The
World Health Organization (WHO) is revising its guidance on non-sterile
processing validation. The guidance is titled “Revision of the Supplementary
Guidelines on Good manufacturing Practice: Non-sterile process validation.”
Process
validation data should be generated for all products to demonstrate the
adequacy of the manufacturing process. The validation should be carried out in
accordance with GMP and data should be held at the manufacturing location
whenever possible and be available for inspection.
Central
to the guidance is risk assessment, as the guidance states: “risk-based
approach in validation is recommended. The use of in-line, online and/or
at-line controls and monitoring are recommended to ensure that a process is in
a state of control during manufacture.”
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