Focus on Pharma Podcast: Pharma Professional and Job Seeker Michelle Alton Cuts Through the Career Advice Clutter
Pharma professional Michelle Alton cuts through the conflicting career advice with tips on resume development, networking and a realistic, from-the-trenches view. Read more »
FDA Transparency Initiative: Opening FDA's 'Black Box'
This article by FDA's Special Assistant to the Principal Deputy Commissioner, Afia K. Asamoah, and published by FDLI, outlines opening the proverbial “black box” to help FDA more effectively implement its mission to promote and protect the public health. Read more »
Outsourced Manufacturing Strategies for Life Sciences: An Eli Lilly Case Study
This webcast will provide an overview of trends and challenges influencing life science companies’ outsourced manufacturing strategies. Read more »
Visit our Editor's Blog: On Pharma
We go behind consumer media headlines, beyond trade press boundaries, to offer candid analysis and commentary on issues affecting drug manufacturers. We cover the gamut, from fiscal to philosophical, from serious to silly. Read more »White Papers
- Risk Mismanagement: Where Pharma Companies Err In a survey of 65 life sciences execs, the Economist Intelligence Unit and KPMG found that risk management priorities are misguided. Companies fail to focus on embracing risk processes throughout their organizations, and most emphasize activities aimed at controlling regulatory risk rather than anticipating potentially greater threats.
- FDA Transparency Initiative: Opening FDA's 'Black Box'
- A Quality by Design Approach to Developing and Validating Dissolution Test Methods
- Enhancing Collaboration with the FDA Through MedWatch Plus
- View more white papers »
Events Calendar
Keep track of upcoming events relevant to the pharmaceutical manufacturing industry. Visit our events calendar.
Product Center
View all products »
Meissner Filtration Products: Fluid Path Assemblies
Thermo Fisher Scientific: New Platform for Benchtop Automation
Dionex: InGuard In-Line Sample Pretreatment Cartridges
Advantapure: BioClosures Systems Offer Secure Container Seals
Waters Corp.: ACQUITY UPLC H-Class System; HPLC Simplicity with UPLC Performance
Thermo Fisher Scientific: First Pre-cleaned Chromatography Vials
Wyatt Technology: Light Scattering Exclusion Chromatography Columns for Proteins
NewAge Industries: Polypropylene Tubing as Replacement for Costlier Fluoropolymer Tubing
Ask The Experts
- An unusual reclaim processFilled product is recovered from dose checks or improperly stoppered vials, is dumped into a holding tank, in a class 100,000 area, and once in the tank, it is pumped back to the main product holding tank. It is mixed with the product in the holding tank, refiltered and filled again during the course of the filling operations. Wouldn't this "reclaim process" be considered a reworking of the product? Unless this process was submitted along with the ANDA originally, and validated, it seems that this would not be following good cGMP practice for sterile filling operations. I don't think FDA or any other regulatory agency would find this to be an acceptable practice. What are your thoughts?
- Encouraging new syringe designs internationallyWhat’s being done to encourage new types of syringe designs internationally?
- OEE vs. TEEPWhat is more important, Overall Equipment Effectiveness or Total Effective Equipment Performance (TEEP)?
- World-class OEE for finished goods manufacturingWhat is world-class OEE for pharmaceutical finished goods manufacturing?
- Challenge of bringing new syringe technologies to marketThere are lots of new syringes and injection devices available to manufacturers. What’s keeping them from being brought to market?
- Choosing the right NIR instrument for the applicationWhich is the "best" near-infrared instrument on the market?
- ROI from NIR What would be the first application I should attempt with Near-Infrared?
- Validation of QBD/PAT activitiesMy query is regarding the impact of “QBD/PAT” on Development Procedures: 1. What “Stability Studies Data” are expected by the regulatory agencies for a product/process developed through PAT/QBD? 2. What kind of Validation activities are proposed for the "established co-relation" between the "process parameters and composition of formula" with Product Quality Parameters?
