“The quality system is the responsibility of the organisation’s management and requires their leadership and active participation and should be supported by staff commitment” states EU GDP 2013/C 343/01 in Ch. 1, subsection 1.

An ongoing problem…

As the UK’s leading good distribution practice consultancy for full-service remediation of IAG/CMT cases and licence terminations (and ISO 9001: 2015 accredited for “Training and Quality Management Consultancy for the Pharmaceutical Industry”), Paradigm Shift Consulting frequently find that senior management often do not know their own responsibilities, and part of the initial remediation or onboarding process is “managing upwards” to let them know their regulatory and legal responsibilities.

The Human Medicines Regulations 2012 (as amended), states very clearly the obligations of the licence holder and the requirements as to responsible persons. 

However we still encounter companies whose senior management have little or no GDP awareness training or licence holder training, and subsequently their quality teams are either frustrated and feel unsupported, or (and possibly worse, and potentially terminal for the business) are allowed to systematically fail without any real management oversight.

A knock-on effect

It is typical that a Responsible Person receiving a critical deficiency will automatically elicit a further critical for the licence holders, typically worded as follows;

“The licence holder failed to ensure that a Responsible Person who, in the opinion of the Licensing Authority, had adequate experience and knowledge of the activities to be carried out under the licence.”

An “easy” two criticals and a trip to the Inspection Action Group!

How can you defend against something similar?

Simple: GDP Compliance. All the time.

10 years on, and the gloves are off… there are no more excuses about why you have failed to ensure that suitable temperature control of ambient or cold chain shipments is happening. You cannot say “I didn’t know” without digging a deeper hole. Ignorance of the law or guidance is no saving grace!

“We cannot afford it…”

“We tried our hardest…”

“We assumed…”

“We hoped…”

Getting involved

So… how can you, as a senior manager, be more involved in your QMS?

1) Play an active part in quality and improvement meetings – or at least read and sign off the documents, evidencing you have seen it.

2) Review the self-inspection reports – read and sign them off, ask questions and feedback.

3) Active participation in management review meetings (Chapter 1, subsection 1.4) and yes… sign them off.

4) Keep your teams advised on potential changes AHEAD of time, so they can support and assess risks. Anything confidential can be built outside the QMS initially, but a contemporaneous change must be documented ahead of time.

5) Ensure that your Responsible Person has suitable knowledge and experience – difficult to do, especially if your GDP is weak. We can help with online assessments or training, or an external audit or supported self-inspection and train your team at the same time.

6) Attend GDP audits and MHRA inspections – more than just opening and closing meetings, stick your head in and see how things are going, potentially be in there for the day, supporting your RP and chipping in with useful commentary… no jokes about poor compliance, or quality being “sales prevention” please!

7) Have suitable training – but what is “suitable”? We run a one day intensive GDP, condensed from two days, to give a good overview of what is expected over all 10 working chapters, and we have Licence Holder training available that also covers third party management and the responsibilities of the RP available on www.gdptraining.co.uk

8) Ensure that you are supporting the QMS – with sufficient competent personnel, suitable facilities and appropriate resources… quality in, quality out.

9) Back to the floor days – ideal for all personnel, however senior managers should understand how their business is running, what the departments do, what the struggles are. Also spend time with the RP to see what their job “looks like.” You could also/alternatively interview staff or have an ideas box, and really understand what their problems are.

10) Attend the MHRA Symposia, or even better the UK GDP Association event virtually or in person – It’s a great networking event and also gives you the opportunity to meet others, make contact with suppliers and providers or potential customers, and see what’s coming next.

Common Sense

It is clear that the cost of a good QMS is not much more than a bad one, until you get regulated, or you have a critical incident and lose a large shipment of product, so do not be a passenger in your QMS, take action and LEAD.

To my frustrated colleagues in quality: Please do pass this on to your Senior Managers and remind them that there is a potential for the Licence Holder (often the board of directors) to have up to 2 years in prison under the Human Medicines Regulations, in extreme circumstances.

It has been said “You don’t need to be a mechanic to drive the car” which may be the case, but you do need to know how the car works, that your car needs to be serviced appropriately, cleaned, MOT’d and whoever is driving that car may lead you to a horrific and expensive crash, potentially leading to the suspension or revocation of your licence.

Training and Information

Do you want to know more? Do you or your staff need training? Struggling to get the senior team to understand their role? Contact us for a free, no-obligation chat on 0330 133 0920. Alternatively, you can send us a direct message via the contact form below.

Also, you can use the link button to visit the courses page.

Welcome to a new paradigm!