New help for UK drug makers to pass FDA inspection
pharmaceutical and medical device manufacturers prepare themselves
for a plant inspection by the US Food and Drug Administration
(FDA).
FDA inspections frequently expose manufacturer shortcomings as the cause of production failures and the instigation of corrective actions. FDA records also show that there are problems with up to half of the corrective and preventative actions taken by manufacturers.
"These are issues that manufacturers need to get to grips with," said RSSL spokesperson, Andy Martin.
"The FDA especially has shown itself to be on the alert for substandard or inadequate mechanisms for correcting failures and companies continue to receive adverse comment on how these events are followed up, despite there being systems that are easy to learn and implement, which will satisfy the inspectors."
The courses will run for the first time this summer and are aimed at helping manufacturers operating in the UK identify and address these issues.
The two-day "Preparing for a Regulatory Inspection" course is aimed at pharma professionals who wish to increase their understanding of the mechanics and dynamics of the inspections process.
It covers differences in practice and behaviour between various pharmaceutical regulatory inspectors (such as US vs EU) and sets the ground rules for a successful inspection, said the company.
The two-day "Failure Investigation and Routine Cause Analysis" course is designed for those who want to gain more specialist advice and increase their understanding of a failure system and how to design one that enables regulatory expectations to be met.
The third course on offer, "Corrective and Preventative Action" is covered in a one-day and will demonstrates the mechanics of a systematic investigation process and show how the outcomes can be used to ensure effective correction and/or prevention of the reoccurrence of failure.
