FDA process validation guidelines emphasise risk management
pharmafile | February 1, 2011 | News story | Manufacturing and Production |Â Â FDA, ICH, process validationÂ
The FDA has published the final version of its Guideline on Process Validation, more than two years after the first draft was circulated for comment and review.
The take-home message from the new document is a much stronger emphasis on risk management and continuous process improvements, rather than the rigid adherence to initial operating procedures, and maintaining controlled manufacturing processes across a product’s lifecycle.
That represents a major change, and one that is challenging for pharmaceutical companies, which have long equated constancy in operating processes with robust quality assurance.
The new guideline replaces an earlier version first published in 1987 and sets out the general principles and approaches to validating production processes for pharmaceuticals, including biologic drugs and active pharmaceutical ingredients (APIs).
The FDA has needed to update the guideline in light of the activities of the International Conference on Harmonization (ICH), and particularly new ICH guidance on pharmaceutical development (Q8), quality risk management (Q9) and pharmaceutical quality systems (Q10).
The guidelines – available here cover three main areas: Stage 1 is process design, particularly the concept of building in product quality from the outset; Stage 2 is process qualification, to make sure it is capable of “reproducible commercial manufacture”; and Stage 3 is continued process verification, in other words assurance that the process remains in a state of control.
Commenting on the new document, the European Compliance Academy notes that on the whole there are few differences between the final version and the November 2008 draft.
Some points of note include a clarification on the use of viral and impurity clearance studies, greater emphasis on sampling and monitoring during process qualification to identify and control variation, and clarification on the use of new analytical technologies, says the ECA.
Phil Taylor
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