Split Decisions: Tablet Scoring Under More Scrutiny
FDA provides more direction as questions arise about dosage consistency. Read more »
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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. Read more »
QbD: Redefining Time to Market
For manufacturers who lack formulation and process knowledge, the benefits of getting to market fast can be outstripped by the costs of unexpected failures. Read more »
Funny Pharm: Write the Cartoon Caption & Win
"Funny Pharm," sponsored by Paratherm Corp., features drawings by award-winning cartoonist Jerry King. Submit your caption and win. Read more »White Papers
- Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All evaluations should include a detailed list of specifications to meet your laboratory’s objectives. Most laboratories perform evaluations by examining obvious system attributes and tangible features: work flow, automation, labor and technical requirements, cost of reagents and consumables, capital expenses and interfacing with laboratory information systems. A key component often neglected in the review process is the impact and effect of library databases on performance in a pharmaceutical environment, including comparing comprehensive depth of library entries, accuracy and relevancy to obtain a species level identification.
- Three Steps to Leveraging Expertise in Global Pharmaceutical Production
- Reducing Airborne Contaminants with Polymeric Floor Coverings
- Rotary Tank Cleaning and Cost Savings
- View more white papers »
Events Calendar
Keep track of upcoming events relevant to the pharmaceutical manufacturing industry. Visit our events calendar.
Product Center
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Yaskawa America, Inc.: Z1000 HVAC Drives
Festo: Intelligent Compact Vision Systems Reduce Investment and Production Costs
ATMI Inc: New Single-Use Bioreactor Systems for Improved Performance and Efficiencies in Manufacturing Cell-Based Products
Sensient Pharmaceutical Coating Systems: Spectrafine Plating Grade Natural Colorants
BioVigilant: IMD-A Rapid Biologic Detection System
B&W Tek Introduces Next Generation Handheld Raman Instrument for Material Verification in cGMP Compliant Facilities
Pall's New Sentino Microbiology Pump Simplifies Microbial Analysis
B&W Tek: i-Raman
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
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From the Editor: Adulteration, 21st Century StyleAs legislators and the courts re-examine an old fashioned word, sins of omission will count as much, if not more, than sins of commission. -
PharmaView: Fake Drugs: Why Business is BoomingIt’s time to make counterfeiting less economically tantalizing. -
Digital Insights: Novartis Overtakes Pfizer in 2011 Good Web Buzz RankingsZeta Interactive has published its annual end-of-year Buzz Report, recapping the most buzzworthy pharmaceutical brands’ trends and stories from 2011. -
Therapeutic Dose: Sampling: Good News, Bad NewsChanging from the status quo to meaningful testing will satisfy both FDA and ASTM.
Resource Centers
Aseptic Processing
Articles
Imaging the Blending Process
Process Validation Guidance: A Bad Fit for Aseptic Processing?
Risk Management in Pharmaceutical Microbiology
Therapeutic Dose: Facilius per Partes in Cognitionem Totius Adducimur
Maintaining Integrity: Effects of SIP Sterilization on PTFE Valve Diaphragms
More articles »
White Papers
Rotary Tank Cleaning and Cost Savings
Cartridge Filtration in the Production of Pharma Grade Water
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
More white papers »
Automation & Control
Articles
Managing Pharma Supply Networks in Emerging Markets
Chatterjee: Automation Standards, Statistics and Process Validation
Closed System Control: From Defense to Pharma
To Wire or Not to Wire – Which Option Should you Consider?
Computer System Validation: Eight Challenges on the Way to the Target State
More articles »
White Papers
Pharma 2020: Supplying the Future
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
More white papers »
cGMPs and Compliance
Articles
The FDA Wants More Authority
Process Validation Guidance: A Bad Fit for Aseptic Processing?
From the Editor: Knowledge Transfer and Minimizing Risk
Compliance Update from CBER’s Malarkey: From Sterility Testing to Rapid Methods
FDA Fields Tough Questions About Inspections, Challenges Pharma to Be Open, Honest
More articles »
White Papers
Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
Reducing Airborne Contaminants with Polymeric Floor Coverings
Competitiveness and Regulation: The FDA and the Future of America's Biomedical Industry
Compliance, Risk and Cost of Ownership Comparisons for Pharmaceutical Continuous Monitoring: Wired, Wireless and Standalone Monitoring Systems
More white papers »
Contract Manufacturing
Articles
Rating Pharma Contract Manufacturers: Does Perception Equal Reality?
