Content focuses on process equipment, the design of facilities, and utility systems that support the critical physical and chemical requirements of drug products, in addition to other aspects of the product specification. Topics include design and construction/installation, commissioning and qualification, operation and maintenance, controls, and automation.
PE Articles
Pharma 4.0 – Plug & Produce Architectural Principles
A set of principles to be considered in the journey to adopting and deploying an architecture…
Product
Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
Published: December 2024 Pages: 122 Table of Contents Special Pricing for Emerging Economies This…
iSpeak Blog
2024 FOYA Banquet Recap: Celebrating Excellence and Tips for Submitting to the 2025 Facility of the Year Awards
The evening of Sunday, 13 October, many members of the ISPE community gathered in Orlando, Florida…
PE Articles
Greenfield manufacturing in life sciences
In this point of view, Life Sciences greenfield builds, Capgemini’s life sciences manufacturing…
iSpeak Blog
Process Considerations When Designing mAbs Production Facilities
Designing a monoclonal antibody (mAbs) production facility presents a series of unique challenges…
iSpeak Blog
Global Adoption Status and Implementation of ICH Guidelines Q12, Q2(R2), and Q14
At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon…
iSpeak Blog
FDA CDER Associate Director Speaks About Regulatory Reliance and Agility
Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug…
iSpeak Blog
A Message from the 2025 ISPE Aseptic Conference Chair
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has…
iSpeak Blog
Overcoming Fear of the Engineer-Procure-Construct (EPC) Model to Recognize Project Execution Benefits
In an increasingly complex world, where the reliable delivery of power from point A to point B often…
iSpeak Blog
Beyond Automation: The Human Touch in Industry 5.0
The future of manufacturing is not a battle between humans and machines. It is a collaboration that…
iSpeak Blog
Updated ISPE HVAC Guide Provides Support for Professionals at All Levels of Experience
In September, ISPE released the second edition of their Good Practice Guide on Heating, Ventilation…
PE Articles
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
Guidance Documents
Advanced Manufacturing (3)
Advanced Therapy Medicinal Products (1)
Biotechnology (3)
Commissioning & Qualification (5)
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Decommissioning Pharma Equipment & Facilities
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Compounding (2)
Containment (4)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Asset Management
Critical Utilities (7)
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: C&Q of Pharma Water & Steam Systems 2nd Edition
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Critical Utilities GMP Compliance
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Data Integrity (2)
Good Manufacturing Practice (1)
Manufacturing Operations (9)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Guide: ATMPs - Allogeneic Cell Therapy
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms
- Guide: ATMPs - Autologous Cell Therapy
- GAMP Good Practice Guide: Manufacturing Execution Systems
- Good Practice Guide: Maintenance 2nd Edition
- Good Practice Guide: Equipment Reliability
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
Microbiological & Viral Contamination Control (15)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Process Gases 2nd Edition
- Baseline Guide Vol 2: Oral Solid Dosage Forms 3rd Edition
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls
- Good Practice Guide: Quality Lab Facilities
- Good Practice Guide: Membrane-Based WFI Systems
- Good Practice Guide: Containment for Potent Compounds
- D/A/CH Affiliate: WFI Handbook (English Translation)
- Good Practice Guide: HVAC & Process Equipment Air Filters
- Good Practice Guide: Asset Management
- Baseline Guide Vol 3: Sterile Product Manufacturing Facilities 3rd Edition
- Japan Affiliate: Pest Control Manual (English Translation)
- Good Practice Guide: Sampling Pharma Water, Steam, & Process Gases
Oral Solid Dosage (2)
Packaging (2)
Pharma 4.0™ (1)
Quality Assurance (1)
Quality Control (2)
Quality by Design (2)
Regulatory (5)
- Good Practice Guide: Ozone Sanitization of Pharm Water Storage & Distribution Systems 2nd Edition
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Baseline Guide Vol 4: Water & Steam Systems 3rd Edition
- Good Practice Guide: Critical Utilities GMP Compliance
- Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
Single Use Technologies & Disposables (1)
Sterile Products (2)
Supply Chain Management (2)
Sustainability (1)
Sustainable Facilities, HVAC, & Controlled Environments (6)
- Good Practice Guide: SMEPAC - Standardized Methodology for the Evaluation of Pharma Airborne Particle Emissions from Containment Systems 3rd Edition
