FDA Biomanufacturing Inspection Plan: Risky Business
Feb 6, 2018 18:19:08 GMT
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Post by icemandios on Feb 6, 2018 18:19:08 GMT
Essentially, the proposed revamp of the FDA inspection program leaves the frequency of inspections up to the inspectors. The vision is that manufacturers that produce drugs that could pose risk to health or well-being, or drugs requiring many complex processes, should be more frequently inspected than other "less risky" drugs.
But which type of facility might be more prone to complacency, cutting corners, or other non-GMP practices? What of the inspectors conduct? Are they all equally possessed of good judgement and equally conscientious? Are we going to have problems similar to those created by bank regulators who failed to regulate in the period leading up to the Financial Crisis?
It might seem there are several kinds of "risk" to be considered with this proposal.
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US FDA to take risk-based approach to biomanufacturing inspections
26-Jan-2018 By Dan Stanton
A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the US FDA says.
www.in-pharmatechnologist.com/Headlines/Regulatory-Safety/US-FDA-to-take-risk-based-approach-to-biomanufacturing-inspections
But which type of facility might be more prone to complacency, cutting corners, or other non-GMP practices? What of the inspectors conduct? Are they all equally possessed of good judgement and equally conscientious? Are we going to have problems similar to those created by bank regulators who failed to regulate in the period leading up to the Financial Crisis?
It might seem there are several kinds of "risk" to be considered with this proposal.
This content is copyright protected
However, if you would like to share the information in this article, you may use the headline, summary and link below:
US FDA to take risk-based approach to biomanufacturing inspections
26-Jan-2018 By Dan Stanton
A risk-based approach to inspection regulations could result in increased audits of more complex manufacturing sites, the US FDA says.
www.in-pharmatechnologist.com/Headlines/Regulatory-Safety/US-FDA-to-take-risk-based-approach-to-biomanufacturing-inspections