Embracing the Quality Risk Management Process as a Means to a Strong Quality Culture
By Cheryl Abernathy, Quality Assurance Operations Manager and Bryan Sasbon is QA Director & Regulatory Affairs
Regardless of whether you are a member of a Quality Assurance department in the pharmaceutical industry or not, the term Quality Risk Management (QRM) is likely familiar to you. This is because QRM, a systematic process that assesses risk to the quality of a drug product across its lifecycle (quality risk assessment), is also often used by a wide range of manufacturing industries when investigating defects during the product development process. Using QRM gives a company the ability to maintain comp...
Source: Pharmaceutical Online News - June 3, 2016 Category: Pharmaceuticals Source Type: news
06.09.16 -- For M&A, Shire Stays Three Dimensional With CMOs
06/09/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 2, 2016 Category: Pharmaceuticals Source Type: news
Phillips-Medisize Acquires Medicom
Phillips-Medisize Corporation (the “Company”) recently announced that it has acquired Medicom Innovation Partner (“Medicom”), a leading provider of device strategy, product design and development services with particular focus on personal connected health drug delivery device solutions to meet the needs of the rapidly growing biopharma and specialty pharmaceutical markets. Terms of the transaction were not disclosed. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 2, 2016 Category: Pharmaceuticals Source Type: news
1,000 Gallon Planetary Dual Dispersers Designed For cGMP Pharmaceutical Manufacturing
Ross recently completed three 1000-gallon Planetary Dual Dispersers, the world’s largest change-can mixers of their kind, designed for cGMP pharmaceutical processing of contrast agents, injectable drugs and other sterile preparations. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 2, 2016 Category: Pharmaceuticals Source Type: news
WuXi Biologics And Sartorius Stedim Biotech Open Joint Laboratory In Shanghai
Sartorius Stedim Biotech, an international leading supplier for the biopharmaceutical industry, and WuXi Biologics recently announced the opening of their Joint Laboratory in Shanghai, marking an exciting new stage in their long-term cooperation. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 2, 2016 Category: Pharmaceuticals Source Type: news
Micromeritics Extends Utility Of 3Flex Surface Characterization Product Family
Micromeritics Instrument Corp. announced recently the addition of an optional TCD (thermal conductivity detector) to their 3Flex Surface Characterization Family of products. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - June 1, 2016 Category: Pharmaceuticals Source Type: news
Siegfried Acquires Hameln Pharma
Siegfried Group will acquire the Hameln Pharma in Germany, consisting of Hameln Pharmaceuticals GmbH and Hameln RDS GmbH, with effect from end November 2014. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 31, 2016 Category: Pharmaceuticals Source Type: news
Long-Term Cooperation Agreement With Celgene
Siegfried and Celgene, the American bio-technology company, have put their existing close cooperation on a firm long-term footing. The agreement, which replaces a cooperation agreement signed in 2006, includes the acquisition of a production building in Pharmapark Siegfried in Zofingen, for which Celgene acquired rights of use including corresponding facilities 10 years ago. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 31, 2016 Category: Pharmaceuticals Source Type: news
06.07.16 -- Overcoming The Challenge Of The 2011 FDA Process Validation Guidance
06/07/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 26, 2016 Category: Pharmaceuticals Source Type: news
Understanding Test Accuracy Ratio, Test Uncertainty Ratio And Application Of Total Uncertainty
Temperature, Humidity monitoring, CO2, dewpoint, differential pressure and other parameters. Vaisala solutions for Continuous Monitoring, standalone data logging, and validation/mapping applications ideal for life science and GxP regulated environments. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 26, 2016 Category: Pharmaceuticals Source Type: news
New Non-Destructive Technology For Blister Package
The VeriPac UBV Leak Detection System is a deterministic non-destructive technology designed specifically for multi-cavity blister packs. The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence of leaks. It’s a simple, rapid 3-step process to test a blister pack. Operators follow these 3 steps:
Input number of blister cavities
Place the blister pack on the inspection plate
Press the START button
Within seconds, the operator sees a definitive pass/fail result, along with a volumetric measurement reading. The location of the defective cavity is also identified. This technology is unique i...
Source: Pharmaceutical Online News - May 26, 2016 Category: Pharmaceuticals Source Type: news
For M&A, Shire Stays Three Dimensional With CMOs
How do biopharmaceutical companies handle CMO and supplier relationships that stem from M&A activity?Who better to ask than Shire? The folks there know M&A and outsourcing as well as anyone in the global biopharma industry today. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 26, 2016 Category: Pharmaceuticals Source Type: news
Grace Sells Chromatography Instruments, Columns, And Related Laboratory Product Lines
W. R. Grace & Co. recently affirmed its commitment to three growing service lines for the pharmaceutical and nutraceutical industries, and announced agreements to sell product lines associated with its chromatography instruments, columns, and related laboratory products businesses that are not aligned with the company’s plans for growth. (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 26, 2016 Category: Pharmaceuticals Source Type: news
Effective Batch Record Review - Getting It Right The First Time
Date: Tuesday, June 28, 2016 Time: 1pm - 2:30pm EDT US Duration: 90 Minutes - Online Price: $299 - Includes Bonus Handouts! (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 25, 2016 Category: Pharmaceuticals Source Type: news
06.02.16 -- Trending: Supply Chain Capacity, Value Calculations, And Serialization
06/02/16 Pharmaceutical Online Newsletter (Source: Pharmaceutical Online News)
Source: Pharmaceutical Online News - May 25, 2016 Category: Pharmaceuticals Source Type: news
