ARTICLES BY ROBERT MATJE
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![Drug Serialization]( "FDA's DSCSA Pilot Project Program — Should You Participate?")
FDA's DSCSA Pilot Project Program — Should You Participate?3/4/2019The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?
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![Quality]( "FDA And Quality Metrics: Where Do Things (Currently) Stand?")
FDA And Quality Metrics: Where Do Things (Currently) Stand?7/27/2018Are you ready to give the FDA more? “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no.
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![Contract Pharmaceutical Packaging and Serialization Services]( "Too Little Or Too Late? Perspectives On FDA's New Serialization Guidances")
Too Little Or Too Late? Perspectives On FDA's New Serialization Guidances4/11/2018Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
Robert Matje
Robert "Bob" Matje, PE, CPIP, is a principal of RemTech LLC and has held increasing levels of responsibility in several branded and generic pharmaceutical companies including general management of two pharmaceutical manufacturing facilities, and recently serving as the vice president of technical operations with Endo Pharmaceuticals. Bob has also lead reliability and maintenance, environmental, health and safety, automation, capital and qualification teams and served as the Serialization Project Management Office (PMO) lead for both Endo and Pfizer. This included responsibility for establishing serialization governance, scope development, schedule, and cost. Bob is a member of the International Society of Pharmaceutical Engineering (ISPE) and has served two terms on ISPE’s International Board of Directors. Bob earned a BS in engineering at Lafayette College and an MS in engineering at Villanova University. He is a Registered Professional Engineer in Pennsylvania and was awarded his Certified Pharmaceutical Industry Professional certification in 2012. You can reach him at rmatje@remtechllc.com or connect with him on LinkedIn.