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world. DuPont supported their customers by gaining alignment with the
regulatory bodies which included providing data with multiple methodol-
ogies to support the change assessments and notifications.

5.3.3.5 Validation of test methods
Validation of packaging test methods has been a subject of intense discus-
sion in the medical device industry since the introduction of ISO 11607
“Packaging for terminally sterilized medical devices” in 2006. Unlike the medical
device industry, the pharmaceutical industry has diligently embraced the con-
cept of validation in analytical procedures for identification, and quantifica-
tion of impurities and active ingredients. US and European pharmaceutical
products regulatory requirements are captured as a part of good manufactur-
ing practice (GMP) (US: 21CFR211.165, EU: Volume 4 EU Guidelines to
Good Manufacturing Practice [62], guidance in ICH Q2(R1) [63] accepted
by the FDA, EU, and Japan). The purpose of validation is to provide docu-
mented evidence to demonstrate that a method fulfills the requirements for
its intended use, in other words, that it is suitable for its intended use.
The ASTM made significant contributions in the area of test method
validation with its rigorous approach for conducting interlaboratory studies
to determine the precision and bias of a test method (see ASTM E691 [64])
The precision is determined by establishing the repeatability or the variabil-
ity between measurements produced by the same equipment and operator,
respectively, the reproducibility or the variability between measurements
between different test equipment, operators, and/or test laboratories. The
precision and bias section, included in each standard, gives an indication
about the limits of detection of the method as well as the typical variability,
which is required when selecting adequate test methods and when imple-
menting the test method in a laboratory.
Test method selection, implementation, validation can be onerous tasks
and it is important to keep the identified risk to the patient in mind in
relation to packaging design aspects to be assessed. Validation should cover
limits for the intended application and not the method’s theoretical capa-
bility. Guidance for SBS test method validation can be found in annex O
of ISO TS 16775 [38]. General principles and definitions are available in
ISO 5725-1 [65], a basic method for the determination of repeatability and
reproducibility is proposed in ISO 5725-2 [66].

5.3.4 Design validation
Design validation and process validation of a specified SBS are two dis-
tinct activities, although they are done together. Design validation includes