Bộ tài liệu hướng dẫn của ISPE (International Society for Pharmaceutical Engineering)

Các tài liệu hướng dẫn của ISPE được viết bởi các chuyên gia trong lĩnh vực sản xuất dược phẩm, sẽ cung cấp cho bạn những thông tin thực tế cần thiết để giúp công ty của mình xây dựng dựa trên các phương pháp tốt nhất để đáp ứng và vượt mức các tiêu chuẩn quy định bởi các cơ quan quản lý.

1. Product Quality Implementation Lifecycle (PQLI) Guides

- 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

2. Baseline Guides

- Baseline Guide Vol 1: Bulk Pharmaceutical Chemicals 1st edition (1996)

 

- Baseline Guide Vol 2: Oral Solid Dosage Forms: 2nd edition (2009), 3rd edition (2016)

- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 2nd edition (2011)

                      

- Baseline Guide Vol 4: Water & Steam Systems 1st edition (2001) & 2nd edition (2011)

- Baseline Guide Vol 5: Commissioning & Qualification 1st edition (2001) & 2nd edition (2019)

 

- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 1st (2004) & 2nd edition (2013)

- Baseline Guide Vol 7: Risk-Based Manufacture of Pharma Products: 1st edition (2010), 2nd edition (2017)

3. Good Practice Guides

- ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification (2011)

- ISPE Good Practice Guide: Approach to Commissioning and Qualification of Pharma Water & Steam Systems 2nd (2014)

- ISPE Good Practice Guide: Assessing Particulate Containment Performance of Pharmaceutical Equipment 2nd (2012)

- ISPE Good Practice Guide: Cold Chain Management

-  ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring (2016)

 

- ISPE Good Practice Guide: Good Engineering Practice 1st (2008), 2nd (2021)

- ISPE Good Practice Guide: Heating, Ventilation, & Air Conditioning (HVAC) 2009

- ISPE Good Practice Guide: HVAC & Process Equipment Air Filters 2019

- ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry (2021)

-  ISPE Good Practice Guide: Packaging, Labeling, & Warehousing Facilities (2012)

- ISPE Good Practice Guide: Practical Implementation of a Lifecycle Approach to Process Validation (2019)

- ISPE Good Practice Guide: Process Gases (2011)

- ISPE Good Practice Guide: Project Management for Pharmaceutical Industry (2011)

- ISPE Good Practice Guide: Quality Lab Facilities (2012)

- ISPE Good Practice Guide: Single-Use Technology (2018)

-  ISPE Good Practice Guide: Technology Transfer 1st (2003), 2nd (2014), 3rd Edition (2018)

4. Guides

- ISPE Guide: Biopharmaceutical Process Development and Manufacturing (2013)

- ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls (2020)

5. GAMP

- GAMP 5 Guide: Compliant GxP Computerized Systems

6. GAMP Good Practice Guide

- GAMP Good Practice Guide: IT Infrastructure Control and Compliance (2005)

- GAMP Good Practice Guide: Testing GxP Systems (2005)

- GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records (2019)

7. APQ Guide

- ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System (2020)

- ISPE APQ Guide: Management Responsibilities & Review