Page 7 - Assurance of Sterility for Sensitive Combination Products and Materials

Foreword

The health-care industry is in a time of significant and unprecedented
changes in the sterile products. New therapies are being developed that
combine the benefit of drug products with the specificity of delivery devices.
Global health authorities are becoming more influential in the preparation
of guidance setting expectations for improved process and contamination
control. Innovative manufacturing, sterilization and data acquisition tech-
nologies are available, and the promises of new technologies and modalities
are being constantly introduced. Continuous manufacturing, automation,
and manufacturing intelligence are lowering our reliance on and concern
for the variability of human performance. Simpler standardized clean room
spaces equipped with rapid process monitoring, testing, and manufactur-
ing intelligence data gathering enables improved manufacturing reliability.
Throughout this journey, there is a growing recognition that traditional
product testing, process monitoring, and validation may not be the most
effective means to ensure sterile product quality.
Additional business factors are shaping the industry concurrently with
the advances in technology. Drug and health-care product shortages are
shifting public health policies to emphasize product availability, affordability,
and sustainability. Industry understands that quality processes resulting in
higher yields, increased productivity, and reduced failures makes good busi-
ness sense. The improved profits in turn encourages increased investment in
innovative technologies and the adoption of novel manufacturing strategies
and methodologies.
The opportunities that result from these significant changes increase the
use of technology for manufacturing as well as scientifically based process
control. This provides a vehicle for new approaches for innovative process
improvements incorporating the scientific risk-based approaches encour-
aged by regulators to justify the design and manufacture products approval.
Improvement which challenges the status quo often originates from
asking those critical “why and why not” questions. It is essential that those
responsible for planning, designing, and manufacturing health-care products
employ critical thinking for the efficient development of effective products.
Combination therapies and products emerge to provide effective and
affordable health-care options to our patients. A large proportion of these
products are required to be either sterile or low bioburden. New products

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