounding

具体如何获取，请见首页

ISPE Handbook: Sustainability