International Society for Pharmaceutical Engineering (ISPE)

Provides good practice approaches which promote the successful integration of GxP with relevant project management activities to ensure compliance risk is managed effectively.

Establishes a baseline for the design of Quality Laboratory Facilities supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications.

The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and processes under GEP that support and enable the design, delivery, and operation of engineered systems across their complete lifecycle.

Guide on establishing and managing engineering standards within pharmaceutical organizations.

ISPE Good Practice Guide focusing on operations management within the pharmaceutical industry.

Guides the transfer of manufacturing processes and analytical procedures between facilities or laboratories during pharmaceutical development and commercialization.

The updated ISPE Good Practice Guide: Sampling for Pharmaceutical Water, Steam, and Process Gases (Second Edition) explains how improper sampling can lead to misleading results, unnecessary investigations, or missed quality issues that may ultimately affect patient safety or delay product release.

Reviews unit operations in continuous manufacturing, aims to establish minimum equipment requirements, and considers changes in physical and automation requirements.

Guide on ensuring GMP compliance for critical utility systems in pharmaceutical facilities.

Guide detailing knowledge management methodologies for the pharmaceutical sector.

The shift in process validation from a one-time event to the product lifecycle approach expected by most global markets has led to significant changes in validation practices.

Good practice guide for heating, ventilation, and air conditioning systems in pharmaceutical facilities.

Provides a comprehensive framework and set of good practices to support holistic digital enablement in Pharma 4.0.

Provides tools and strategies for Cold Chain Management to help develop, establish, document, and improve industry good practice for products requiring controlled cold conditions.

ISPE Good Practice Guide focusing on the development of investigational therapeutic biological products.

Delivers practical, expert-driven insights into the selection and qualification of equipment for cellular therapy manufacturing.

Guide focusing on the design and operation of membrane-based water for injection (WFI) systems.

Describes processes for applying a Unique Identifier (UID) on each primary parenteral container and outlines best practices for developing, implementing, and managing a traceability project.

Good practice guide focused on clinical supply systems and investigational products.

Good practice guide detailing Interactive Response Technology (IRT) in clinical trials.

Outlines best practices for implementing single-use technology into a process to minimize surprises, offering flexibility and reducing contamination risks.

Guide on engineering controls and containment strategies for handling potent compounds.

Guide providing best practices for effective maintenance management in pharmaceutical facilities.

Guide outlining best practices for the design and operation of packaging, labeling, and warehousing facilities.

Addresses pharmaceutical water and steam systems commissioning and qualification (C&Q) by science and risk-based as well as traditional approaches.

Good practice guide addressing Investigational Medicinal Product (IMP) reverse logistics.

Guide on selection, testing, and maintenance of air filters in HVAC and process equipment.

Guide on commissioning, qualification, and maintenance of controlled temperature chambers.

Covers regulatory considerations, lifecycle management, and integration of future technologies for continuous biomanufacturing (CBM).

Considers how increased adoption of Digital Validation Tools (DVTs) in the life sciences industry can support data integrity, operational efficiency, and regulatory compliance.

Provides principles and standardized methodologies for evaluating the containment capability of equipment used in the pharmaceutical industry under specific, defined conditions.

Guide focusing on improving equipment reliability and uptime in pharmaceutical manufacturing operations.

Guide detailing standard methodologies for safely decommissioning pharmaceutical equipment and facilities.

Guide on maintaining and managing physical assets effectively within pharmaceutical facilities.

Good practice guide on applying ozone sanitization methods to pharmaceutical water systems.

Good practice guide detailing the harmonization of definitions and use of non-investigational medicinal products (NIMPs).

A workshop-driven course defining Good Engineering Practice (GEP) to support and enable the design, delivery, and operation of engineered systems in the pharmaceutical industry.

Considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to GxP.

Introductory training course covering good manufacturing practices (GMPs) for the pharmaceutical industry.

The ISPE Baseline Guide: Commissioning and Qualification (Second Edition) provides practical guidance on the implementation of a science and risk-based approach for the Commissioning and Qualification of pharmaceutical manufacturing facilities, systems, utilities, and equipment.

This revised Guide builds on the original principles of ISPE's Baseline Guide Volume 1, Active Pharmaceutical Ingredients, incorporating new regulations and guidance such as ICH Q7, ICH Q9, GAMP 4, and 21 CFR Part 11.