Career Center
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From the Editors
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From the Editor: Are You Myopic About Risk?Two years after the heparin disaster, the drug industry is still vulnerable to major quality, safety and security risks. -
PharmaView: The Great Swine Flu Conspiracy: The Plots ThickenWas it wrong to be prepared and a bit lucky? -
Digital Insights: Is Apple's iPad Our Future Together?The printed page has connected writers and readers for centuries. We've connected with you for nearly a decade now, and intend to do so for decades to come. But will Apple stand in the way? -
Therapeutic Dose: One Lot a Week?With improvements in instrumentation and analytics, continuous pharmaceutical processing has entered the realm of the possible.
Resource Centers
Aseptic Processing
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
A Business Case for Isolation Technology
Agalloco: Can We Break Down the Isolation Barriers?
Flexible Pharma: Puzzling Out the Plant of the Future
Webcast: Agility and the Pharmaceutical Facility of the Future
More articles »
White Papers
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers
Online UPLC Method for the Support of Cleaning Validation and the Routine Monitoring of Cleaning Procedures
Residual Solvents by HT3 Headspace in Reference to USP 467 with a Comparison of Static Versus Dynamic Headspace Analysis
More white papers »
Automation & Control
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
Roche Gets to the Core of MES
Taming the Scheduling Beast
Fabricating Tomorrow’s Pharma at the Nano Scale
PharmaView: Lilly’s Head Is in the Clouds: Virtualize Computing
More articles »
White Papers
Enhancing Collaboration with the FDA Through MedWatch Plus
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
The Executive Guide to Contract and Chargeback Management: How Pharmaceutical Manufacturers Smartly Automate to Strengthen Profitability
Complying With U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
More white papers »
cGMPs and Compliance
Articles
From Harmonization to Inspections: An FDA Update
From the Editor: Are You Myopic About Risk?
PharmaView: The Great Swine Flu Conspiracy: The Plots Thicken
Taking the Plunge to Harmonize Pharmaceutical Regulations
From the Editor: Ordinary Measures
More articles »
White Papers
FDA Transparency Initiative: Opening FDA's 'Black Box'
Enhancing Collaboration with the FDA Through MedWatch Plus
Accounting for Risk in Your Asset Management Strategy
Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Manufacturing
More white papers »
Contract Manufacturing
Articles
Master Quality Agreements: Prepare for the Unpredictable
Taking the Plunge to Harmonize Pharmaceutical Regulations
Webcast: Outsourced Manufacturing Strategies for Life Sciences: An Eli Lilly Case Study
Putting Particulates on the Map
Novavax’s Robinson: Taking Vaccines to the World
More articles »
Drug Delivery
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
Getting More Scientific About Tableting
From the Editor: Ordinary Measures
Are Biosimilars Bound for No Man’s Land?
Webcast: A Look Ahead: The Impact of Biosimilars on the Pharma Landscape
More articles »
White Papers
Avoiding No Man's Land: Potential Unintended Consequences of Follow-On Biologics
Best Practices in Demand and Inventory Planning
SAP Support of the Healthcare Supply Chain’s Ongoing Effort to Ensure Patient Safety and Drive Business Value
Residual Solvents by HT3 Headspace in Reference to USP 467 with a Comparison of Static Versus Dynamic Headspace Analysis
More white papers »
Facilities & Support
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
A Business Case for Isolation Technology
Putting Particulates on the Map
Pharma Facilities: Can One Patent Agility?
Novavax’s Robinson: Taking Vaccines to the World
More articles »
White Papers
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
A Rapid and Sensitive UPLC/UV/MS Method for Simvastatin and Lovastatin in Support of Cleaning Validation Studies
Use of Universal HPLC Detection for Cleaning Validations
How to Prepare for an Inspection of Your Company's Information Integrity
More white papers »
Fill & Finish
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
Getting More Scientific About Tableting
A Business Case for Isolation Technology
Putting Particulates on the Map
Pharma Facilities: Can One Patent Agility?
