<1663> ASSESSMENT OF EXTRACTABLES ASSOCIATED WITH PHARMACEUTICAL PACKAGING/DELIVERY SYSTEMS
SCOPE
The scientific principles and best-practices described in this general chapter are intended to apply to any extractables assessment or extraction study of pharmaceutical packaging/delivery systems, packaging components, or materials of construction; the results of which are intended for establishing extractables profiles. Extractables profiles can be used in a variety of pharmaceutical development and manufacturing applications, including the characterization, selection and qualification of materials of construction, packaging components or packaging/delivery systems; establishing leachables-extractables correlations; and/or simulating worst-case drug product leachables profiles. These scientific principles and best practices can also be applied to materials of construction and functional components of equipment used to manufacture drug substances and drug products; e.g., filters, tubing, and tanks. In addition, these principles and best practices can be applied to materials of construction for the medical device component of a combination product (2), with appropriate consideration of the guidances and regulations that apply specifically to medical devices. These scientific principles and best practices apply to all organizations and individuals involved in the manufacture of drug substances, drug products, and in their stability studies, including but not limited to:
- Manufacturers of drug substances and drug products for human and veterinary use where manufacturing may involve operations at the applicant 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 products
- Packaging operations by the manufacturer or a designated contractor for the application holder
- Repackaging operations in which the drug product may be owned by an organization other than the primary manufacturer
Manufacturers and fabricators of pharmaceutical packaging/delivery systems, packaging components, and materials of construction may also apply these scientific principles and best-practices as appropriate.