AGAWAM, Mass., March 19 /PRNewswire/ -- For pharmaceutical manufacturers, the process of choosing a Contract Manufacturing Organization (CMO) can be a challenging task. The ramifications of making a poor decision can result in schedule delays, regulatory approval issues, and lost revenue.
The informative white paper, "Selecting An Aseptic Fill/Finish Contract Manufacturer: Avoiding the Most Common Mistakes," focuses specifically on the unique steps involved in selecting and working with an aseptic processing CMO to produce injectable Final Drug Product (FDP). Download it at: http://www.microtestlabs.com/asepticpaper.
In addition to providing guidance on the selection process, the white paper also discusses common mistakes made by potential clients. These oversights -- and their remedies -- are sourced from a collective experience base that covers contract aseptic Fill/Finish (F/F) manufacturing, contract bulk drug manufacturing, and aseptic F/F outsourcing of bulk drug product.
The white paper is authored by John Dobiecki, Vice President of
Manufacturing Operations for Microtest Laboratories. Dobiecki's experience,
which spans 25 years in the manufacturing and quality control of
pharmaceuticals, medical devices, and biologic products, includes the
preparation of INDs, NDA/ANDAs, CMC sections, and Pre-Approval Inspections
(PAI), as well as multiple U.S. and European Regulatory Inspections.
In the white paper, Dobiecki:
-- Details the nine key components of the RFP -- The First Step (in the
-- Discusses the finer points of Evaluating the Contractor's Proposal
-- Explains the two types of Site Visits and what should be included on
-- Provides cautionary tips for making The Selection itself
-- Warns of stumbling into making The Biggest Mistake which can derail a
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