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 GCPj Vol. 5 Nov/Dec 1998

Interview with John Simpson

Director, Regulatory Compliance, Worldwide.
SmithKline Beecham Consumer Healthcare Research & Development

I recently telephoned John Simpson and proposed the idea of being interviewed for GCPj. Having worked with John before I was aware of his intensive work schedule and also the fact that he commuted weekly between his office in Weybridge, Surrey and his home in Harrogate. Naturally, I was expecting to plan the interview around his schedule. However true to style John replied:

'No problem! When suits you?  It should be fun.'

This response typifies John's approach to work. Nothing represents a problem to him, he is keen to work with others to develop a program that is acceptable to all and also he enjoys a laugh! I was already at ease and having chatted for half an hour or so I realised John had already given me plenty of material to start my article. That evening John emailed me his curriculum vitae and some information about his career history. This openness is another aspect of John's personality that has made his career in Regulatory Compliance so successful.

John joined SmithKline Beecham (SB) in 1996, the culmination of an impressive and varied career history working for some of the best companies in the industry including BASF, Boots-Celltech and Zeneca. His roles have been quite diverse including: Technical Services Representative for dyestuffs and textile chemical products; Quality Assurance and Regulatory Manager for DNA probe-based diagnostics and thin-film devices; International Quality Assurance Manager for a group of businesses with interests in Biopolymers, genetic fingerprinting, silage inoculants and health care intermediates.

At the time John joined SB Consumer Healthcare the focus of research and development was quickly moving from nutritional/cosmetic goods to medicinal products.

John's current duties at SB include the provision of GCP auditing and the assurance that internal systems meet all relevant regulatory requirements. He has a broad responsibility that involves managing both the UK and US consumer healthcare regulatory compliance groups. I was keen to know how John balanced the dual responsibility of meeting EU and USA regulatory requirements.

"Compliance in consumer healthcare R&D must be capable of focusing on any individual, relevant quality system; whether it's ISO 9000 or US Food GMP or EU pharmaceutical GCP. Being fixed on one system alone, or one market's requirements is not an option. So for me this is a single philosophy and that means it's not a multiple role and certainly not a dual one. In developing new products for the global market, the requirements for compliance are a synthesis of those imposed by all the countries in which the products will be sold. In the case of US vs. UK cGMP's then this means meeting all of both FDA and MCA requirements." "Compliance in consumer healthcare R&D must be capable of focusing on any individual, relevant quality system; whether it's ISO 9000 or US Food GMP or EU pharmaceutical GCP. Being fixed on one system alone, or one market's requirements is not an option. So for me this is a single philosophy and that means it's not a multiple role and certainly not a dual one. In developing new products for the global market, the requirements for compliance are a synthesis of those imposed by all the countries in which the products will be sold. In the case of US vs. UK cGMP's then this means meeting all of both FDA and MCA requirements." 

John has been working in the industry for over 30 years. He is therefore aware of the many changes that have occurred with the implementation and progression of GCP. I asked John what he regarded as the main benefits of GCP ?

"The advantages of cGCP are that the clinical program is carried out in a planned, controlled manner. The data generated are secure, traceable and support the conclusions of the clinical research. Other advantages are that the program is reviewed independently by an ethical committee and that the patients are informed of the details of the study in which they are involved. There are some product areas where the advantages of cGCP can be used, even where there is no regulatory requirement for them. The quality system elements addressed by cGCP can be addressed wherever trials of new products on people are done. This helps focus on issues and create an experimental program - and it's always a good idea to plan any experiment. I don't see any real disadvantages in cGCP and it's not an option to do without it for the development of medicines."

John has been lucky in that he has not encountered many problems introducing and developing GCP within SmithKline Beecham. The size of the Company means that there has always been adequate resource available for the task and senior management support has always been given.
"We were in pretty good shape on cGCP compliance and most of our effort has been in improvement rather than introduction. The implementation of ICH guidelines in the USA has been a major feature of recent work."

A key activity for John is ensuring that potential suppliers and contractors meet all relevant regulatory requirements. For this and other tasks John regularly uses external consultants. I asked him what benefits consultants bring to the organisation.

"Some of the advantages are that core headcount remains low, travel in large geographic areas such as the USA can be minimised. Consultants also bring a fresh view to issues, especially when used to evaluate home-grown systems. Also as they can be hired for specific tasks there is much more flexibility of effort in a situation where there are peaks of work."

However, John is also aware of the potential problems when hiring external assistance.

"A significant management effort is still needed to organise the consultant's work and evaluate their findings (one estimate is that this is equivalent to 30% of the consultant effort). They can also be expensive and it's difficult to evaluate the quality of their work before giving them a job. I've seen a couple of embarrassing situations where the consultant has audited from the wrong viewpoint and the internal department is left with insufficient specific information to feed back to the supplier who was audited. My current estimate is that not more than 1 in 5 consultants hired randomly, really fit well with the philosophy and aims of the organisation that hires them. Consultants also tend to be 'experts' and therefore they may come with pre-conceived ideas of how to do things and a reluctance to just 'turn handles'. Put these things together and the profile for a good consultant suggests they should be a good listener, a team player, and take time to understand company systems and what they are being hired for thoroughly before doing external work. If you get a good consultant, don't lose them."

For smaller organisations the initial costs of hiring external help may appear prohibitive, I was keen to find out John thoughts on the cost and cost/benefits of using consultants ?

"The cost of using consultants is, on the face of it, high. As for anything else, cost has to be balanced with benefit and sometimes you get what you pay for (and other times you don't). The flexibility element mentioned above is a large factor in making the cost/benefit calculation. For different work patterns there will be different optimal solutions. My advice would be to look at work patterns in the department, calculate the base level and if possible cover that by the efforts of permanent (or fixed term) staff, then use consultant effort to cover the peaks. I haven't found a reliable connection between what a consultant charges and the quality of their output, so caveat emptor."

Like many organisations the Regulatory Compliance Department of SmithKline Beecham have a key role in the provision of training. I know that this is an area that John takes a particularly keen interest. He is currently co-writing a book on Regulatory Compliance, he has co-presented training workshops and also teaches at the University of Teeside. I asked John how he approached the training aspect of GCP compliance within SB.

"I agree the compliance department has a crucial role in training on good practices. Elements of this include a brief introductory session on GxP as near as possible to the employee's start date, a core module on the relevant GxP (where possibly focused on specific job areas such as study monitoring etc), refresher training at declared intervals and senior management training on GxP. We also make the effective use of external speakers at planned GxP days and events."

Obviously John's role can not also be an easy one I asked him what he felt were the main difficulties he had experienced with regards to regulatory compliance?

"My main difficulties have always been in the area of influencing the compliance culture of organisations. If staff are not motivated to work in a compliant manner, then the best systems in the world are worth nothing. It's much easier to write an SOP than to change attitudes. I have seen several organisations change their culture and the crucial stimuli seem different. Sometimes it's because, having achieved a difficult goal after being cajoled and pushed, the organisation suddenly realises the benefits and no longer sees compliance as a burden. Sometimes it's because the core of promoters of compliance increases with new recruits and a critical mass then moves things on. Training is not the only element that influences organisational culture, but it helps, and that's why I believe compliance needs to be involved. The compliance department can only identify and advise on issues, it canít install compliance without the efforts of everyone. One thing is certain in all organisations, and that is that without serious senior management support, a non-compliant organisation will not progress to compliance."


 
 
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