More articles »
White Papers
Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
SAP Support of the Healthcare Supply Chain’s Ongoing Effort to Ensure Patient Safety and Drive Business Value
Nanoparticles in Pharmaceutical Manufacturing
Case Study: Robotics in an Oral Solid Dose Facility
More white papers »
Industry Developments
Articles
PharmaView: The Great Swine Flu Conspiracy: The Plots Thicken
Digital Insights: Is Apple's iPad Our Future Together?
Funny Pharm: You Write the Caption: March 2010
Taking the Plunge to Harmonize Pharmaceutical Regulations
Speeding Approval in the Era of Electronic Submissions
More articles »
Operational Excellence & Lean Six Sigma
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
Achieving Bottom Line Continuous Improvement Value
OEE at Teva: Leveraging the Simplest KPI
Flexible Pharma: Puzzling Out the Plant of the Future
Automation Fair 2009: Implementing OEE at Teva Parenteral Medicines
More articles »
White Papers
Part 2: Operational Excellence Programs in the Industry: A Tefen Series: OpEx in the Life Sciences
Part 3: Learning from the Industry: A Tefen Series: Operational Excellence in the Life Sciences
Part 1: State of the Industry: A Tefen Series: Operational Excellence in the Life Sciences
The Ninth Waste: The Importance of Energy Efficiency in Lean Manufacturing
More white papers »
Packaging
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
ePedigree: The Rugged Road Ahead
The Path to Epedigree: Manufacturers Chart Their Course
Getting More Scientific About Tableting
Putting Particulates on the Map
More articles »
White Papers
Brandjacking Index: Online Risks in Pharmaceutical Market
Tales from the Counterfeiting Front: USP’s Drug Quality Matrix
Optimizing the Global Manufacturing Network
SAP Support of the Healthcare Supply Chain’s Ongoing Effort to Ensure Patient Safety and Drive Business Value
More white papers »
Process Operations
Articles
Bringing Science to the Plant
From the Editor: Are You Myopic About Risk?
Taking the Plunge to Harmonize Pharmaceutical Regulations
Therapeutic Dose: One Lot a Week?
Biogen Idec, Wyeth Biopharma Create Value from Data
More articles »
White Papers
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
Five Ways to Improve Fiscal Fitness with Rapid Microbial Screening
Three Scenarios for Reducing Raw Material Inspection Costs: How Can You Cut Costs in the Inspection of Your Raw Materials?
Online UPLC Method for the Support of Cleaning Validation and the Routine Monitoring of Cleaning Procedures
More white papers »
Quality Assurance & Control
Unit Operations
Articles
Taking the Plunge to Harmonize Pharmaceutical Regulations
An Open and Shut Case: The Latest in Valves for Bio
Building a New Tech Transfer Model
Putting Particulates on the Map
Bioprocess Sensors: PAT Means Proliferation
More articles »
White Papers
Complying With U.S. FDA Title 21 CFR Part 11 for the Life Sciences Industry
Why CAPA Still Matters
Using a Coriolis Flowmeter's Multivariable Characteristics to Validate Calibration Stability
Reduce Contamination Risk with Advanced Local User Notification Indicators for Remote Particle Counters
More white papers »
Audio Update
- Podcast: Lucky and Good: Sourcing Success Is in the Details Michigan API manufacturer Ash Stevens’ emphasis on clear communication and product quality has (along with good fortune) made it a home-grown success story with an international supplier and client base. Stephen Munk, President and CEO, shares secrets of sourcing success.
- Focus on Pharma Podcast: Pharma Professional and Job Seeker Michelle Alton Cuts Through the Career Advice Clutter Today's life sciences job market is tough, and affecting strategic areas such as clinical development and R&D. Pharma professional Michelle Alton cuts through the conflicting career advice with tips on resume development, networking and a realistic, from-the-trenches view.
- Focus on Pharma Podcast: Is Tech Transfer Broken? How Can We Fix It? We spend billions on drug development, yet precious few products make it to market. Could tech transfer be to blame? If so, why do so many companies get it wrong? In this first installment of our Focus On Pharma podcast series, sponsored by Thermo Scientific, tech transfer experts Stephen Perry, Russ Somma, Emil Ciurczak, and Paul McKenzie explore what’s broken with tech transfer, and how to fix it.
