Pharmaceutical Industry | Processing & Engineering: Knowledge, News and Analysis

Coming of Age

It’s been 10 years since the FDA released Pharmaceutical GMPs for the 21st Century, but it’s likely the next 10 that will shape the industry for decades after Read more »

Focus on Efficiency

Single-use, analytical methods and downstream processing at the forefront. Read more »

Powder Flow: Identifying Powder’s Critical Quality Attributes & Relationship to Process Behavior

Powders are highly complex variable materials and are used in the manufacture of over 80% of products currently on the market. Flow properties relate to numerous processes so powder behaviour will influence all sorts of key quality attributes of the finished product. Read more »

Ins & Outs of Tech Transfer

Best practices for one of oursourced manufacturing's tougher challenges Read more »

Funny Pharm: You Write the Caption & Win: May 2013

"Funny Pharm," features drawings by award-winning cartoonist Jerry King. Submit your caption and win Read more »

White Papers

PharmaManufacuring eBook: Holistic QbD Since FDA introduced the term to the pharmaceutical industry in 2005, the concept of pharmaceutical quality by design (pharma QbD), a framework for building quality into pharmaceuticals during drug development has been slowly gaining ground. Discrete industries are no strangers to QbD. Now, however, some vendors to the pharmaceutical industries are applying pharma QbD principles to develop their pharmaceutical industry products. This e-book offers general resources in the area of QbD, and discusses how West Pharmaceuticals has been bringing a QbD approach to its packaging components.
Application Brief: Filtration Processes Applied in Therapeutic Monoclonal Antibody Production
Pharmaceutical & Medical Devices Industry Applications
Single-Use Depth-Filtration System
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Backpack Reporting

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Audio Update

Focus on Pharma: Episode 24: The Facility of Tomorrow: Biopharma Leads the Industry Biopharmaceutical manufacturers are reducing risk and cost by using modular construction, disposable process equipment, contained equipment and other innovations. Will they change the industry's approach to plant design and engineering?
Focus on Pharma: Faster Knowledge and Technology Transfer Using Video Transferability of experimental methods is a problem for industrial and academic labs alike, wasting millions of dollars each year. The Journal of Visualized Experiments (JoVE) uses video to help transfer the knowledge required to carry out lab experiments successfully. Co-founder Moshe Pritsker discusses its business model, industry issues and how the journal works.
Taking the Emotion Out of Pharma Outsourcing: John Gray Discusses Recent Research into Quality Risks Offshore Outsourcing and offshoring are touchy subjects for any community anxious about losing potential industry and jobs. A study in November's issue of the Journal of Operations Management suggests that quality risks increase when operations are moved offshore, but emphasizes the fact that this is a knowledge management problem. Lead author, Professor John Gray of Ohio State University's Fisher College of Business, discusses the study, industry reaction, misunderstandings and upcoming research on this important, but difficult, topic.
Focus on Pharma Episode 20: FDA and USP Collaborate to Update Standards for Over-the-Counter Medications A September workshop sponsored by FDA and USP will examine progress in modernizing analytical methods and test procedures, to help prevent adulterated over-the-counter medications from reaching the public. Impurities testing and material identification will be critical. Both Agencies summarized recent progress in these efforts at a July science advisory board meeting.
Focus on Pharma: FDA's Friedman Urges Better Supplier Oversight and Investment in Quality; Any Questions? Call Me, says FDA's Rothman Understaffing quality operations, failing to oversee suppliers and contractors, and blaming problems on mid-level QC and manufacturing managers, is not the answer. At a summer conference on GMP's, FDA's Rick Friedman and colleagues Barry Rothman and Steven Wolfgang, discussed the roots of current supply shortages, and emphasized the need for proactive communication with the Agency and its district offices. They also responded to criticism on the way the Agency's handling inspections.
Focus on Pharma Episode 18: New Blueprints for Pharmaceutical Quality by Design Critics have questioned industry’s commitment to QbD, but a recent conference sponsored by NIPTE was well attended by industry, and presented an important new case study. Editor in Chief Agnes Shanley reviews the conference and NIPTE’s Prabir Basu shares his views.
Podcast: Lean Labor: Applying Discipline to the Pharma Workforce Gregg Gordon’s new book, Lean Labor, looks at how Lean and continuous improvement efforts must go beyond manufacturing, materials, and machines and also address worker needs and productivity.
Podcast: TruProcess: Next-Generation Near-Infrared (NIR) Spectrometer for Pharmaceutical Processing Duane Sword, Sr. Director, Thermo Scientific discusses the capabilities and technical attributes of TruProcess, an advanced NIR spectrometer for real-time blend analysis, drying and other process analytical technology (PAT) applications.

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From the Editors

We Are All Bostonians NowPharmaceutical industry among the tragedy’s first responders
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PharmaView: Single-Use Standards: What’s the Rush?Can standardization and innovation coexist?
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Gaming: Good Medicine?According to a recent keynote address by Jane McGonigal, gaming has a huge growth potential in the pharmaceutical industry
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Where Is the Outrage and the Shame? Do Americans really care more about see-through yoga pants than defective pills and implants?
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Aseptic Processing

View: Articles (34) Whitepapers (8) Industrynews (4) Products (98)

Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers

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Automation & Control

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Articles

Biomanufacturing Morphs

Looking for Supply Chain Answers in 2011

Biotech Production: Planning, Scheduling and Throughput Analysis with a Combined Theory of Constraints, Lean and Simulation Approach

PDA 2010: Stopper Sensibility

Bringing More Science to Tableting

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Webcast Library

On-Demand: Ensuring Pharmaceutical Product & Process Quality with Spectrometric Methods More than 20 on-demand webcast presentations from industry experts and leading solutions providers. NIR, Raman and Particle Characterization technologies and applications that are improving pharmaceutical product and process quality.

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