ISPE Guidance Documents by Topic

• ACTIVE PHARMACEUTICAL INGREDIENTS
  • Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Maintenance
• BIOTECHNOLOGY
  • Biopharmaceutical Manufacturing Facilities (Second Edition)
  • Biopharmaceutical Process Development and Manufacturing
  • Maintenance
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement, Part 2: Product Realization using QbD, Illustrative Example
• CLEANING VALIDATION
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
• COMMISSIONING AND QUALIFICATION
  • Commissioning and Qualification of Pharma Water & Steam Systems 2nd Edition
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 1: Product Realization using QbD, Concepts and Principles
  • Product Quality Lifecycle Implementation (PQLI® ) from Concept to Continual Improvement Part 2: Product Realization using QbD, Illustrative Example
  • Baseline Guide Volume 5: Commissioning & Qualification 2nd Edition
• CONTAINMENT
  • Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Containment for Potent Compounds
  • ISPE D/A/CH Affiliate: Containment Manual (English Translation)
  • Maintenance
  • Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)
• CRITICAL UTILITIES
  • Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It
  • Ozone Sanitization of Pharmaceutical Water Systems
  • Process Gasses
  • Sampling for Pharmaceutical Water, Steam, and Process Gases
  • Water and Steam Systems (Second Edition)
• DISPOSABLES
  • Maintenance
• ENGINEERING STANDARDS BENCHMARKING
  • Good Engineering Practice
  • Management of Engineering Standards
• GAMP®
  • GAMP^® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • A Risk-Based Approach to Calibration Management (Second Edition)
  • A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • A Risk-Based Approach to GxP Process Control Systems (Second Edition)
  • A Risk-Based Approach to Operation of GxP Computerized Systems
  • A Risk-Based Approach to Regulated Mobile Applications
  • A Risk-Based Approach to Testing of GxP Systems (Second Edition)
  • Electronic Data Archiving
  • Global Information Systems Control and Compliance (Second Edition)
  • IT Infrastructure Control and Compliance (Second Edition)
  • Manufacturing Execution Systems – A Strategic and Program Management Approach
  • RDI Good Practice Guide: Data Integrity by Design
  • Records and Data Integrity
  • Validation and Compliance of Computerized GCP Systems & Data [Good eClinical Practice] 
• GOOD CONTROL LABORATORY PRACTICES
  • Maintenance
• HEATING, VENTILATION, AND AIR CONDITIONING
  • HVAC
  • Maintenance
• INVESTIGATIONAL PRODUCTS
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Clinical Supply Systems
  • Comparator Management
  • Development of Investigational Therapeutic Biological Products
  • Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs)
  • Interactive Response Technology
  • Maintenance
• OPERATIONS MANAGEMENT
  • Operations Management
• ORAL SOLID DOSAGE
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Oral Solid Dosage Forms (Third Edition)
• PACKAGING
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Cold Chain Management
  • Maintenance
  • Packaging, Labeling, and Warehousing Facilities (PACLAW)
• PROCESS ANALYTICAL TECHNOLOGY (PAT)
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Maintenance
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System
• PROCESS/PRODUCT DEVELOPMENT
  • Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Good Practice Guide: Technology Transfer 3rd Edition
  • Maintenance
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 1: Product Realization using QbD, Concepts and Principles
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 2: Product Realization using QbD, Illustrative Example
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System
  • Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 4: Process Performance and Product Quality Monitoring System (PP&PQMS)
• PROJECT MANAGEMENT
  • Good Engineering Practice
  • Maintenance
  • Project Management for the Pharmaceutical Industry
• QUALITY MANAGEMENT
  • APQ Guide: Corrective Action & Preventive Action (CAPA) System
• STERILE PRODUCTS PROCESSING (SPP)
  • Cleaning Validation Lifecycle - Applications, Methods, & Controls
  • Maintenance
  • Sterile-Product Manufacturing Facilities (Third Edition)
• SUSTAINABLE FACILITIES
  • Maintenance
  • Sustainability

Back to Top