 Event
detail
|
| Dates
: |
From 26/11/2007 to 28/11/2007 |
| Title
: |
FIP Quality-International
2007 Conference: Critical process parameters in the manufacture of
APIs, biologicals, tablets and parenterals |
|
Reference: |
Pharmaceutical manufacturing is going through a
major transition from quality assessment by testing the product at
the end of manufacture to the more holistic control strategy of
quality by design and Process Analytical Technology. This change,
however, requires an enhanced scientific c understanding of the
pharmaceutical processes involved in product manufacture and in
particular a scientific appreciation of the criticality of each
process step. With the advent of quality by design therefore, each
pharmaceutical company will need to implement science and risk based
approaches to evaluate its own processes, determine their critical
steps and necessary controls and establish a design space for each
process. It is essential therefore, that companies have a common
understanding or else it is highly likely that, as a result of
different scientific insights and/or interpretations of criticality,
each company may have a different interpretations of the critical
process steps and the necessary controls, even for very similar
processes. The goal of this conference is to reach a better
understanding of the concept of criticality in general, and how this
can be applied to the most common pharmaceutical manufacturing
processes.
|
|
Location : |
London (UK) |
|
Contact : |
Julie
Churchill |
|
E-mail : |
science@rpsgb.org |
| Phone
: |
+44 207 572 2640 |
| More
info : |
www.rpsgb.org/worldofpharmacy/events/ |
| |
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