There is a new US Food and Drug Administration (FDA) Commissioner who wants a "strong" FDA and she is backing her words with action by initiating a programme that cuts the time that firms must respond to 483 observations from 30 to 15 business days. Not only is the time halved but the response must also be complete! Be prepared to be compliant and remain compliant with regulations — or else.
There you are sitting at your desk browsing the latest copy of LCGC Europe wondering what the title of this column is all about. If you work in a regulated healthcare company that sells products to the USA or for a laboratory that works on behalf of these regulated companies you will know that FDA (Food and Drug Administration) inspectors inspect your company every so often. Occasionally an inspector may come into the chromatography laboratory and inspect the way that you work against the requirements of good manufacturing practice (GMP) or good laboratory practice (GLP). Prepare to be prepared when the FDA inspectors next pop in for tea and biscuits and a cosy chat. The FDA has changed its approach to inspections recently and chromatographers must understand the impact that this will have on your approach to regulatory compliance in the laboratory.
FDA Modernization Act 2009The FDA has not had good press over the last few years and has been on the receiving end of two critical reports from the Government Audit Office (GAO). The last report covered the FDA foreign inspection programme1 and was damning in the fact that the FDA don't know how many establishments it has to inspect, relies on volunteers to inspect overseas and when they do conduct inspections the frequency is lower than in the US.
As a result of this report — and the increased threat of supply chain contamination — the FDA Modernization Act 2009
is being passed into law and will involve:
Concomitantly there has also been an increase in budget to fund this and increase the inspection programme.
So what does that mean for me in the chromatography laboratory? This stuff appears to be too high a level to even contemplate doing anything about. Well what this means is that with an increase in budget and the fact that FDA are opening offices in Europe your companies will be seeing the inspectors on a far more frequent rate than before.
New FDA Commissioner Acts
In addition to the Act, there has also been a change at the top of the FDA with the appointment of Dr Margaret Hamburg as the new Commissioner in May 2009. On 6 August the new Commissioner made a speech that emphasized the need for a "strong FDA", which highlighted the benefits of this new approach as having credibility with the public, being transparent in explaining its decisions, able to enforce the law and being creative in promoting health. In this speech with an accompanying video,3 the following quotations were included: