These scientific principles and bes

These scientific principles and best practices apply to all organizations and individuals involved in the manufacture, market- ing, and qualification of drug products and in their stability studies, including but not limited to:• Manufacturers of drug products for human and veterinary use where manufacturing may involve operations at the appli- cant holder's facilities (i.e., facilities that belong to the holder of an approved New Drug Application or Abbreviated New Drug Application) or at those of a contractor for the applicant holder• Manufacturers of combination drug products• Packaging operations by the manufacturer or a designated contractor for the applicant holder• Repackaging operations in which the drug product may be owned by an organization other than the primary manufac- turer.Although it is ultimately the drug product applicant's responsibility to ensure that appropriate leachables assessments are completed, manufacturers and fabricators of pharmaceutical packaging/delivery systems, packaging components, and materi- als of construction should also apply these scientific principles and best practices as appropriate, and applicants are encour- aged to work with component manufacturers and fabricators to this end.