Pp. 401-440 (40)
The application of the lifecycle model to the pharmaceutical products has
modified existing approaches to quality assurance. The quality of a product is not
simply the outcome of a GMP-compliant manufacturing, but the result of a GMPcompliant
lifecycle. Product development means devising a formula and a
manufacturing process, but most importantly, understanding thoroughly the product.
This, known as quality by design, goes from defining its quality target profile to
identifying the quality attributes of the starting materials and the quality parameters of
the manufacturing process. Critical variables are the hallmark of a product during its
lifecycle. They are identified and studied during the development stage and knowledge
on them is increased during the product’s lifetime. Technological transfer means
confirming that what worked in the development center will also work in the
manufacturing plant, but also increasing and improving knowledge on the critical
variables under industrial-scale conditions. Validation means verifying that the
production process can be successfully controlled by means of the critical variables and
that if these remain within proven acceptable ranges the process can be deemed under
control and consequently yielding quality products. Thus, by monitoring critical
variables each batch can be considered concurrently validated. The application of the
above described approaches will enhance the level of quality insurance of the new
products, but what happens with legacy ones? The model can be usefully applied to
these latter too by using the same principles but proceeding step by step in a reverse
approach, from knowledge to development instead of development to knowledge.
Analytical validation, commercial manufacturing, computerized
systems validation, CPP, CQA, critical variable, DAME, design space,
development, discontinuation, DoE, evaluation, monitoring, PAT, process
validation, proven acceptable range, QbD, QTPP, RTRT, technological transfer.
Glez. Tablas 17, Barcelona, Spain.