Get ready for inspection
pharmafile | December 13, 2007 | Feature | Research and Development | MHRA, inspection, reg affairs
No one looks forward to receiving a letter from the MHRA (Medicines and Healthcare products Regulatory Agency) inspectorate announcing their intention to make a routine inspection. However, careful preparation can pave the way to trouble-free progress.
The MHRA directly licenses all new medicines for use in the UK. Organisations and companies that are involved in the process such as contract organisations and non-specialist groups (for example, those involved in the transport of medicines), are not licensed by the MHRA, but they are regulated.
This includes organisations such as Melbourn Scientific, a contract analytical services provider, as Managing Director Steve Westcott explains: "Melbourn Scientific is part of this process in that we perform the testing and generate the data by which medicinal products and devices can gain a licence. We are inspected on a rolling two-year programme and are required to maintain the high standards expected by the MHRA at all times."
Value of inspections
Steve sees a real benefit in the way that the UK regulates the pharma industry. The MHRA's stringent quality standards are globally respected and, as a result, data produced by the companies it inspects are widely accepted. This type of endorsement is invaluable for companies with many international clients.
These quality systems cannot be applied retrospectively and, therefore, if an organisation tries to take the 'easy' route and use a lesser system, it can be catastrophic when they eventually have something to show for their labours.
"For companies such as Melbourn Scientific, it is important that our data have integrity and, therefore, acceptability. Due to the excellent reputation that the MHRA rightly enjoys globally, our data are widely accepted."
Because of the type of testing provided, Melbourn is subject to inspection under both GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) to provide quality assurance of procedures. In addition, the company is also regularly inspected by the FDA where the inspections are product driven.
Steve advises that the best way to consider the inspections is as an audit of internal procedures from the management downwards. Organisations should be ready to deal with an inspection at short notice.
"Although you normally have about 10 days notice of an inspection, this is a courtesy as the MHRA does have right of access. 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.
Be prepared
Regularly being inspected by clients, as well as the regulatory bodies, has given Steve a number of insights.
Although the company self-inspection regime should ensure the company is in a state of inspection readiness, it is worth making an additional check before the inspection.
"Walk around the building and check notice-boards and rest areas. The inspectors have an innate ability to pick up the one item of equipment, the one procedure, the one area where the cleanliness is not up to scratch. It is worth trying to pre-empt this, but I am afraid it is almost inevitable.
"The members of staff who are interviewed will have to show evidence of their training, so it is a good plan to make sure everyone reviews their records to ensure these are up to date with recent training and qualifications.
"It may also be worth doing some mock interviews with newer staff who may be unfamiliar with the type of intense questioning that is used in an interview."
On the day
"Getting the day off to a good start is important we try to 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 he or she thinks that you are trying to hijack the day so resist the temptation to be too helpful.
The inspector will require somewhere to work, so set aside an interview area and possibly a separate area to prepare any documents that are requested during the inspection.
"Also, make sure that all the people that the inspectors may want to talk to are available. This may involve management at all levels.
"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.
"In our experience, the inspectors are generally friendly and personable and will take this feedback in the way it is intended."
Putting recommendations into practice
At the end of the inspection there will be a closing out discussion. If management representatives have not been with the inspection throughout the day, they will need to be present at this point. This is an extremely important meeting at which any failings will be categorised and itemised.
"The inspection will result in a 'general compliance' report with findings that are classified into three categories. There are usually three categories, the names of which will change over the years. Suffice it to say, you do not want any findings in the top 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. Steve recommends that if this timescale proves problematic, 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. You don't want contradictions, therefore, some of the apparently simple fixes can become quite involved.
In conclusion, it is important not to lose sight of the objective of the inspection – to ensure the safety of medicines. It is very easy in the stress of preparation to take comments and observations as personal criticism and it is best to be alert to this in your staff who can feel that they have fallen short, and become defensive when receiving this type of feedback.
"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."
Box: Top tips for an inspection
Create a good first impression by assembling the information file before the inspection with great care and presenting it professionally
Establish a good relationship with the lead inspector at the start of the visit
Prepare staff for the inspection: consider mock interviews; ensure training records are up to date
Ensure that all documentation is in order and available
Organise a 'back room' with appropriate staff to assemble the document requests during the visit
Walk through the site before the visit to check all is in order
Note the comments made by inspectors during their tour of the facilities and during the closeout meeting
Hold briefing meetings for key staff at the end of each day of the visit, to exchange notes on progress so far
Start working immediately on answers to the findings outlined at the closeout meeting
Don't lose sight of the purpose of the inspection and use the findings to improve your organisation.
For more information on Melbourn Scientific contact Business Development Director Mark Hammond on tel: 01763 261648, e-mail: Mark.Hammond@melbournscientific.com or visit www.melbournscientific.com
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