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Honeyman PCS |
Process Validation
Process validation is
regarded as a pivotal activity towards assuring pharmaceutical product quality
and demonstrating the capability and robustness of the various processes
involved. The roots of process validation lie firmly in product development,
when critical process parameters and acceptable process ranges are established
either at the laboratory or pilot scale. As the product moves forwards into late
development, further process validations are required to address scale-up or
transfer issues. Process validation is generally regarded as complete when the
so-called consistency lots are manufactured, which demonstrate the reliability
of the process when installed at the final scale and in the commercial
environment.
There is no doubt that
process validation is a costly exercise in terms of resource, material and time
requirements. Furthermore, it is a critical success factor for timely market
authorisation approvals. For this reason, a good strategy of process validation
which is well designed, timely and appropriate is essential.
Not only are new processes
expected to be validated, the traditional acceptance of retrospective validation
for established processes is also being increasingly questioned by the
Regulatory Authorities. Consequently, there are additional challenges emerging
associated with the application of modern process validation principles to
well-established products.
HPCS can provide strategic
and practical support in all aspects of process validation, both pre- and
post-market authorisation. In particular, the following services can be
provided:
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Process
mapping and risk assessments to determine validation requirements
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Preparation of
Site Validation Master plans and project Validation Master plans
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Development of
project-specific validation protocols, reports and validation summaries for
Regulatory submissions (MAA, NDA)
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Systematic
review of validation documentation for compliance to cGMP and / or Regulatory
requirements
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Analytical
support for completing process validation and cleaning validation studies
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Preparation of
Comparability Protocols (EU and US FDA type) for validation of process changes
(pre- and post-approval), scale up or transfer
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Developing
retrospective process validation strategies as well as concurrent validation
studies for established processes
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Preparation of
Annual Product Quality Review (APQR) documentation as a basis for ongoing
retrospective process validation review to meet current US FDA requirements and
imminent EU expectations
With its team of experienced
process engineers, pharmacists, microbiologists, chemists and Regulatory Affairs
specialists, HPCS can provide full project support to most process validation
requirements.
Return to GMP Regulatory Compliance Life Cycle
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