Newsletter | July 24, 2014

07.24.14 -- What You Missed From The FDA Last Week; Merck's Continuous Process Improvement

 
Pharmaceutical Online Newsletter
» Featured Magazine Article
Merck's Continuous Process Improvement
By Gail Dutton, Contributing Editor
Continuous improvement doesn't just depend upon Lean principles and/or zero-based budgeting. It depends upon people inspired by a culture that values learning, promotes problem-solving skills, and striving toward big goals by making small improvements every day.
Featured Focus: Critical Environments
Achieving Automation Of Hygienic Production Processes
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Standards such as HACCP (Hazard Analysis and Critical Control Points) for food processing and GMP (Good Manufacturing Practice) for FDA-compliant processes in the pharmaceutical industry define extremely stringent requirements for cleanliness, safety, and product quality.
WHITE PAPER: Spore Control In Pharmaceutical And Biotech Manufacturing Environments
DATASHEET: Eliminate Transfer Contamination With Hydrogen Peroxide Vapor (HPV)
By Bioquell Inc.
APPLICATION NOTE: Improve Root Cause Investigations With Real-Time Facility Monitoring
PRODUCT: Custom Pharmaceutical Sterilizers
» Packaging
ARTICLE: Beyond Desiccants: Sorbent Technology Embraces New Challenges
By Adrian Possumato, Global Director, Healthcare Packaging, Multisorb Technologies
Scientific advances in the pharmaceutical industry have given rise to new stability challenges and consequently, have created an increased need for more advanced desiccants, moisture regulators, oxygen absorbers, and other forms of sorbent technology.  In this competitive market, taking a QbD approach by introducing the use of sorbent technology during the early development stages becomes critical to getting your product to market ahead of competitors.
CASE STUDY: Smart Cameras Reduce Implementation And Validation Costs In Pharmaceutical Serialization
PRODUCT: Pharmaceutical Dosing And Filling: API
» Inspection
ARTICLE: A Process Analytical Technology (PAT) Approach To Automated Container Closure Integrity Testing (CCIT)
By Andrea Simonetti, TASI Group, Bonfiglioli Engineering and Sepha
This article provides an overview of the process analytical technology (PAT) methodology application to automated equipment developed for 100 percent container closure integrity testing (CCIT) of pharmaceutical items.
Syringe Headspace Oxygen Analyzer
By Lighthouse Instruments
PRODUCT: Microleak Testing Syringes, Vials, And Other Pharmaceutical Containers
» Manufacturing
Manufacturers Reducing The Burden Of Compliance
By Tara S. Hundley, Anton Paar USA
What drives a pharmaceutical company to scrutinize an instrument manufacturer and every detail of the instrument during instrument qualification? The answer is simple, compliance to regulations. Every company that produces pharmaceutical products must guarantee a consistent quality that meets regulated specifications — for the entire product life cycle, from production to consumption.
PRODUCT: Used Pharmaceutical Blenders
PRODUCT: VHP Remote Particle Counters
» QA/QC
WHITE PAPER: 5 Common Misconceptions In Freeze Drying
By Dr. Laura Ciccolini, Commercial Director, Biopharma Technology Limited
Freeze drying (lyophilization) is a stabilization method that is widely used in the pharmaceutical industry for drugs, vaccines, antibodies, and other biological material. Freeze drying can be a complex process to handle effectively, but despite improvements in analytical and process science a number of misconceptions persist. Below we look at a selection of those we encounter most often. 
BROCHURE: Handheld Raman Analyzer For Raw Materials Verification: ASSURx Brochure
BROCHURE: EMC Documentum Quality Manufacturing Solution For Life Sciences
» Logistics
WHITE PAPER: Clinical Trial Logistics In India: The Efficient Importation Of Investigational Drugs
DATASHEET: Medical Devices And Diagnostic Equipment Logistics Services
By Marken
BROCHURE: AT&T mHealth Solutions Brochure
UPCOMING TRAINING

Improving Biological Facility Design: Critical Tips for Compliance
Date: Wednesday, August 6, 2014 • Time: 1:00 pm to 2:30 pm EST

Serialization Preparedness: What You Must Know For Bullet-Proof Programs
Date: Tuesday, August 12, 2014 • Time: 1:00 pm to 2:30 pm EST

Lyophilization: An Introduction To The Scientific Principles
Date: Wednesday, August 20, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
India Shifts Stance On Pharma Serialization Compliance, Surprises Industry
West Pharma Has High Hopes For New $15M Indian Facility
TSI Completes Drug Master File for the BioTrak Real-Time Viable Particle Counter
NICE Cancer Drug Restrictions Block Care To Patients, Research Shows
What You Missed From The FDA Last Week — July 14 To 18, 2014
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