ISPE Shanghai

The International Society for Pharmaceutical Engineering is a not-for-profit association in America serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle.

Mission Statement
ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.

Vision Statement
Provide solutions to complex pharmaceutical industry challenges through manufacturing innovation, member and workforce development, technical, regulatory, and compliance collaboration.

Who We Are

ISPE is committed to the advancement of the educational and technical efficiency of its members through forums for the exchange of ideas and practical experience.

ISPE was founded in 1980 by a handful of people who believed the pharmaceutical industry needed an organization that would deal with practical applications of science and technology for technical professionals. The much-needed forum provided by ISPE began with a Membership of engineers in North America. In time, ISPE Membership expanded beyond engineering to include a broad representation from pharmaceutical professionals.

We lead and facilitate the development of next generation process technologies and innovative technical solutions. On matters of regulation, our focus is on those requirements that impact — or will impact — the licensing of facilities, manufacturing processes and operations, and the sustainability of the supply chain over the product lifecycle. ISPE provides a neutral environment where our individual Members and experts belonging to Regulatory Authorities can engage in open dialogue on issues that will ultimately benefit patients around the world.

ISPE provides support for the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF).

https://www.ispe.cn/

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Event Details

This activity is a guide to buying. More information about the guide can be found on the global website




You can also directly remit to Shanghai company :(please contact the staff in advance and fill in the purchase form)


公司抬头：上海埃思博益医药信息有限公司

账号：1001309909024212471

开户行：中国工商银行股份有限公司上海自贸试验区分行




Note:


1. Due to the epidemic, it may take one month to purchase the guide


2. Please fill in the form in English


3, can be issued general ticket, the content of consulting fees, after buying can contact LMiaoyi@ispe.org issued

Good Practice Guide: Operations Management

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Membrane-Based WFI Systems

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Management of Engineering Standards

Member PriceRMB 370
Public PriceRMB 1,460

Good Practice Guide: Maintenance 2nd Edition

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Knowledge Management in the Pharmaceutical Industry

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Interactive Response Technology

Member PriceRMB 530
Public PriceRMB 1,639

Good Practice Guide: IMP Reverse Logistics

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

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

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

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

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Harmonizing the Definition and Use of NIMPs

Member PriceRMB 370
Public PriceRMB 1,460

Good Practice Guide: Good Engineering Practice 2nd Edition

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Equipment Reliability

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Development of Investigational Therapeutic Biological Products

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Decommissioning Pharma Equipment & Facilities

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Critical Utilities GMP Compliance

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Member PriceRMB 1,080
Public PriceRMB 2,180

Good Practice Guide: Containment for Potent Compounds

Member PriceRMB 1,080
Public PriceRMB 2,175

Good Practice Guide: Comparator Management

Member PriceRMB 365
Public PriceRMB 1,460

Good Practice Guide: Cold Chain Management

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Clinical Supply Systems

Member PriceRMB 530
Public PriceRMB 1,630

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

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Booklet Labels

Member PriceRMB 365
Public PriceRMB 1,460

Good Practice Guide: Asset Management

Member PriceRMB 785
Public PriceRMB 1,880

Good Practice Guide: Assessing Particulate Containment 2nd Edition

Member PriceRMB 785
Public PriceRMB 1,880

GAMP RDI Good Practice Guide: Data Integrity by Design

Member PriceRMB 1,450
Public PriceRMB 2,540

GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records

Member PriceRMB 920
Public PriceRMB 2,010

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

Member PriceRMB 920
Public PriceRMB 2,010

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

Member PriceRMB 785
Public PriceRMB 1,880

GAMP Good Practice Guide: Regulated Mobile Applications

Member PriceRMB 785
Public PriceRMB 1,880

GAMP Good Practice Guide: Operation of GxP Computerized Systems

Member PriceRMB 785
Public PriceRMB 1,880

GAMP Good Practice Guide: Manufacturing Execution Systems

Member PriceRMB 785
Public PriceRMB 1,880

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

Member PriceRMB 785
Public PriceRMB 1,880

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

Member PriceRMB 785
Public PriceRMB 1,880

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

Member PriceRMB 785
Public PriceRMB 1,880

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

Member PriceRMB 785
Public PriceRMB 1,880

GAMP Good Practice Guide: Enabling Innovation

Member PriceRMB 1,080
Public PriceRMB 2,175

GAMP Good Practice Guide: Computerized GCP Systems & Data

Member PriceRMB 785
Public PriceRMB 1,880

GAMP Good Practice Guide: Calibration Management 2nd Edition

Member PriceRMB 785
Public PriceRMB 1,880

GAMP5 第一版中文版

Member PriceRMB 1,442
Public PriceRMB 2,537

GAMP 5 Guide 2nd Edition

Member PriceRMB 1,442
Public PriceRMB 2,537

GAMP Guide: Records & Data Integrity

Member PriceRMB 1,442
Public PriceRMB 2,537

Good Practice Guide: Ozone Sanitization of Pharma Water Systems

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Packaging, Labeling, & Warehousing Facilities

