ISPE Guidance Documents by Topic

1. ACTIVE PHARMACEUTICAL INGREDIENTS

2. BIOTECHNOLOGY

3. CLEANING VALIDATION

4. COMMISSIONING AND QUALIFICATION

5. CONTAINMENT

6. CRITICAL UTILITIES

7. DISPOSABLES

8. ENGINEERING STANDARDS BENCHMARKING

9. GAMP®

10. GOOD CONTROL LABORATORY PRACTICES

11. HEATING, VENTILATION, AND AIR CONDITIONING

12. INVESTIGATIONAL PRODUCTS

13. OPERATIONS MANAGEMENT

14. ORAL SOLID DOSAGE

15. PACKAGING

16. PROCESS ANALYTICAL TECHNOLOGY (PAT)

17. PROCESS/PRODUCT DEVELOPMENT

18. PROJECT MANAGEMENT

19. QUALITY MANAGEMENT

20. STERILE PRODUCTS PROCESSING (SPP)

21. SUSTAINABLE FACILITIES

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Topic Guideline Name Publication details

Active Pharmaceutical
Ingredients (Second Baseline Guide Vol 1:
Published: June 2007
Edition) - Revision to Active Pharmaceutical
Pages: 188
Bulk Pharmaceutical Ingredients
Chemicals
ACTIVE
PHARMACEUTICAL Guide: Cleaning
Cleaning Validation
INGREDIENTS Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
Controls

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132

Baseline Guide Vol 6:

Biopharmaceutical Published: November
Biopharmaceutical
Manufacturing Facilities 2023
Manufacturing Facilities
(Second Edition) Pages: 194
3rd Edition

Guide:
Biopharmaceutical
Biopharmaceutical Published: October 2013
Process Development
Process Development & Pages: 228
and Manufacturing
Manufacturing

Good Practice Guide: Published: January 2021

BIOTECHNOLOGY Maintenance
Maintenance 2nd Edition Pages: 132

Product Quality
Lifecycle
Implementation (PQLI®) PQLI Guide: Part 2 -
Published: November
from Concept to Product Realization
2011
Continual Improvement, using QbD: Illustrative
Pages: 232
Part 2: Product Example
Realization using QbD,
Illustrative Example

Guide: Cleaning
Cleaning Validation Published: August 2020
CLEANING Validation Lifecycle -
Lifecycle - Applications, Pages: 236
VALIDATION Applications, Methods, &
Methods, & Controls
Controls

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Topic Guideline Name Publication details

Commissioning and Good Practice Guide:

Qualification of Pharma C&Q of Pharma Water & Published: July 2014
Water & Steam Systems Steam Systems 2nd Pages: 120
2nd Edition Edition

Product Quality
Lifecycle
Implementation (PQLI®) PQLI Guide: Part 1 -
Published: November
from Concept to Product Realization
2011
Continual Improvement using QbD: Concepts &
Pages: 188
Part 1: Product Principles
Realization using QbD,
Concepts and Principles

COMMISSIONING Product Quality

AND Lifecycle
QUALIFICATION Implementation (PQLI® PQLI Guide: Part 2 -
Published: November
) from Concept to Product Realization
2011
Continual Improvement using QbD: Illustrative
Pages: 232
Part 2: Product Example
Realization using QbD,
Illustrative Example

Baseline Guide Volume Baseline Guide Vol 5:

Published: June 2019
5: Commissioning & Commissioning &
Pages: 212
Qualification 2nd Edition Qualification 2nd Edition

Commissioning and Good Practice Guide:

Qualification of Pharma C&Q of Pharma Water & Published: July 2014
Water & Steam Systems Steam Systems 2nd Pages: 120
2nd Edition Edition

Assessing the
Particulate Containment Good Practice Guide:
Performance of Assessing Particulate Published: May 2012
Pharmaceutical Containment 2nd Pages: 104
Equipment (Second Edition..
Edition)

Guide: Cleaning
Cleaning Validation
Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
CONTAINMENT Controls

Good Practice Guide: Published: December

Containment for Potent
Containment for Potent 2022
Compounds
Compounds Pages: 258

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132

Baseline Guide Vol 7:

Risk-Based Manufacture
Risk-Based Manufacture Published: July 2017
of Pharmaceutical
of Pharma Products 2nd Pages: 182
Products (Risk-MaPP)
Edition

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Topic Guideline Name Publication details

Critical Utilities GMP

Good Practice Guide:
Compliance – How to Published: June 2020
Critical Utilities GMP
Be Compliant and Pages: 100
Compliance
Ready to Prove It

Ozone Sanitization of Good Practice Guide:

