Content focuses on feature key components and the financial impact of supply and distribution chains. Topics focus on the systems required to control and automate the receipt, storage, and dispensation of raw and packaging materials and the storage and distribution of finished products. Other topics could include materials management, operational economics, and warehouse and distribution management.
iSpeak Blog
Women in Pharma® Member Spotlight on Miriam Kremer-van der Kamp
Miriam Kremer-van der Kamp is the Business Developer at VILS Switzerland GmbH and an active ISPE…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
FDA on AI in Pharmaceutical Manufacturing
At the 2024 ISPE Biotechnology Conference , held in Boston, Massachusetts, USA, in June, Sharmista…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
PE Articles
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
iSpeak Blog
2023 Roger F. Sherwood Article of the Year Award Finalists Announced
Pharmaceutical Engineering® (PE) is delighted to announce the finalists for the 2023 Roger F…
PE Articles
2024 State of Validation Report
Unlock the latest insights and trends in validation practices with the 2024 State of Validation…
PE Articles
The CDMO Handbook: Overcoming Industry Challenges With Digital Validation
Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing…
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…
PE Articles
Alcohols for Use as an Antimicrobial Agent
In healthcare and pharmaceutical settings, alcohol refers to two water-soluable chemical compounds…
PE Articles
Transforming Pharma Development: Digitalization and QbD
Nowadays, integrating data and digital information, in general, has emerged as a topmost concern for…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Investigational Products (1)
Packaging (1)
Project Management (1)
Regulatory (1)
Single Use Technologies & Disposables (1)
Supply Chain Management (6)
Sustainable Facilities, HVAC, & Controlled Environments (1)
Community Discussions
Community Discussions
Sep 07, 2024
Quality
Aug 29, 2024
Data Integrity
Aug 27, 2024
Validation
Aug 20, 2024
Aug 20, 2024
Critical Utilities
Quality Control
Aug 20, 2024
Regulatory
Regulatory
iSpeak Blog Posts
ISPE in the News
Latest
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I came at language standing on my head, turning words inside out in search of meaning, making a mess of it sometimes, but seeing truth from a very different viewpoint.
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Countdown Timer to Annual Meeting
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FDA on AI in Pharmaceutical Manufacturing
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Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
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Digital twins have potential in drug development
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Cannabis testing labs accused of inflating THC results
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Lonza microbial fermentation plant receives GMP license
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Scottish government supports Symbiosis GMP plant
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Novartis expands radioligand therapy capacity with 2 new plants
- Perfusion technologies enable process intensification
Pharmaceutical Engineering Magazine Articles
Digital Display Labeling in Clinical Supplies for Clinical Trials
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the…
ATMP-Focused Online Seminars Educate and Inspire
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements…
Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the…
Considerations for a Decentralized Manufacturing Paradigm
The biopharmaceutical industry must develop and implement innovative ways of working to be effective…
ISPE Briefs: ISPE Initiatives Provide Guidance on Medicines Supply
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages…
Regulatory Landscape for Raw Materials: CMC Considerations
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients…
Supplier Qualification Program for Key Raw Materials
With the publication of recent guidance, specifically the US FDA Quality Systems Approach to…
Drug Shortages: a 30,000 Ft View: Business Continuity Planning for Preventing Drug Shortages
As noted in the ISPE Drug Shortages Prevention Plan , International Society for Pharmaceutical…
Operational Risk Management in Global Supply Scenarios
The current regulatory framework in the pharmaceutical industry places pressure on marketing…
White Papers
March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
Videos
Professional Development Training
GMP Fundamentals: Holding & Distribution
In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to Online Learning
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