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.
PE Articles
Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and…
PE Articles
Volunteer Profile: Massimiliano Cesarini, Sterile Products Processing Community of Practice Chair
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his…
PE Articles
Meet the ISPE Staff: Xuandai Hoang
In each issue of Pharmaceutical Engineering ®, we introduce a member of the ISPE staff who provides…
PE Articles
ISPE Advocates for Members with European Medicines Agency
ISPE is an officially recognized stakeholder of the European Medicines Agency (EMA), the agency…
PE Articles
ISPE’s ICH Q12 Team Trains Singapore’s HSA on Regulatory Guideline
ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course…
iSpeak Blog
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Desiccant Dehumidification Future-Proofs Pharma Production
Environmental control plays a critical role in pharmaceutical manufacturing, particularly when it…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development
Pharmaceutical companies can no longer rely on traditional drug development methods to keep pace…
PE Articles
ABM Clean Room Solutions for Life Science Companies
ABM uses advanced technology and precise tracking to ensure cleanroom compliance, prevent…
PE Articles
Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and…
PE Articles
Volunteer Profile: Massimiliano Cesarini, Sterile Products Processing Community of Practice Chair
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his…
PE Articles
Meet the ISPE Staff: Xuandai Hoang
In each issue of Pharmaceutical Engineering ®, we introduce a member of the ISPE staff who provides…
PE Articles
ISPE Advocates for Members with European Medicines Agency
ISPE is an officially recognized stakeholder of the European Medicines Agency (EMA), the agency…
PE Articles
ISPE’s ICH Q12 Team Trains Singapore’s HSA on Regulatory Guideline
ISPE’s Q12 Implementation Team continued its series of training events with a well-attended course…
iSpeak Blog
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence
A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting…
PE Articles
Presaturated Wipes: Simple and Powerful Contamination Control
Cleaning surfaces and equipment in controlled environments has historically involved a variety of…
PE Articles
Desiccant Dehumidification Future-Proofs Pharma Production
Environmental control plays a critical role in pharmaceutical manufacturing, particularly when it…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Integrating Digital Transformation and Quality by Design for Enhanced Pharmaceutical Development
Pharmaceutical companies can no longer rely on traditional drug development methods to keep pace…
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Navigating the Horizon: ISPE’s Vision for Tomorrow
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ISPE Academy: GMP Refresher Certificate Program
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Startup Raises $5.5M for Precision Glycans
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EMA Proposes Updates to Guidance for Cell-, Gene-, Tissue-Based Therapies
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US FDA Issues Draft Guidance for Color Additives in Drugs
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Dawah Pharma Partners with Egypt for Supplements, Pharma Products Production
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Made Scientific Expands Cell Therapy Manufacturing Space
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Fujifilm's Tilburg Site Goes Greener with e-Boiler
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Automating Bioprocesses Without Sacrificing Flexibility
- ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data - Good eClinical Practice
Pharmaceutical Engineering Magazine Articles
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…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
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…
Single-Use Technology Waste in Manufacturing Operations
Single-use products used in the production of biologics provide flexibility that was unimaginable a…
Plastic Process Waste in Biopharmaceutical Manufacturing
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical…
Global Convergence Opportunities
The regulation of drug shortage prevention has rapidly changed over the past several years due to…
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…
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March / April 2023
As the pharmaceutical industry faces ever-changing global challenges and market forces, it must…
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