Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm - Measurement, Monitoring, Modelling, and Control of Bioprocesses - page 238

Fig. 16 Outcome of risk analysis for prioritization of various input and output parameters that
are typically encountered when performing mammalian cell culture processes. Adapted from
Bansal et al. [ 2 ] with copyright permission from Advanstar Communications
2. The lag between the time when the manufacturing process is designed and the
time when routine manufacturing of the product is started in the commercial
facility can be anywhere from 5 to 10 years. A deviation at the time of man-
ufacturing may result in non-conformance, which in turn may require an
investigation to find the root cause and take the necessary preventive and/or
corrective action. If the data created during the development of the process are
available after such a gap of time, they can be used for closure of the non-
conformance. Otherwise, as is typical in the pharmaceutical industry today,
data need to be recreated so that the necessary investigation can be completed,
resulting in spending resources for recreating process data that already exist in
the company. Further, release of the lot will be delayed until such data have
been created and the investigation has been completed.
3. The significant advancements in analytical/bioanalytical chemistry with respect
to development and implementation of new tools, combined with a similar
increase in our ability to collect and store data, have resulted in a very sig-
nificant increase in the amount of data that is routinely generated in a phar-
maceutical company. This has, however, resulted in a challenge with respect to
timely analysis of the data as well as the sharing of the results of the analysis
with the broader organization. This issue has been dealt with in a recent pub-
lication, and the following recommendations were made [ 2 ]:
(a) We need to apply risk management principles towards data analysis. It is
not optimal to collect and analyse all available information with uniform
rigor. For all parameters, a company may continue to record all data on