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November 02, 2022
Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.
October 18, 2022
In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.
October 02, 2022
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
September 07, 2022
A new survey has demonstrated that remote audits, brought to the fore thanks to COVID-19, are not necessarily a preferred option for clients.
A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
Innovation is driven through a strong digital backbone.
An integrated approach to the data lifecycle is key to successful digital transformation.
September 02, 2022
The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
September 01, 2022
A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.