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QbD Definition(ICH Q8(R))
A systematic approach to development that begins with predefined
objectives and emphasizes product
and processunderstanding and process control, based on sound
science and quality risk management
Why QbD?
Higher level of assurance of product quality
Cost saving and efficiency for industry
Increase efficiency of manufacturing process
Minimize/eliminate potential compliance actions
Provide opportunities for continual improvement
Facilitate innovation
More efficient regulatory oversight
Enhance opportunities for first cycle approval
Streamline post approval manufacturing changes and
regulatory processes
More focused PAI and post approval cGMP inspections process
control, based on sound scienc
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Particle size distribution
Particle size may also affect the behaviour of a formulation
during processing and, ultimately,
its content uniformity. In direct compression tableting, for
example, particle size can
influence segregation behaviour, the ease with which powder
flows through the press and the
compressibility of a formulation.Particle size also has a
critical effect on the content uniformity of solid dosage forms,
and it
often matters to create the right relationship between the size
and densities of API and
excipient particles.
Similarly, the size of particles can affect viscosity and flow,
and increasing the polydispersity
of particle sizes in a powder can improve its flow properties.
For example, for many powders
subject to flow in an industrial process, a bimodal distribution
of particle sizes ensures easier
flow during processing.
Particle Analysis TechniquesLaser diffraction
Laser diffraction is a rapid particle sizing technique for both
wet and dry systems. It is a
highly automated and robust technique, even for relatively
unskilled users, once a method
has been successfully developed. Laser diffraction can be used
to develop particle size
specifications at the early stages of a project that can then be
transferred into production via
on-line technology. Many powders have specifications defined in
terms of a particle size and
laser diffraction is used extensively as the sizing technique of
choice for pharmaceutical
quality control.
Imaging, though a more lengthy procedure than laser diffraction,
is much faster than
manual microscopy and produces more statistically relevant data.
With automated
imaging it is possible to obtain data for tens of thousands of
particles in minutes.
Parameters such as circularity, convexity and elongation can be
defined and used to
precisely define the shape distributions of a particle
population
Particle Size and MorphologyMicroscopy
Manual microscopy, and its associated analytical capabilities
are also very valuable additions
to the particle characterisation armoury. Foreign bodies, for
example, are a specific sub-class
of particle that are always unwelcome, but not that uncommon.
Microscopy plays a valuable
role in foreign body identification, especially when linked with
the X-ray diffraction (EDX)
capabilities of the scanning electron microscope. This technique
can provide data on chemical