The ISPE Baseline Guide: Oral Solid Dosage Forms (Third Edition) considers current and new technologies such as Process Analytical Technology and continuous manufacturing, addressing containment, cross-contamination, and facility design.

Baseline Guide Volume 6: Biopharmaceutical Manufacturing Facilities, available as a digital download.

Aims to assist with the design, construction, operation, and lifecycle management of new and existing water and steam systems in compliance with GMPs.

Covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities using modern technologies.

Japanese translation of the ISPE Baseline Guide: Commissioning and Qualification (Second Edition).

The Guide covers all areas of transformation including the benefits of a holistic control strategy, opportunities opened by digital transformation in quality management, and foundational processes for interconnected plant architecture.

This second edition of the ISPE Baseline Guide on Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) offers a structured approach for managing cross contamination risk in pharmaceutical manufacturing, aligned with ICH Q9 quality risk management principles.

Presents concepts that reflect how changes in technologies affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.

An online live training course designed to develop the concept of the project lifecycle from initiation through to delivery of business benefits for facility projects within the regulated pharmaceutical industry.

Provides tools on how to implement a sustainable approach to a risk-based C&Q program and integrate into existing quality systems.

Fundamental online course introducing participants to regulatory requirements for computerized systems in the pharmaceutical industry and implementing the GAMP 5 Guide.

This third edition delivers a powerful, forward-looking update designed to help organizations confidently navigate the rapidly evolving manufacturing and technology landscape, aligned with ISPE GAMP 5.

Guide detailing compliance requirements for computerized systems utilized in laboratory settings.

Guidance on maintaining compliance during the operational lifecycle of GxP computerized systems.

Guidance on qualifying and managing IT infrastructure supporting GxP systems.

GAMP guide for the specification, validation, and management of Manufacturing Execution Systems (MES).

Guide exploring strategies to foster innovation within regulated computerized systems without compromising compliance.

Guidance on the development, validation, and operation of mobile applications used in GxP environments.

Good practice guide providing practical guidance on computerized good clinical practice (GCP) systems and data integrity.

Guidance document establishing principles for records and data integrity within regulated pharmaceutical environments.

This training course covers data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems.

Foundational training course on GAMP principles for validation of automated systems in pharmaceutical manufacturing.

Designed to provide a clear understanding of regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses.

An online live training course focusing on the practical application of the lifecycle approach to all stages of pharmaceutical process validation.

Regulation handbook covering 21 CFR Parts 210 (General) & 211 (Finished Pharmaceuticals) Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs.

Guidance for Industry Q10 Pharmaceutical Quality System published by ISPE, used in association with several training courses.

Guidance for Industry on Pharmaceutical Development Q8(R2) provided by the U.S. Department of Health and Human Services, Food and Drug Administration, and distributed by ISPE.

Regulation handbook covering 21 CFR Part 11 electronic records and electronic signatures, used with ISPE training courses.

Regulation handbook covering dietary supplements cGMP requirements under 21 CFR Part 111.

Regulation handbook covering medical device quality systems regulation under 21 CFR Part 820.

Online course introducing participants to the development of biopharmaceuticals, highlighting differences between small molecules and biomolecules.

Introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product.

An advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development from development to commercialization.

Active Pharmaceutical Quality (APQ) guide addressing process performance and product quality monitoring systems.

APQ guide outlining management responsibilities and review processes.

Systematic approach for organizations to evaluate and improve change management systems.

Systematic framework for evaluating and improving CAPA systems in pharmaceutical operations.

APQ program guide focused on fostering cultural excellence.

Practical guidance on change management implementation based on ICH guidelines.

Guidance on monitoring process performance and product quality aligned with ICH Q8/Q9/Q10.

Product Quality Lifecycle Implementation (PQLI) guide explaining concepts and principles of product realization using Quality by Design (QbD).

Product Quality Lifecycle Implementation (PQLI) guide providing illustrative examples for product realization using Quality by Design (QbD).

This training course identifies criteria for successful technology transfer and provides how-to examples.

Training course detailing the process of transferring technology between R&D and manufacturing sites.

This ISPE Guide focuses primarily on manufacturing facility development and design for autologous cell therapies for parenteral use, providing an overview of critical aspects of ATMP facility design and current process/facility attribute alignment.

Guidance document covering validation methods and controls for advanced therapy medicinal products throughout the cell and gene therapy product lifecycle.

Guide covering allogeneic cell therapy manufacturing and facility considerations.

