ABSTRACT
Pharmaceutical products are more than formulations, the
product must be supplied in a primary package system
that protects its quality from time of manufacture until
ready for use, and the proper delivery of the product may
be supported by the packaging system as well, with
regard to dose, safety and other attributes. This is true
of all pharmaceutical dosage forms, and while it is of
particular importance for sterile products, the proper
preparation of containers is essential to all drugs. This
chapter will review the validation concerns for primary
packaging components, specifically containers and
closures used in the packaging of sterile and nonsterile
products prior to filling. The treatment of this topic in
earlier editions of this text (1) addressed the develop-
mental and selection physical and chemical attributes of
polymeric closures, and the presterilization processing of
closures and sterile glass containers. This chapter
expands and updates the types of materials to include
plastics, and explores nonsterile dosage forms, while only
referencing sources for developmental andmaterial selec-
tion information. The approach excludes traditional
autoclaving, dry-heat depyrogenation, and online postfill
container integrity testing technologies. These topics are
addressed elsewhere within this volume or in widely
available references. The relationship with packaging
component suppliers for both quality and outsourced
preparation will be addressed. The chapter will suggest
methods for validating preparation operations from a
practical viewpoint of the validation team and those
functions directly supporting the validation effort.
