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
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
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
"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."