ISPE guide addressing advanced therapy medicinal products, specifically recombinant adeno-associated virus (rAAV) comparability and lifecycle management.

Standard operating procedure template for responding to and investigating environmental monitoring excursions.

Standard operating procedure template for corrective and preventive action (CAPA) programs.

Standard operating procedure template addressing product quality complaints in pharmaceutical manufacturing.

Standard operating procedure template for investigating out-of-specification results in laboratory and manufacturing environments.

Standard operating procedure template for managing product recalls within a quality management system.

A classroom training course providing an understanding of key requirements and GMPs for sterile manufacturing facilities using the ISPE Baseline Guide and FDA guidance.

Online training focusing on clean-in-place design integration and cleaning chemical selection vital for pharmaceutical manufacturing processes.

An online live training course focusing on aseptic processing and quality management around pharmaceutical technology, aligned with the EC GMP Guide Annex 1.

This course is focused on how to be compliant in the design, operation and qualification of critical utilities and how to prove it.

Comprehensive training course focused on critical utilities within pharmaceutical facilities.

Online course providing an opportunity to explore requirements for airflow pattern visualization with video examples of actual results.

Detailed training course covering pharmaceutical water generation systems, design, and operation.

This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection.

Explains and applies the science and risk-based approach to integrated lifecycle Commissioning and Qualification using QRM.

Provides a fundamental overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals.

Specialized training course covering HVAC system design, operation, and maintenance in pharmaceutical facilities.

Covers the risk-based approach to cleaning development and verification, risk analysis, procedures, and evaluation tools.

An interactive training course explaining and applying the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment, and facilities.

Advanced, hands-on training utilizing commercial scale operational aspects at BTEC to address current, real world manufacturing challenges.

Practical training course focusing on aseptic processing techniques and compliance with Annex 1 guidelines.

Good practice guide outlining fundamental concepts for maintaining data integrity in manufacturing and laboratory systems.

This course covers the principles of design and operation of water systems used directly in pharmaceutical manufacturing and laboratory applications.

A 2-day training course introducing requirements and internationally recognized methods for AI-enabled computerized systems.

Provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products.

Hands-on training course on the controlled production of drug substances and products.

Provides a comprehensive understanding of biotech manufacturing processes and underlying principles of proteins and cells.

Provides a comprehensive understanding of biotech manufacturing processes and explores underlying principles of proteins and cells.

This course provides a comprehensive understanding of biotech manufacturing processes, exploring the underlying principles of proteins and cells.

An advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP) covering components, manufacturing processes, and analytical characterization.

The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products.

Practical training course covering commissioning, qualification, process validation, and advanced therapy medicinal products.

Training guide providing an introduction to US clinical trial materials regulations and requirements.

Training course covering project management methodologies specific to pharmaceutical facility construction and updates.

Instructor-led virtual course covering project management principles specifically tailored for the regulated pharmaceutical industry.

Online training session covering a case study of the selection, installation, and operation of a flexible design and production platform for clinical vaccine production.

Guide detailing facility design and operations for oligonucleotide and peptide manufacturing.

Readiness report bundle providing insights and benchmarks for pharmaceutical manufacturing compliance.

Guidance document covering principles, good manufacturing practices, and case studies for 503B compounding pharmacies.

A fundamental course ideal for professionals new to the biotechnology industry or entering new work assignments encompassing biotechnology operations.

Explains how to apply revised ICH Q9(R1) principles and tools to support more effective QRM and a stronger Pharmaceutical Quality System.

Guide addressing regulatory and facility requirements for 503A compounding pharmacies.

Online course exploring pros and cons of cloud-based computing, differences from company-owned servers, data concerns, cyber security, and blockchain.

Guide providing strategies for environmental sustainability in pharmaceutical facilities and operations.

Comprehensive guide covering clinical materials for pharmaceutical manufacturing and clinical trials.

Tool and model for assessing and preventing drug shortages in pharmaceutical supply chains.

Training webinar recording covering advanced-level concepts on Cell and Gene Therapies (C&GT) and Advanced Therapy Medicinal Products (ATMP).

Provides an overview of the C&Q delivery process along with implementation recommendations for the application of Quality Risk Management supporting qualification.

Manual translated into English focusing on pest control procedures in pharmaceutical manufacturing environments.

Report outlining the six key dimensions of cultural excellence in the pharmaceutical industry.