Guidance Documents

Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the practical, "real world" information you need to stay current with industry best practices and regulatory expectations. ISPE Members receive a discount on Guidance Documents.

GAMP

GAMP 5 Guide 2nd Edition

GAMP Guide: Records & Data Integrity

GAMP Good Practice Guides

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
Reflecting current regulatory expectations and good practices for automated/computerized systems, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

GAMP Good Practice Guide: Calibration Management 2nd Edition

GAMP Good Practice Guide: Computerized GCP Systems & Data

GAMP Good Practice Guide: Enabling Innovation.

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

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

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

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

GAMP Good Practice Guide: Manufacturing Execution Systems

GAMP Good Practice Guide: Operation of GxP Computerized Systems

GAMP Good Practice Guide: Regulated Mobile Applications

GAMP Good Practice Guide: Testing GxP Systems 2nd Edition

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

GAMP RDI Good Practice Guide: Data Integrity by Design

ISPE GAMP RDI Good Practice GAMP Good Practice Guide: Data Integrity - Manufacturing Records

Good Practice Guides

Reflecting current regulatory expectations and best practices, Good Practice Guides (GPGs) help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

Good Practice Guide: Assessing Particulate Containment 2nd Edition

Good Practice Guide: Asset Management

Good Practice Guide: Booklet Labels

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

Good Practice Guide: Clinical Supply Systems

Good Practice Guide: Cold Chain Management

Good Practice Guide: Comparator Management

Good Practice Guide: Containment for Potent Compounds

Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

Good Practice Guide: Controlled Temperature Chambers 2nd Edition

Good Practice Guide: Critical Utilities GMP Compliance

Good Practice Guide: Decommissioning Pharma Equipment & Facilities

Good Practice Guide: Development of Investigational Therapeutic Biological Products

Good Practice Guide: Equipment Reliability

Good Practice Guide: Good Engineering Practice 2nd Edition

Good Practice Guide: Harmonizing the Definition and Use of NIMPs

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

Good Practice Guide: HVAC & Process Equipment Air Filters

Good Practice Guide: IMP Reverse Logistics

Good Practice Guide: Interactive Response Technology

Good Practice Guide: Knowledge Management in 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

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 Guides

Created with input from various global regulatory agencies, Baseline Guides are intended to establish a compliant minimum acceptable (baseline) approach to the topic area. They typically focus on the “what”.

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 6: Biopharmaceutical Manufacturing Facilities 3rd Edition

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

Baseline Guide Vol 8: Pharma 4.0 1st Edition

Guides

Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.

Guide: 503A Compounding

Guide: 503B Compounding

Guide: ATMPs - Allogeneic Cell Therapy

Guide: ATMPs - Autologous Cell Therapy

Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt

Guide: Biopharmaceutical Process Development & Manufacturing

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

APQ

APQ Guide: Change Management (CM) System

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

APQ Guide: Cultural Excellence

APQ Guide: Management Responsibilities & Review (MRR)

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

PQLI

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

Handbooks

Handbooks provide a comprehensive ready reference, with concise information on a particular topic, occupation, or process. They are structured to give quick answers in specific topic areas.

Handbook: Sustainability

IP Publications

Comprehensive Guide to Clinical Materials

Introductory US Clinical Trial Materials Training Guide

Affiliate Publications

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

Japan Affiliate: Pest Control Manual (English Translation)

Initiatives

2023 ISPE Drug Shortages Prevention Model

ISPE Readiness Report Bundle

The Cultural Excellence Report - Six Key Dimensions