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Process Gases 2nd Edition

Member PriceRMB 1,100
Public PriceRMB 2,200

Good Practice Guide: Process Validation English Version

Member PriceRMB 790
Public PriceRMB 1,880

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

中文版本

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Project Management for the Pharmaceutical Industry

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Quality Lab Facilities

Member PriceRMB 790
Public PriceRMB 1,880

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

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Single-Use Technology

Member PriceRMB 790
Public PriceRMB 1,880

Good Practice Guide: Technology Transfer 3rd Edition

Member PriceRMB 790
Public PriceRMB 1,880

Baseline Guide Vol 1: Active Pharmaceutical Ingredients

Member PriceRMB 1,080
Public PriceRMB 2,180

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

Member PriceRMB 1,080
Public PriceRMB 2,180

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

Member PriceRMB 1,080
Public PriceRMB 2,180

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

Member PriceRMB 1,460
Public PriceRMB 2,540

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

Member PriceRMB 1,810
Public PriceRMB 2,910

Baseline Guide Vol 6 Biopharmaceutical Manufacturing Facilities 3rd Edition

English Version

Member PriceRMB 1,110
Public PriceRMB 2,236

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

Member PriceRMB 1,080
Public PriceRMB 2,180

Baseline Guide Vol 8: Pharma 4.0 1st Edition

Member PriceRMB 1,110
Public PriceRMB 2,230

APQ Guide: Cultural Excellence

Member PriceRMB 790
Public PriceRMB 1,880

APQ Guide: Change Management (CM) System

Member PriceRMB 790
Public PriceRMB 1,880

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

Member PriceRMB 790
Public PriceRMB 1,880

APQ Guide: Management Responsibilities & Review (MRR)

Member PriceRMB 790
Public PriceRMB 1,880

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

Member PriceRMB 790
Public PriceRMB 1,880

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

Member PriceRMB 790
Public PriceRMB 1,880

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

Member PriceRMB 790
Public PriceRMB 1,880

PQLI Guide: Part 3 - Change Management System

Member PriceRMB 390
Public PriceRMB 1,480

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

Member PriceRMB 390
Public PriceRMB 1,480

Guide: ATMPs - Autologous Cell Therapy

Member PriceRMB 1,450
Public PriceRMB 2,540

Guide: Biopharmaceutical Process Development & Manufacturing

Member PriceRMB 1,080
Public PriceRMB 2,180

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

Member PriceRMB 1,810
Public PriceRMB 2,910

Handbook: Sustainability

Member PriceRMB 360
Public PriceRMB 1,460

Comprehensive Guide to Clinical Materials

Member PriceRMB 550
Public PriceRMB 1,650

Introductory US Clinical Trial Materials Training Guide

Member PriceRMB 60
Public PriceRMB 95

Investigational Materials Sample Retention Guide

Member PriceRMB 25
Public PriceRMB 70

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

Member PriceRMB 550
Public PriceRMB 1,680

Japan Affiliate: Pest Control Manual (English Translation)

Member PriceRMB 550
Public PriceRMB 1,680

2023 ISPE Drug Shortages Prevention Model

Member PriceComplimentary
Public PriceRMB 550

ISPE Readiness Report Bundle

Member PriceComplimentary
Public PriceRMB 550

The Cultural Excellence Report - Six Key Dimensions

Member PriceComplimentary
Public PriceRMB 190

Guide: 503B Compounding

Just English Version

Member PriceRMB 1,080
Public PriceRMB 2,180

Introduction of Guidance Documents

良好实践指南:制药行业的知识管理（查看简介请点击指南封面）

制药用水系列指南（查看简介请点击指南封面）

良好实践指南：基于膜技术的注射用水（WFI）系统

ISPE 基本指南：第 4 卷 – 水和蒸汽系统（第三版）

ISPE 良好实践指南：制药用水和蒸汽系统的调试和确认方法 第二版

ISPE 良好实践指南：关键公用设施 GMP 合规性

ISPE 良好实践指南：制药用水系统的臭氧消毒

ISPE良好实践指南：温控箱/室（第 2 版）