Pharmaceutical Product Lifecycle Management is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. Lifecycle Management forms the product information backbone for a company and its extended enterprise.
Video
The Use of Engineering Change Management (ECM)
Complimentary Learning Level: Basic Session Length: 1 hour Asset Life Cycle Management evolves in…
PE Articles
Real-Time Process Monitoring: Why Have It and How to Get It
Real-time process monitoring involves integrating physical sensors into production processes to…
iSpeak Blog
The Future of ATMPs: Insights, Opportunities, and Innovations at the 2024 ISPE Annual Meeting
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with…
Product
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
Published: July 2024 Pages: 258 Table of Contents Special Pricing for Emerging Economies Advances in…
Video
Connecting ATMP Discovery to Commercial: Improving Manufacturability
Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level…
Video
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
PE Articles
Evaluation of Impact of Statistical Tools on Process Performance Qualification (PPQ) Outcomes
This discussion paper uses segments of typical validation case studies (validation of key attributes…
PE Articles
Stage 2 Process Validation: Process Performance Qualification Batches
The purpose of this paper is to stimulate further discussion and suggest potential practical…
PE Articles
Implementing Lifecycle Validation Practices at Contract Manufacturing Organizations
This paper discusses the nuances of lifecycle validation implementation at contract manufacturing…
PE Articles
Determining Number of Process Performance Qualification Batches Using Statistical Tools
This is the second discussion paper written by the ISPE Process Validation (PV) Team on the topic of…
PE Articles
Process Validation Lifecycle Implementation for Existing (“Legacy”) Products
This Discussion Paper examines some of the topics and challenges related to the implementation of…
PE Articles
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
Guidance Documents
Advanced Manufacturing (1)
Biotechnology (2)
Knowledge Management (1)
Lifecycle Management (6)
- GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Guide: Biopharmaceutical Process Development & Manufacturing
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Manufacturing Operations (1)
Process Analytical Technology (3)
Quality by Design (2)
Community Discussions
Community Discussions
Nov 20, 2024
Regulatory
Regulatory
Nov 18, 2024
Regulatory
Regulatory
Nov 17, 2024
Sustainable Facilities, HVAC, & Controlled Environments
Manufacturing Operations
Nov 17, 2024
Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Nov 04, 2024
Regulatory
Supply Chain
Active Pharmaceutical Ingredients
Good Manufacturing Practice
Nov 03, 2024
Women in Pharma®
Pharmaceutical Engineering Magazine Articles
PE Articles
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
PE Articles
Risk- And Science-Based Media and Buffer Mixing Validations
The validation of media and buffer mixing is a continuing area of resource constraint in the…
PE Articles
Leveraging GAMP® 5 Second Edition for Medical Devices
This article provides a brief introduction into the standards and regulations for medical devices…
PE Articles
Life-Cycle Approach to Cleaning Topical Drug Products
Topical drug products and cosmetics are often manufactured in the same facility under a unified…
PE Articles
Streamlining Postapproval Submissions Using ICH Q12 & SCDM
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but…
PE Articles
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process…
PE Articles
Viral Vector Platforms: Intersection of Facility and Program
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
PE Articles
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and…
PE Articles
PQLI®: Advancing Innovation & Regulation
A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For…
PE Articles
A Vision for ICH Q12: Current Experience, Future Perspectives
Management of global postapproval chemistry, manufacturing, and controls (CMC) changes is a growing…
PE Articles
Navigating the Life Cycle for Cell & Gene Therapies
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing…
PE Articles
Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
This second of a two-part series explores digital transformation and digitalization in the…
Webinars
White Papers
Lifecycle Approach to Biotech Process Validation
This discussion paper proposes ideas for answering the questions about the application of the…
Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…
Special Initiative Documents
Videos
iSpeak Blog Posts
Professional Development Training
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
Quality Management Systems Training Course
Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.
Quality Risk Management (QRM) Workshop Training Course
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.