- Good Practice Guide: Heating, Ventilation, & Air Conditioning (Second Edition)
- Good Practice Guide: Cold Chain Management
- Good Practice Guide: Containment for Potent Compounds
- Good Practice Guide: Controlled Temperature Chambers 2nd Edition
- Good Practice Guide: HVAC & Process Equipment Air Filters
Community Discussions
Community Discussions
Dec 27, 2024
Dec 20, 2024
Dec 19, 2024
GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Dec 11, 2024
Data Integrity
Dec 04, 2024
Good Manufacturing Practice
White Papers
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
July / August 2023
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
May / June 2023
North Carolina’s Research Triangle is the largest of its kind in the US. Thanks to years of effort…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
Pharmaceutical Engineering Magazine Articles
Net-Zero Manufacturing Facilities: Obstacles and Benefits
The decision to pursue net-zero facility design in manufacturing is complicated. There are…
FOYA Projects Embrace Innovative Sustainability Solutions
Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects…
Setting Net-Zero Targets: Tangible Benefits of Sustainability
Many organizations are on the right path to sustainability, but more can still be done— especially…
Decarbonizing Pharmaceutical Manufacturing Facilities
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This…
Embracing the Unknown: QRM Strategies for Cell and Gene Therapies Facilities
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the…
Data Analysis of Contamination Control Strategies for Production
On 25 August 2023, the long-awaited revision to Annex 1 became effective, introducing significant…
Room Differential Pressures in Facility Design: Fundamentals
The expectations for room differential pressures to maintain air quality in pharmaceutical facility…
Experts Create Examples of C&Q Deliverables
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and…
A Guide to Unique Identification of Glass Primary Containers
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in…
New Guide for Compounding Pharmacies
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good…
Acceptable Discoloration Levels on Pharmaceutical Weld Beads
Welds used in biopharmaceutical manufacturing must meet critical criteria to maintain a defined…
Automation Supports ESG Goals for Pharma Facility Conversion
Implementing advanced automation technologies is a strategic move that can amplify the positive…
Professional Development Training
GMP Fundamentals: Eleven-Part Bundle Series
Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for…
Biopharmaceuticals: Webinar C> e ATMP
Biopharmaceuticals: Webinar de treinamento em C> e ATMP Visão geral Este webinar é uma gravação do novo curso de instrutor que é um curso de nível avançado sobre therapies C e Gene T (C>) e Medicamentos de Terapia Avançada (ATMP). O curso também fornece umavisão geral dos componentes mais comuns e estabelecidos que são aproveitados em produtos C> (por exemplo, plasmídeos, mRNA, nanopartículas lipídicas, vetores virais), cobrindo terminologia, processos de fabricação e subsequente caracterização analítica de os componentes fabricados e os produtos terapêuticos. As plataformas de células T…
Produtos Biofarmacêuticos: Aspectos CMC
Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Treinamento sobre Aspectos CMC Visão geral Este webinar é uma gravação do novo curso de instrutor, que é um curso de nível avançado sobre aspectos de Química, Fabricação e Controle (CMC) do desenvolvimento biofarmacêutico. O objetivo deste curso é fornecer uma compreensão avançada dos aspectos CMC de biofármacos desde o desenvolvimento até a comercialização. O que você vai aprender Visão geral do desenvolvimento biofarmacêutico Qualidade por Design (Quality by Design – QbD) Linhagem Celular e Desenvolvimento a Montante (Upstream)…
GMP Fundamentals: Packaging & Labeling Control
In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of packaging and labeling operations, including production and inspection processes, documentation, and record-keeping. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average, the time required for completion…
GMP Fundamentals: Buildings and Facilities
A “GMP Facility” is a building that is used in the production of pharmaceutical and medical device products. The proper design, layout, function and control of such facilities is essential in the manufacture of pure, safe and effective pharmaceutical products. In this course, learners will focus on understanding the building layout, safety, cleanroom conditions, as well as facility sanitation and ventilation of both production and support areas. In this On Demand course (part 4 of 11), you will learn the elements of GMP Buildings & Facilities, as required by regulation. Interactive Course…
