Newsletter | July 10, 2014

07.10.14 -- Analytical QbD at Teva; NIH, NSF Collaborate To Find Markets For Biomedical Research Innovations

 
Pharmaceutical Online Newsletter
» From The Editor
Analytical QbD at Teva: Knowledge Is Power Only When You Share It
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
Featured Focus: Inspection
Using Smart Calibration To Ensure Accurate Weighing
By Steve Watson, Sartorius Intec
Smart calibration; or the ability to commission tank load cells without test weights or flow meters, can significantly reduce the installation cost and improve overall weighing accuracy.
WHITE PAPER: Help Keep Pharmaceuticals Safe: Metal Detection Overview And Guidelines
By Kevin Zarnick, Thermo Fisher Scientific
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless-steel contaminants during the past 40 years in the pharmaceutical industry, it has not been widespread.
WHITE PAPER: 10 Must-Ask Questions When Buying A Pharmaceutical Vision System
BROCHURE: Sterility Testing Isolator
PRODUCT: Package Leak Testing
» Critical Environments
WHITE PAPER: Factors To Consider When Selecting Biodecontamination Services
By Yvonne Yeo, Bioquell Inc.
RBDS (room biodecontamination service) is not only about the practical side of service delivery. We understand that it is important for our customer to hold detailed records of what actions were performed on their site, ready for regulatory or audit inspections, including batch and serial numbers, equipment locations, biological indicator locations, and results. This, of course, is on top of the risk assessment, method statement, contract briefing note, scope of works, and other cycle optimization documentation.
WHITE PAPER: Top 10 Reasons To Use Rigid Wall Isolators
PRODUCT: Fluid Control Systems For Sterilizers And Washers
» Logistics
WHITE PAPER: NIST Traceability: A Calibrated $2 Thermometer Is Still A $2 Thermometer
By Jim Tennermann, Vaisala, Inc.
Everyone in the quality profession has heard the term "NIST traceable." Having calibration traceability to the National Institute of Standards and Technology (NIST) is desirable for most measurement devices. It is also enshrined as a requirement in some regulatory documents. Unfortunately, NIST traceability does not ensure measurement quality.
CASE STUDY: Collecting Human Plasma To Save And Improve Lives
CASE STUDY: Designing 2-8C Shippers For International Shipments From U.S. To Latin America
» Manufacturing
APPLICATION NOTE: Freeze Drying From Small Container Systems
By Margit Gieseler, GILYOS GMBH; and Henning Gieseler, University Of Erlangen
This technical note provides an overview of freeze drying from small container systems, with a focus on the Virtis Freeze Drying System (FDS). Lyophilization from small container systems, e.g., 96-well PCR plates, is particularly attractive for highly potent APIs such as peptides or cytostatic agents. Other interesting applications include high-throughput screening and long-time storage of minimal amounts of samples sensitive to heat and moisture.
BROCHURE: Press Out Universal Deblistering Machine
VIDEO: SacMaster Bulk Bag Unloader
» QA/QC
WHITE PAPER: A Closer Look At Validation In The BioPharma Process
By Ryan Mauro, Validations Sales Specialist, Sartorius Stedim Biotech
Process validation is the collection and evaluation of data throughout the manufacturing process, which establishes, scientifically, that there is consistency of quality, reproducibility, and traceability from batch to batch.
CASE STUDY: Analyzing Big Data Sets From Small Molecules
TRAINING COURSE: Lyophilization Training Course, Sept 22 – 24, Boston, MA
» Packaging
SERVICE: Contract Packaging: Pharmaceutical Solid Dose Or Generics
PRODUCT: Pharmaceutical Liquid Tube Filling And Closing Equipment
PRODUCT: DRcaps Acid-Resistant Capsules
SPONSOR
Outsourced Pharma West Conference And Exhibition
November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA

Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.

Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
UPCOMING TRAINING

Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST

Building An Effective GMP Training System: A Risk-Based Approach
Date: Wednesday, July 30, 2014 • Time: 1:00 pm to 2:30 pm EST
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Ipsen Applies For Multiple Drug Marketing Authorizations
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