Newsletter | March 18, 2014

03.18.14 -- FDA And Industry Experts Offer Guidance For DQSA Preparation

Pharmaceutical Online Newsletter
Inspection Manufacturing QA/QC
Logistics Packaging Critical Environments
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» From The Editor
FDA And Industry Experts Offer Guidance For DQSA Preparation
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
It's been more than three months since President Obama signed the Drug Quality and Security Act (DQSA) into law, and some of the industry is still unsure how to proceed with preparation for Title II, which outlines the plan for supply chain security. In a recent discussion with Pharmaceutical Online, Ilisa Bernstein, Pharm.D, JD, deputy director of the U.S. FDA Office of Compliance in the Center for Drug Evaluation and Research (CDER), encouraged the industry to familiarize itself with the law and the requirements under it.
Featured Focus: Inspection
Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
By Sergio Mauri, Manager, BU Integrated Projects, Fedegari Group
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, high-speed lines have been designed to supply the patients with "multipurpose" small molecule drugs to cover the huge worldwide demand of health for the most common diseases. The next generation drugs will focus on the single patient and be designed to cover the individual health demand. For instance, biotech products and large molecules are the most promising therapeutic means for treatment of different kinds of cancer.
CASE STUDY: Avoid Product Recalls With Tablet Vision Inspection System
DATASHEET: Portable Airborne Particle Counters: SOLAIR
By Lighthouse Worldwide Solutions
DATASHEET: Self-Contained Smart Camera: In-Sight
By Cognex Corporation
DATASHEET: IQ+ FreeFall Metal Detection
By Loma Systems and Lock Inspection
PRODUCT: Nondestructive In-Line Leak Tester For Vials
» Manufacturing
WHITE PAPER: A Guide To IBC Blending And Handling Systems
By Jeff Montross, Regional Sales Manager, Servolift
With respect to the proper deployment of an intermediate bulk container (IBC) blending and handling system, it is always important to look closely into the handling of the IBCs from a before and after blending perspective. A comprehensive plan for IBC handling can optimize your process and eliminate inefficiencies.
WHITE PAPER: Designing An Effective Pharmaceutical Containment Blending System
By Denise McIntosh, Custom Powder Systems
The same pharmaceutical intermediate bulk container (IBC) that is used for shipping and storage can also be used for blending.
WHITE PAPER: Basic Principles Of Dry Granulation And Roller Compaction Technology
DATASHEET: DFS Flow Meter Filler
By Filamatic
DATASHEET: High-Pressure Homogenizer And Pump
By GEA Niro Soavi
DATASHEET: Tablet Deduster, Metal Detector And Diverter Combination Unit
By Kraemer US LLC
PRODUCT: Unused Watson Marlow Filling And Capping System
ARTICLE: Understanding Test And Measurement Equipment Performance In The Laboratory
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.
WHITE PAPER: Airborne Particle Monitoring: Impact Of ISO 21501-4 Calibration
By Joe Gecsey, MET ONE/Hach Company
Dependable, consistent, and repeatable results in monitoring airborne particles in cleanrooms and clean zones depends both on the sampling technique of the analyst and on the performance of the particle counting instrument. The control of the sampling technique often is the subject of a unique SOP (standard operating procedure) while the performance of the instrument is typically reviewed and verified through an annual or semiannual calibration process.
APPLICATION NOTE: Continuous Monitoring Of Microbial Contamination With Instantaneous Results
APPLICATION NOTE: How To Leak-Test Blisters
PRODUCT: Electrokinetic Analyzer For Solid Surface Analysis: SurPASS
» Logistics
CASE STUDY: Supporting Global Medicinal Delivery At The Right Temperature
VIDEO: LoJack's Unique Relationship With Law Enforcement
SURVEY: Assessing The Future Of The Cold-Chain Industry
PRODUCT: Flexible Intermediate Bulk Containers
» Packaging
GUEST COLUMN: Challenges In Choosing The Right Sorbent
By Adrian Possumato, Vice President, Healthcare Packaging
Maintaining drug stability, quality, shelf life, safety, and efficacy is often achieved by using a sorbent to manage moisture, remove oxygen, or eliminate volatiles in the drug or device packaging headspace. With so much at stake, sorbent insertion is a critical step in the pharmaceutical packaging process.  Unfortunately for manufacturers, automated insertion can create challenges on the packaging line when not properly implemented by a reputable supplier that can offer technical expertise and customized solutions.
WHITE PAPER: Track And Trace: The Fight Against Counterfeit Products
WHITE PAPER: Wallet Packaging Trends For The Pharmaceutical Industry
CASE STUDY: 100 Percent Container Closure Inspection Of Freeze-Dried Drug Product In Quarantine
SERVICE: Contract Packaging: Pharmaceutical Solid Dose Or Generics
» Critical Environments
WHITE PAPER: Risk Mitigation When Evaluating Cleanroom Construction Materials
By Maik Jornitz, COO, G-Con
Reducing the cost of goods sold has become a focus of pharmaceutical facility, cleanroom, and process design, especially as blockbuster patents have begun to expire and generic competition has intensified. The need to minimize manufacturing costs sparked a multitude of creative ideas.
WHITE PAPER: Building Safety Into Isolator Controls Systems
APPLICATION NOTE: Vapor Phase Hydrogen Peroxide
DATASHEET: Alcotabs: Critical-Cleaning Detergent Tablets
By Alconox, Inc.
PRODUCT: Biodecontamination Of Pharmaceutical Containment Systems
PRODUCT: Custom Pharmaceutical Sterilizers

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Tuesday, March 25, 2014 • Time: 1pm – 2:30pm EST

Quality Agreements And FDA: What You Must Know To Comply
Date: Wednesday, April 2, 2014 • Time: 1pm – 2:30pm EST

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST
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