- The Triple Bottom Line: A Strategy Tailor Made for Pharma CEO of Advanced Electron Beams, Mitch Tyson, discusses how pharma companies can strengthen their organizations, and their balance sheets, by adopting the TBL.
- Podcast: This Is Not Your Father’s Coriolis: Flow Measurement Goes Micro We speak with Endress + Hauser’s Joerg Herwig about his company’s partnership with MEMS specialist Integrated Sensing Systems (Issys) and how E+H aims to take all of its products to the micro scale.
- Podcast: Online TOC and Real-Time Release on the Global Stage In the second of this two-part series, Jonathan Yourkin, pharmaceutical market manager with GE Analytical Instruments, provides insight on navigating the subtle, and sometimes dramatic, differences between pharmacopeia and regulators in the U.S. and abroad in regards to the use of online TOC. Yourkin also shares best practices for applying TOC to PAT applications and real-time product release.
- Puerto Rico 2.0: Repositioning an Industry to Restore a Competitive Edge No one needs to tell Puerto Rico the global pharmaceutical market has changed. The island is in the midst of a makeover that will focus on biotech, generics, and outsourcing its 40-plus years of expertise with the aim of keeping the island relevant to pharma. INDUNIV executive director Ivan Lugo talks strategy.
- It’s Good to Be a Scientist: Life Sciences Job Market Holding Firm The turmoil in life sciences and merging of small- and large-molecule manufacturers only enhances the attractiveness of experienced scientists and engineers, says Kurt Moore, president of TalentWRx staffing agency. For those whose careers are in flux, making the most of a temporary position may open doors to something more permanent.
A Report Card for Pharma’s Lean Six Sigma Efforts
Current Trends in GMP Warning Letters
Process Validation Guidance: Light at the End of the Tunnel
Integrating Good Manufacturing Practices During the Transition from Clinical Trials to Commerical Ma
The Impact of Inventory Turns on Speed, Quality, and Costs
From Harmonization to Inspections: An FDA Update
Novartis Goes Wireless for Process and Plant Info
Risk Mismanagement: Where Pharma Companies Err
Thermo Fisher Scientific: New Platform for Benchtop Automation
Podcast: Lucky and Good: Sourcing Success Is in the Details
Podcast: Lucky and Good: Sourcing Success Is in the Details
Focus on Pharma Podcast: Pharma Professional and Job Seeker Michelle Alton Cuts Through the Career Advice Clutter
Focus on Pharma Podcast: Is Tech Transfer Broken? How Can We Fix It?
Webcast: Agility and the Pharmaceutical Facility of the Future
Single-Use Products: Tubing Sets vs. Manifolds
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Webcast Library
- Webcast: Outsourced Manufacturing Strategies for Life Sciences: An Eli Lilly Case Study Outsourcing affords life sciences manufacturers greater flexibility and market responsiveness, and the freedom to focus on core competencies. Outsourcing strategies, however, can vary widely. This webcast will provide an overview of trends and challenges influencing life science companies' outsourced manufacturing strategies, as well as review outsourced manufacturing enabling solutions and technology. The featured speaker will be Tom Blake, who will share outsourcing strategies, processes, KPIs and future direction at Eli Lilly.
- Webcast: A Look Ahead: The Impact of Biosimilars on the Pharma Landscape Follow-on biologics, or biosimilars, will soon become reality in the U.S. Given their inherent complexity and the current state of analytics, how will their safety and quality be ensured? Will they boost or diminish competition and innovation in biotech? Join us for a thought-provoking presentation and panel discussion of these issues.
- Webcast: Tech Transfer: Do We Have a Failure to Communicate? Failure to transfer an analytical method or to move a process from lab to plant can cripple drug development efforts, wasting millions of dollars each year. Why do tech transfer projects fail? How can one ensure their success, whether one is transferring to another department or to a contract manufacturing organization? Join us for a controversial presentation and panel discussion of these issues.

A Transparent Case for Glass Doors
Proactive Contamination Control
Genentech Oceanside’s Continuous Improvement Journey
Getting to Know Your Particles Better