The Food and Drug Administration have set up new guidelines that are more fitting for the 21st century than those implemented back in 1987. These stipulations are for the Current Goods Manufacturing Processes' process validation. This presentation explains the guidelines.

2.  The Food and Drug Administration have set
up new guidelines that are more fitting for
the 21st century
 Better then the ones set in 1987
 Stipulations are for the Current Goods
Manufacturing Processes' process validation

3.  Compliance specialist Michael R. Goodman
with Compliance Insight says there are new
key points to these current guidelines
 Development concepts for modern
pharmaceuticals
 Quality risk management will be set up
 All stages of the manufacturing process have
quality systems in place

4.  Immediate and evident benefits that the
pharmaceutical companies can expect
 Before entering the supply chain, variations would be fully
checked to prevent any contaminants from entering
 Product's quality critical attributes would be better-
monitored in-process
 Greater checks on changes in the supply chain that may go
unnoticed or the process drift
 Growing dependence and risks on CMOs or manufacturing
companies that make various drugs for various companies
with different risks on contract would be lessened

5.  New approach is named ‘Quality by Design’
has each step characterized throughout the
various processes
 According to Goodman
 This approach has a process validation that is
fragmented so that every step will be defined
using an evaluation as being critical or non-critical
by the manufacturers

6.  The following evaluation is used to define the
steps
 Defining the purpose of every step
 Defining its operating range
 Defining the variability impact within that
operating range
 Defining the process performance impact for
reaching that range

7.  Fragmented approach will help to better
understand and control effectively all of the
processes
 Will also help monitor the processes more
actively
 Answering these questions during the
process phase of development may be quite
costly and time-consuming

8.  Pharmaceutical companies should define
critical steps
 Find an acceptable range and to separate
anything that can be considered critical crucial in
order to scale-up successfully
 Helps to define range of operations clearly

9.  When operating range is weak it can lead to
excessive use of materials
 Ingredients used in large concentrations or affect
investigations that are out-of-specification from
an unknown cause
 Research study with total transparency would
lessen the requirement for transfer of
verification technology

10.  Goodman goes on to explain that process
analytical technologies should be used by
pharmaceutical manufacturers
 These include
 Process controls
 Process analyzers and
 Tools for acquiring multivariate data
 Guidelines have recently been issued by the
FDA that are founded on the idea of
embracing today's new technologies

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