Contract research company Melbourn Scientific has successfully passed its first MHRA inspection (Medicines and Healthcare products Regulatory Agency) in its new laboratory
Steve Westcott, managing director warns that the MHRA gives very little warning of an inspection and advises that companies should view the inspection as a review of internal procedures from management downwards.
"Although you normally have about 10 days notice of an inspection this is a courtesy as the MHRA does have right of access", said Westcott.
"It is also not unusual for them to request documents ahead of the visit.
"As a result it is not possible to 'prepare' so the best way to view an inspection is as a means of validating internal systems and procedures".
The MHRA's stringent quality standards are globally respected and as a result data produced by the companies it inspects is widely accepted.
This type of endorsement is invaluable for companies such as Melbourn that have many international clients.
As a contract analytical services provider, Melbourn is subject to inspection under both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) that provide quality assurance of procedures, in addition the company has also been regularly inspected by the FDA where the inspections are product driven.
Regularly being inspected by clients as well as the regulatory bodies has given Westcott a number of insights.
"Getting the day off to a good start is important - we try and ensure there is a parking space reserved and that a senior member of the management team is available to host the inspection".
"However the inspector will want to lead the agenda and will get suspicious if they think that you are trying to hijack the day - so resist the temptation to be too helpful.
"The inspectors will always find something and walking with them is equivalent to showing your home to a prospective buyer - you see the lab with a fresh pair of eyes.
"It is best to make a mental note of issues even if the inspector doesn't comment as they might spot them next time.
"The inspection will result in a 'general compliance' report with findings that are classified into three categories.
"The top is critical and it is sufficed to say that you do not want any findings in this category.
"The others need to be addressed before the next inspection".
The inspector will write to the management representative citing the areas for improvement and the company has 28 days to respond with a programme of how these will be addressed.
Westcott recommends that if this timescale proves problematic that it is best to alert the inspectors to this.
"As with any quality system if you change things there can be ramifications for other parts of the system", said Westcott.
"You don't want contradictions therefore some of the apparently simple fixes can become quite involved.
"I think the best way of viewing an inspection is as having a highly qualified auditor on site.
"So, if possible get them to give you the benefit of their experience and this provides an invaluable objective insight into how to improve your systems".
