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

INTERPHEX 2012 Coverage

Follow all the action from this year's INTERPHEX Show in New York. Read more »

The Pulse of Pharmaceutical Manufacturing

The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism. Read more »

Instrument Tolerances: Manufacturer vs. Process

Using the instrument maker’s tolerance, there is often a higher risk of an “Out of Tolerance” appearing on a calibration certificate; this costs money. Read more »

Think you're a compliance expert? Receive a perfect score on our monthly quiz and you'll become a Compliance Champion and be entered into a monthly drawing for a custom coffee mug. Good luck! Read more »

Funny Pharm: Write the Cartoon Caption & Win

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

White Papers

Implementing 5S Workplace Organization Methodology Programs In Manufacturing Facilities Many manufacturing facilities have opted to follow the path towards a “5S” workplace organizational and housekeeping methodology as part of continuous improvement or lean manufacturing processes.
Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
Three Steps to Leveraging Expertise in Global Pharmaceutical Production
Reducing Airborne Contaminants with Polymeric Floor Coverings
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Events Calendar

Keep track of upcoming events relevant to the pharmaceutical manufacturing industry. Visit our events calendar.

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Product Center

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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

From the Editor: Brush Up on Statistics (Or Face the Consequences)Are you using statistics to support the status quo, or to get to true root cause?
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PharmaView: Carrots, Sticks, and CEOsSalary does not dictate motivation and performance.
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Digital Insights: Pinterest for Pharma?Does Pharma have a place on Pinterest?
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Therapeutic Dose: Reforesting InnovationTrade show consolidation can be a good thing, at least when it gives smaller innovator companies room to grow.
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Aseptic Processing

View: Articles (32) Whitepapers (8) Industrynews (4) Products (97)

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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The Executive Guide to Contract and Chargeback Management: How Pharmaceutical Manufacturers Smartly Automate to Strengthen Profitability

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cGMPs and Compliance

View: Articles (157) Whitepapers (44) Industrynews (83) Products (30)

Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring: Wired, Wireless and Standalone Monitoring Systems

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Contract Manufacturing

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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

Webcast: Facilities of the Future, Today Join us for a review and moderated discussion of the issues and technologies driving new pharmaceutical manufacturing facility design and construction, both in the U.S. and in growing Asian markets. Among the questions, in the U.S. are: where are the facilities being built and how will that affect industry employment trends? How are they being designed?
Webcast: Supply Chain Security at Pfizer: Threats, Strategies, and Successes Recent high-profile product recalls and counterfeiting cases have drawn attention to the need for drug manufacturers to work across the entire supply chain to ensure product safety and quality. Join Brian Johnson, Pfizer Senior Director of Supply Chain Security, and consultant Russ Somma, in a webcast discussion of best practices for ensuring supply chain security.
Webcast: Turning Biopharm Data into Knowledge: A Patient-Centered Approach Biopharmaceutical manufacturing is often described as "data rich, but information poor." Focusing on essential data, and making it accessible to those who need it, in the format most useful to them, is the key to improving product quality, ensuring compliance and reducing time to market. What do manufacturers need to do, and how are forward-thinking companies tackling this problem? Join us for a program exploring issues, presenting today's best practices and exploring future solutions.

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