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Topics - Quality


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By Kristin Brooks
Published February 20, 2014
Allows companies to outsource biologic QC testing Read More »
By Gil Roth
Published February 5, 2014
First-year goals met Read More »
By Gil Roth
Published January 8, 2014
No observations at Manchester, NH site following GMP/PAI visit Read More »
By Kristin Brooks
Published December 20, 2013
To use MODA-EM for environmental and utility monitoring programs Read More »
By Gil Roth
Published December 19, 2013
Potential $4.3 billion deal plus royalties through 2025 Read More »
By Gil Roth
Published December 18, 2013
CMO issues apparently resolved Read More »
By Gil Roth
Published December 10, 2013
Spokane CMO facility cited by agency Read More »
By Gil Roth
Published November 18, 2013
Combines microbio validation and screening with rapid detection platform Read More »
Dequantify Yourself
By Rick Piazza, Medidata
Published November 13, 2013
Are all those system metrics your friend or foe? Read More »
The Wild West of Basic Discovery
By Nancy Gillett, Charles River Laboratories
Published November 13, 2013
R&D outsourcing issues Read More »
Newsmakers: Frithjof Holtz on EXCiPACT
By Gil Y. Roth, Contract Pharma
Published October 9, 2013
In July, Merck Millipore completed an audit for EXCiPACT, a new voluntary standard for pharmaceutical excipient suppliers. We talked to Frithjof Holtz, head of MM-QS Advocacy, Merck Millipore Quality and Regulatory Management, about the pro… Read More »
By Jason S. Collins, IPS-Integrated Project Services
Published October 9, 2013
Aseptic processing designs must advance Read More »
By Heather D. Banuelos, Hunton & Williams LLP
Published October 9, 2013
Evaluating IRB responsibilities and determining IND exemptions Read More »
Picking Tomorrow’s Winners
By Peter Pollak and Andrew Badrot, CMS Pharma
Published October 9, 2013
Review the business development cycle in the custom manufacturing industry and assess risks associated with pharmaceutical fine chemicals manufacturing Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
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