Sunday, 15 September 2013

Process Validation - EMA & US Guidance Comparison

Process Validation  - EMA & US Guidance Comparison


Incorporates product life cycle, QRM and efficient
quality system practices (ICH Q8, Q9 & Q10).
Emphasis on continued process verification through analysis of pre and post release data to provide confidence of an ongoing valid process.
Acknowledgement and provision of scope to emerging processing technologies, such as PAT, to assist the validation effort.
Enhanced detail to provide understanding of regulator expectation on what constitutes an appropriate validation effort.
Definition “documented evidence that the process,
operated within established parameters, can
perform effectively and reproducibly to produce a
medicinal product meeting its predetermined
specifications and quality attributes.”
Definition “the collection and evaluation of data,
from the process design stage throughout
production, which establishes scientific evidence
that a process is capable of consistently delivering
quality product.”
The EMA draft guideline states “a minimum of
three consecutive batches”, with justification to
be provided (there are some exceptions to this
The US FDA guidance states that the number of
batches must be sufficient to provide statistical
confidence of the process. It is a subtle, but
important distinction in the approaches.
The US FDA guidance emphases documenting the
development phase as part of PV.
The EMA draft
encourages the use of the product development
activities, but is less prescriptive on requirements.
The EMA guideline specifically allows the use of
CPV to replace traditional validation efforts.
US FDA approach does not place high emphasis on
CPV, and requires all three stages of process validation to be fully addressed, regardless of whether contemporary or traditional methods are utilised.
The US FDA guidance considers equipment and
process design, as well as equipment qualification
as part of the overall process validation effort.
The EMA guideline sees process as independent
from equipment and facility. Currently, the EMA
still relies on Annex 15 of the GMP guide for
instruction on equipment qualification.


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