EU guidelines revised in 2013 set out best-practice methods for how medicines and other pharmaceutical products should be stored, transported and handled. These Good Distribution Practice (GDP) guidelines have gained real traction, and the regulator, MHRA, is putting more and more pressure on businesses to ensure they're compliant.
Qualsys recently partnered with long-standing GDP consultants PJH Logistics Solutions. PJH have years of expertise in helping a wide range of businesses – from global pharmaceutical giants to regional transport firms – to understand and adapt to GDP.
We spoke to Pelleren Hodges, PJH's owner and director, about the benefits of enlisting a consultant, and why any company required to meet GDP should consider doing so.
Vast knowledge of what GDP involves
GDP is no different to many other quality standards and guidelines in that it's complex to interpret and often difficult to implement. It might be new to you, but a GDP consultant has been down that road many times before.
"Most of what we do revolves around GDP, particularly in relation to the pharmaceutical business," Pelleren says. "Part of it is sub-contracting for other consultancy firms, and the other part is direct work with our own clients.
"It could be a project to get a company up and running in applying for a Wholesale Distribution Authorisation (WDA). It could be a pre-inspection audit or a customer inspection. We might act as Responsible Persons for WDA licences, or set up quality management systems. Our work is extensive."
Experience of implementing quality management systems (QMS)
Complying with GDP means taking a consistent, organised, systematic approach. There's no better way to do this than by implementing a QMS throughout your business. A GDP consultant will know how that implementation process should unfold, and consider questions like:
- What kind of product do you provide?
- Do you store the product yourself or do you outsource it to someone else?
- Are your suppliers complying with what you want them to do?
- What are your premises like? What equipment do you use?
"Gathering this kind of information means we can start to form the structure of what the QMS will look like," Pelleren says. "We can then draft the documentation, fine-tune it and get it approved by the necessary people within the company. Then we can provide general and more detailed procedural GDP training with all the staff who are going to be involved in GDP activity."
Understanding of how quality management software can help
Quality management can be made simpler and much more effective with the use of software. A GDP consultant will understand the part software can play in strengthening an organisation's QMS.
"Software is crucial, particularly when it comes to maintaining an audit trail, for example," says Pelleren. "It makes the task so difficult when you have bits of paper flying around, some of it's lost and it's impossible to track.
"We work with a lot of smaller companies, some of which don't employ a quality assurance person. They might assign that responsibility to two or three different people, which can cause difficulties in terms of who's doing what, when and how. So a software package such as EQMS gives us the tools to manage that."
Experience of dealing with all levels of staff and getting leadership buy-in
Complying with any sort of regulation or standard, implementing a quality management system – these can be initially disruptive to a business that's traditionally operated with a very fixed mindset. Changing a company culture can unsettle and attract resistance from employees at all levels. A GDP consultant will be familiar with this and have the skills to persuade people to buy in to the new ways of working.
"Some companies do see getting a WDA as a tick-box exercise, and once they have it, that's it," Pelleren says. "It could be that the senior managers have been told they have to do it, and even then it's only lip service. For us, it's about understanding that and tackling it.
"We'll look to provide the right metrics so that the very top manager in the business knows they're responsible for ensuring the managers below them hit their targets. They're the targets that MHRA will be looking for in their inspections.
"Other companies are more willing but pharmaceuticals might not be their core activity. So in those cases, we need to account for the staff not having that familiarity with GDP and getting that continual experience of handling it."
Are you a consultancy firm?
Michael Ord, New Business and Marketing Director, says: "Here at Qualsys we work to a set of core values centred around the idea of making other businesses fitter, faster and stronger. When we form partnerships we always look for organisations who share those values.
"It was clear right away that PJH Logistics Solutions believe in the same ideas, and then some, and we're delighted to partner with them to benefit both our customers and theirs."
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