pharmaceutical industry laboratoryaccreditationstandard ISO/IEC 17025CGMPcompetitivenessCurrent Good Manufacturing Practice (cGMP) being a legal regulation in developed countries will become a legal regulation in Republic of Serbia starting with March 2010. In this paper comparative analysis between requirements...
Host Jeremy C. Park talks withSam Potts, Owner, andJustin Miller, Director of Commercial Division forMetro Logics, Inc., who both highlight the third-party logistics company based in Olive Branch, MS, which provides warehousing and rapid distribution services for perishable foods, pharmaceutical p...
Schmitt:Although the entire FDA guidance should be paid close attention to, one particular aspect of interest to manufacturers relates to ‘Approving or Rejecting Changes that Affect Product Quality and cGMP Compliance’ (Case 5 of the guidance). Change management can be challenging when a sponsor ...
Magdalena R. Mejillano is the vice president of operations, cGMP laboratory PPD, Inc., 608.203.4027, Magdalena.Mejillano@madison.ppdi.comChris Lively is director, biopharmaceutical testing; Stacey Sullivan is director, business development. Articles...