Win-Win Audits
Quality: Toward a Multidimensional View
Sustainability in the Genes: A Talk With DSM Chief Xander Wessels
On Developing an OpEx Culture at Elan
More articles »
White Papers
Best Practices from Baxter BioPharma: Optimizing Lyophilization and the Empirical Path to Cycle Development
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
Maximizing the Value of Supplier Relationships
Special Report: The Coming of Age of the Indian Pharma Outsourcing Industry
More white papers »
Drug Delivery
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
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
Mitigating Dust Hazards in Oral Solid Dosage Facilities
Groundbreakers: Tomorrow's Drug Manufacturing Facilities
Modular Construction in Pharma: No Longer a Novelty
Drug Manufacturers Seek Remote Control
Facility Design: Finding the Flow
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
Split Decisions: Tablet Scoring Under More Scrutiny
NIPTE, IPEC Work to Standardize Excipient Properties Database
Optimizing Coating Parameters to Improve Tablet Performance by Means of Terahertz Pulsed Imaging (TPI)
Taking the Plunge to Harmonize Pharmaceutical Regulations
Getting More Scientific About Tableting
More articles »
White Papers
Best Practices from Baxter BioPharma: Optimizing Lyophilization and the Empirical Path to Cycle Development
Cartridge Filtration in the Production of Pharma Grade Water
Increasing Tablet Press Productivity Using Segmented Turret Technology
Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
More white papers »
Industry Developments
Articles
Digital Insights: Novartis Overtakes Pfizer in 2011 Good Web Buzz Rankings
Groundbreakers: Tomorrow's Drug Manufacturing Facilities
Pharma Facilities: Modular Gains Momentum
Digital Insights: Pharma's Digital Revolution. Better Late Than Never
PharmaView: Fake Drugs: Why Business is Booming
More articles »
White Papers
A Fact-Based View of the Workforce: Essential to M&A Success
Enhancing Collaboration with the FDA Through MedWatch Plus
Biotech Responds to Dramatic Changes to Innovate in 2010 and Beyond
Six Key Predictors of Outsourcing Success In A Maturing RE & FM Outsourcing Market
More white papers »
Operational Excellence & Lean Six Sigma
Articles
Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?
Therapeutic Dose: Fractal Pharma
Chatterjee: Automation Standards, Statistics and Process Validation
From the Editor: Knowledge Transfer and Minimizing Risk
Risk Management in Pharmaceutical Microbiology
More articles »
White Papers
Three Steps to Leveraging Expertise in Global Pharmaceutical Production
Pharma 2020: Supplying the Future
Industry Insight: Facilitating Continuous Improvement
The Workforce: From Discovery to Production, Increasing Operational Efficiencies in the Pharmaceutical Industry
More white papers »
Packaging
Process Operations
Articles
MedImmune in Frederick: Using Ordinary Tools in Extraordinary Ways
Therapeutic Dose: Sampling: Good News, Bad News
Imaging the Blending Process
Want Better Logistics? Make a Clean Start
Therapeutic Dose: Fractal Pharma
More articles »
White Papers
Special Report: Heat Transfer Fluids: Do's, Don'ts, and Best Practices
Mitigating Process Risk and Cost by Immobilizing Activated Carbon
Satisfying GMP with Handheld Near-Infrared Analyzers in the Pharmaceutical Industry
Handheld Raman Instruments for Pharmaceutical Raw Material Inspection: From the Lab to the Loading Dock
More white papers »
Quality Assurance & Control
Articles
PharmaView: Fake Drugs: Why Business is Booming
QbD: Redefining Time to Market
Ali Afnan: Pharma Faces a New Year: Will it Mirror, or Break Away From, the Past?
Industry Thought Leaders Share Visions and Lessons about Quality for Innovation and Continuous Process Improvement
Win-Win Audits
More articles »
Unit Operations
Articles
Capacitive Humidity Sensors: Advantages and Disadvantages
Design Considerations and Best Practices for Tank Vent Filtration
Transforming Data into Information: An Engineering Approach
RMM Roundup: A Focus on Fast
Life Science Level Measurement: An Update
More articles »
White Papers
The Safest Way to Calibrate: An Introduction to Intrinsically Safe Calibration
Turning Data Into Information: Making Sense of an Avalanche of Supply Chain and Production Data
Zeta Plus Activated Carbon Cartridges Evaluation & Scale-Up for Pharmaceutical Applications
Increasing Tablet Press Productivity Using Segmented Turret Technology
More white papers »
Groundbreakers: Tomorrow's Drug Manufacturing Facilities
Modular Construction in Pharma: No Longer a Novelty
QbD for Better Method Validation and Transfer
Funny Pharm: You Write the Caption & Win: December 2011
CAPA and Root Cause Analysis
Funny Pharm: You Write the Caption & Win: January-February 2012
ISPE Announces 2012 FOYA Winners
Three Steps to Leveraging Expertise in Global Pharmaceutical Production
Yaskawa America, Inc.: Z1000 HVAC Drives
Focus on Pharma: Episode 24: The Facility of Tomorrow: Biopharma Leads the Industry
Focus on Pharma: Episode 24: The Facility of Tomorrow: Biopharma Leads the Industry
AAPS 2011: Over-Encapsulation Presentation from Dr. Brad Gold of Metrics Inc.
Focus on Pharma: Faster Knowledge and Technology Transfer Using Video
Webcast: Supply Chain Security at Pfizer: Threats, Strategies, and Successes
Taking the Emotion Out of Pharma Outsourcing: John Gray Discusses Recent Research into Quality Risks Offshore
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Webcast Library
- 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.
- Webcast: Reinventing Lean in the Pharma Lab In this program, Pfizer’s Ciarán Crosbie and BSM’s Lorcan Mannion illustrate how pharmaceutical laboratories can master the concepts and tools of levelling and flow and achieve significant gains. The presentations are based upon successful implementations at Pfizer’s Grange Castle, Ireland facility.

Excellence by Design: Melissa Herkt on the The Case for PAT and QbD
BIO 2010: Kidding Around with Shionogi's Sico
Panel Discussion: Healthcare Reform and its Impact on the Biopharmaceutical Industry
Market Intelligence Video Report: Quality Management Software Trends: Implementation and ERP Integration
Dan Rather, Pfizer Investigate and Expose Counterfeit Drug Dealer
Market Intelligence Report: How Automated is Your Micro QC Lab?