Published: July 2012
Pharmaceutical Water Ozone Sanitization of
Pages: 144
Systems Pharma Water Systems

CRITICAL UTILITIES Good Practice Guide:

Published: October 2023
Process Gasses Process Gases 2nd
Pages: 152
Edition

Sampling for
Good Practice Guide: Published: December
Pharmaceutical Water,
Sampling Pharma Water, 2016
Steam, and Process
Steam, & Process Gases Pages: 122
Gases

Water and Steam Baseline Guide Vol 4: Published: September

Systems (Second Water & Steam Systems 2019
Edition) 3rd Edition Pages: 280

Good Practice Guide: Published: January 2021

DISPOSABLES Maintenance
Maintenance 2nd Edition Pages: 132

Good Practice Guide:

Good Engineering Published: October 2021
Good Engineering
Practice Pages: 244
ENGINEERING Practice 2nd Edition
STANDARDS
BENCHMARKING Good Practice Guide:
Management of Published: August 2016
Management of
Engineering Standards Pages: 52
Engineering Standards

GAMP® 5: A Risk-Based
Approach to Compliant GAMP 5 Guide 2nd Published: July 2022
GxP Computerized Edition Pages: 404
Systems

A Risk-Based Approach
GAMP Good Practice Published: November
to Calibration
Guide: Calibration 2010
Management (Second
Management 2nd Edition Pages: 124
Edition)

A Risk-Based Approach GAMP Good Practice

to GxP Compliant Guide: GxP Compliant
GAMP® Published: October 2012
Laboratory Laboratory
Pages: 160
Computerized Systems Computerized Systems
(Second Edition) 2nd Edition

A Risk-Based Approach GAMP Good Practice

Published: February
to GxP Process Control Guide: GxP Process
2011
Systems (Second Control Systems 2nd
Pages: 196
Edition) Edition

A Risk-Based Approach GAMP Good Practice

Published: January 2010
to Operation of GxP Guide: Operation of GxP
Pages: 216
Computerized Systems Computerized Systems

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Topic Guideline Name Publication details

A Risk-Based Approach GAMP Good Practice

Published: October 2014
to Regulated Mobile Guide: Regulated Mobile
Pages: 96
Applications Applications

A Risk-Based Approach
GAMP Good Practice Published: February
to Testing of GxP
Guide: Testing GxP 2012
Systems (Second
Systems 2nd Edition Pages: 265
Edition)

Global Information GAMP Good Practice

Published: February
Systems Control and Guide: Global Info
2017
Compliance (Second Systems Control &
Pages: 164
Edition) Compliance 2nd Edition

GAMP Good Practice

IT Infrastructure Control
Guide: IT Infrastructure Published: August 2017
and Compliance
Control & Compliance Pages: 168
(Second Edition)
2nd Edition

Manufacturing Published: February

GAMP Good Practice
Execution Systems – A 2010
Guide: Manufacturing
Strategic and Program Pages: 144
Execution Systems
Management Approach

RDI Good Practice GAMP RDI Good

Published: October 2020
Guide: Data Integrity by Practice Guide: Data
Pages: 176
Design Integrity by Design

Records and Data GAMP Guide: Records & Published: March 2017
Integrity Data Integrity Pages: 152

Validation and
Compliance of
Computerized GCP
Systems & Data [Good
eClinical Practice]

GAMP® 5: A Risk-Based
Approach to Compliant GAMP 5 Guide 2nd Published: July 2022
GxP Computerized Edition Pages: 404
Systems

GOOD CONTROL
Good Practice Guide: Published: January 2021
LABORATORY Maintenance
Maintenance 2nd Edition Pages: 132
PRACTICES

Good Practice Guide: Published: September

HVAC Heating, Ventilation, & 2009
HEATING,
Air Conditioning (HVAC) Pages: 288
VENTILATION, AND
AIR CONDITIONING
Good Practice Guide: Published: January 2021
Maintenance
Maintenance 2nd Edition Pages: 132

INVESTIGATIONAL Guide: Cleaning

Cleaning Validation
PRODUCTS Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
Controls

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Topic Guideline Name Publication details

Good Practice Guide: Published: March 2014

Clinical Supply Systems
Clinical Supply Systems Pages: 118

Published: February
Good Practice Guide:
Comparator 2012
Comparator
Management Pages: 84
Management

Good Practice Guide:

Development of
Development of
Investigational Published: August 2007
Investigational
Therapeutic Biological Pages: 92
Therapeutic Biological
Products
Products

Harmonizing the
Good Practice Guide:
Definition and Use of
Harmonizing the Published: January 2013
Non-Investigational
Definition and Use of Pages: 56
Medicinal Products
NIMPs
(NIMPs)

