Page 104 - Assurance of Sterility for Sensitive Combination Products and Materials

88 Assurance of sterility for sensitive combination products and materials

Table 5.2 An example of the necessary information for a container/closure system to
be included in an original drug product application—cont’d
Quality For Each Packaging Component Received by the Applicant:
control • Applicant’s tests and acceptance criteria
• Dimensional (drawing) and performance criteria
• Method to monitor consistency in composition, as appropriate
For Each Packaging Component Provided by the Supplier:
• Manufacturer’s acceptance criteria for release, as appropriate
• Brief description of the manufacturing process
Stability • See section III.C.4

FDA ‘Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics’
page 22, May 1999 [24].

5.2.4 Container types/definitions/dosage form
There are numerous container types and dosage forms, including packaging
systems and features that are not necessarily terminally sterilized, but are
hermetic or tightly closed. As dosage forms evolve, future systems may offer
a solution for a novel product that also requires terminal sterilization.
The United States Pharmacopeia (USP) classifies containers by their abil-
ity to protect their contents from the external environment. At a minimum,
the container must be well closed to protect the contents from contamination
under ordinary conditions of handling, storage, and distribution. A tight con-
tainer protects the contents from contamination by extraneous liquids, solids,
or vapors, from loss of the article, and from efflorescence, deliquescence, or
evaporation under the ordinary or customary conditions of handling, stor-
age, and distribution, and is capable of tight reclosure. A hermetic container is
impervious to air or any other gas under the typical conditions of handling,
shipment, storage, and distribution. Sterile hermetic containers generally
hold preparations intended for injection or parenteral administration. A light-
resistant container is intended to provide protection from light (Fig. 5.1).
Containers are further categorized based on the number of doses it con-
tains. A single-dose container is one that holds a quantity of drug intended as a
single dose and when opened cannot be resealed with confidence that ste-
rility has been maintained. These containers include fusion-sealed ampules
and prefilled syringes and cartridges (Fig. 5.2).
A multiple-dose container is a hermetic container that permits withdrawal
of multiple doses from the contents without impacting the strength, quality,
or purity of the remaining contents, for example, vials (Fig. 5.3).
Parenteral products are administered by breaching the skin barrier. This
common effective method of delivering combination products enables