Roche Gets to the Core of MES
The manufacturer’s global rollout of a centralized MES system will not happen quickly or easily, but is already resulting in error and deviation reductions in the 80%-90% range. Read more »
The “Intended” Consequences of Software Validation
Compliance specialist Michael Gregor puts the spotlight on software validation, and tells us why FDA is doing the same. Read more »
Tech Transfer: Do It Right the First Time
What dooms many tech transfer projects is a failure to communicate and plan. 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
- Enhancing Collaboration with the FDA Through MedWatch Plus This white paper will provide an overview of the benefits and best practices of using the FDA's MedWatch Plus initiative for electronic adverse event reporting within the pharmaceutical industry, as well as other FDA-regulated organizations.
- Biotech Responds to Dramatic Changes to Innovate in 2010 and Beyond
- Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
- Avoiding No Man's Land: Potential Unintended Consequences of Follow-On Biologics
- View more white papers »
Events Calendar
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Product Center
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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
Endress+Hauser Promass 83 Connectivity Extended
Practical Method of Critical Document Retrieval
Waters Ships First Units of SYNAPT G2 Mass Spectrometer
Antimicrobial Coating for Overlays
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?
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From the Editors
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From the Editor: Ordinary MeasuresEverything I needed to know I learned in Freshman Chemistry 101 -
PharmaView: Via the Blog, a Pharma Star is RebornBy blogging and networking, Michelle Alton beat the unemployment blues. -
Digital Insights: The Pharma Job Search: Exhaust All ResourcesWith the unemployment rate in pharmaceuticals and life sciences estimated at an alarming 16%, it’s best to be proactive. -
Therapeutic Dose: New Year, New HopePharma may not be adopting PAT and QbD wholesale, but smaller, more powerful hardware offers a glimmer of hope.
Resource Centers
Aseptic Processing
Articles
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
Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing
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
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
Lilly Looks to Cloud 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
Contract Manufacturing
Drug Delivery
Articles
Are Biosimilars Bound for No Man’s Land?
Webcast: A Look Ahead: The Impact of Biosimilars on the Pharma Landscape
Flexible Pharma: Puzzling Out the Plant of the Future
Webcast: Agility and the Pharmaceutical Facility of the Future
From the Editor: Excipients: Out of Sight, Not Out of Mind
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
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
Flexible Pharma: Puzzling Out the Plant of the Future
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
A Business Case for Isolation Technology
Putting Particulates on the Map
Pharma Facilities: Can One Patent Agility?
Flexible Pharma: Puzzling Out the Plant of the Future
Webcast: Agility and the Pharmaceutical Facility of the Future
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
Operational Excellence & Lean Six Sigma
Articles
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
Market Intelligence Report: Tracking Your Workforce
Webcast: Agility and the Pharmaceutical Facility of the Future
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
Putting Particulates on the Map
HP’s Simske: When Manufacturing and Packaging Merge
Flexible Pharma: Puzzling Out the Plant of the Future
Automation Fair 2009: Track-and-Trace at Bosch Packaging Services
Webcast: Agility and the Pharmaceutical Facility of the Future
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
Biogen Idec, Wyeth Biopharma Create Value from Data
Building a New Tech Transfer Model
Putting Particulates on the Map
From the Editor: Stop Throwing Processes Over the Wall
Therapeutic Dose: New Year, New Hope
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?
The Executive Guide to Contracts & Chargeback Management
More white papers »
Quality Assurance & Control
Articles
Design for Six Sigma: A Potent Supplement to QbD
Therapeutic Dose: Residual Solvents and a Trace of Cooperation
From the Editor: Stop Throwing Processes Over the Wall
Therapeutic Dose: New Year, New Hope
Ciurczak: Thoughts of the Future of Pharma
More articles »
White Papers
Tales from the Counterfeiting Front: USP’s Drug Quality Matrix
Accounting for Risk in Your Asset Management Strategy
Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
Implementing PAT and QbD? Real-time Particle Size Measurement for the Pharmaceutical Industry
More white papers »
Unit Operations
Articles
Building a New Tech Transfer Model
Putting Particulates on the Map
Bioprocess Sensors: PAT Means Proliferation
For Measurement Technologies, It’s a Smaller World After All
Flexible Pharma: Puzzling Out the Plant of the Future
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: 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 World Beyond ICH: WHO, ISO Must Figure Prominently in Harmonization Regulatory harmonization has made great strides, but if efforts are to become truly global the World Health Organization must be involved. In this audio interview, Birgitte Holst, Manager of Manufacturing Science & Quality at Novo Nordisk, discusses pharmacopeia, terminology, anticounterfeiting, and more.
- Maximize Uptime and Cycle Times with Rapid Microbial Methods Rapid Microbial Methods offer a much faster alternative to traditional plating to detect microbes in raw materials, in-process and finished goods. In this 15-minute audio interview, John Albright, Regulatory and Compliance Manager with Celsis, discusses the company’s Rapid Microbial platform, potential ROI and impact on capacity utilization and cycle times, as well as method validation.
Digital Insights: The Pharma Job Search: Exhaust All Resources
Taming the Scheduling Beast
Roche Gets to the Core of MES
Design for Six Sigma: A Potent Supplement to QbD
Tech Transfer: Do It Right the First Time
Design for Six Sigma: A Potent Supplement to QbD
EMA 'Road Map' Outlines Supply Chain Security Plans
Enhancing Collaboration with the FDA Through MedWatch Plus
Waters Corp.: ACQUITY UPLC H-Class System; HPLC Simplicity with UPLC Performance
Podcast: Is Tech Transfer Broken? How Can We Fix It?
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Webcast Library
- 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.
- Webcast: Agility and the Pharmaceutical Facility of the Future Economic realities and market pressures demand agility in pharmaceutical manufacturing as never before. What technologies promise to transform laboratories and manufacturing facilities as we know them today? What will the typical pharma plant look like in twenty years? In this webcast, experts share their views on transformative technologies, existing facilities that set new benchmarks for the industry and what the future holds. Q & A to follow the speaker's presentations.

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Proactive Contamination Control
Genentech Oceanside’s Continuous Improvement Journey
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