Good Practice Guide: Published: November

Interactive Response
Interactive Response 2011
Technology
Technology Pages: 92

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132

OPERATIONS Operations Good Practice Guide: Published: April 2016

MANAGEMENT Management Operations Management Pages: 166

Cleaning Validation
Lifecycle - Applications,
ORAL SOLID Methods, & Controls
DOSAGE
Baseline Guide Vol 2: Published: November
Oral Solid Dosage
Oral Solid Dosage 2016
Forms (Third Edition)
Forms 3rd Edition Pages: 240

Guide: Cleaning
Cleaning Validation
Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
Controls

Cold Chain Good Practice Guide: Published: May 2011

PACKAGING Management Cold Chain Management Pages: 140

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132

Packaging, Labeling, Good Practice Guide:

Published: June 2012
and Warehousing Packaging, Labeling, &
Pages: 112
Facilities (PACLAW) Warehousing Facilities

Guide: Cleaning
PROCESS Cleaning Validation
Validation Lifecycle - Published: August 2020
ANALYTICAL Lifecycle - Applications,
Applications, Methods, & Pages: 236
TECHNOLOGY (PAT) Methods, & Controls
Controls

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Topic Guideline Name Publication details

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132
Product Quality
Lifecycle
Implementation (PQLI®)
from Concept to
PQLI Guide: Part 3 -
Continual Improvement Published: June 2012
Change Management
Part 3: Change Pages: 56
System
Management System as
a Key Element of a
Pharmaceutical Quality
System
Approaches to
Commissioning and Good Practice Guide:
Qualification of C&Q of Pharma Water & Published: July 2014
Pharmaceutical Water Steam Systems 2nd Pages: 120
and Steam Systems Edition
(Second Edition)

Guide: Cleaning
Cleaning Validation
Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
Controls

Good Practice Guide: Good Practice Guide: Published: December

Technology Transfer 3rd Technology Transfer 3rd 2018
Edition Edition Pages: 152

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132

Product Quality
Lifecycle
PROCESS/PRODUCT Implementation (PQLI®) PQLI Guide: Part 1 -
DEVELOPMENT Published: November
from Concept to Product Realization
2011
Continual Improvement using QbD: Concepts &
Pages: 188
Part 1: Product Principles
Realization using QbD,
Concepts and Principles

Product Quality
Lifecycle
Implementation (PQLI®) PQLI Guide: Part 2 -
Published: November
from Concept to Product Realization
2011
Continual Improvement using QbD: Illustrative
Pages: 232
Part 2: Product Example
Realization using QbD,
Illustrative Example

Product Quality
Lifecycle
Implementation (PQLI®) PQLI Guide: Part 3 -
Published: June 2012
from Concept to Change Management
Pages: 56
Continual Improvement System
Part 3: Change
Management System as

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Topic Guideline Name Publication details

a Key Element of a
Pharmaceutical Quality
System

Product Quality
Lifecycle
Implementation (PQLI®) PQLI Guide: Part 4 -
from Concept to Process Performance &
Continual Improvement Published: June 2013
Product Quality
Part 4: Process Monitoring System Pages: 80
Performance and
Product Quality
Monitoring System
(PP&PQMS)

Good Practice Guide:

Good Engineering Published: October 2021
Good Engineering
Practice Pages: 244
Practice 2nd Edition

Good Practice Guide: Published: January 2021

PROJECT Maintenance
Maintenance 2nd Edition Pages: 132
MANAGEMENT
Good Practice Guide:
Project Management for Published: November
Project Management for
the Pharmaceutical 2011
the Pharmaceutical
Industry Pages: 282
Industry

QUALITY APQ Guide: Corrective APQ Guide: Corrective Published: November

MANAGEMENT Action & Preventive Action & Preventive 2020
Action (CAPA) System Action (CAPA) System Pages: 136

Guide: Cleaning
Cleaning Validation
Validation Lifecycle - Published: August 2020
Lifecycle - Applications,
Applications, Methods, & Pages: 236
Methods, & Controls
Controls

STERILE PRODUCTS Published: January 2021

PROCESSING (SPP) Maintenance Good Practice Guide:
Pages: 132
Maintenance 2nd Edition

Baseline Guide Vol 3:

Sterile-Product
Sterile Product Published: April 2018
Manufacturing Facilities
Manufacturing Facilities Pages: 244
(Third Edition)
3rd Edition

Good Practice Guide: Published: January 2021

Maintenance
Maintenance 2nd Edition Pages: 132
SUSTAINABLE
FACILITIES Published: December
Sustainability Handbook: Sustainability 2015
Pages: 200
Date: 25.09.2024

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