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Facilitating the audit process

External auditing of suppliers is a time consuming exercise, but there are ways to ease the process. A Veteran of over 500 audits, Mike Parker of Brecon Pharmaceuticals*, explains how

External audits are an expensive business, both for the auditing company and the supplier or contractor under scrutiny. The time involved in preparation, the audit itself, subsequent questions and clarifications and, for the auditing company, the writing up of the report, is not inconsiderable.

Even for a small facility, the hours involved for the total process will tie up the personnel involved for upwards of three days and for larger sites it could be considerably longer. Times this by the number of suppliers a typical pharmaceutical house has – plus the number of internal audits carried out – and it comes as no surprise that large pharmaceutical houses have teams of dedicated auditors and even small concerns will have some staff seriously distracted from their “real jobs” by the auditing process.

Of course, these personnel are carrying out a vital role in ensuring that those supplying goods and services to the company are of a standard. Their role in maintaining internal procedures will also reflect positively on the quality of their end products.

This, in itself more than justifies their cost to the business and over time it is likely they will save the company considerable sums by helping to avoid the repercussions associated with, for example, reject products, late deliveries, or even recalls.

So while audit teams may not be considered a direct contributor to the bottom line, they can be instrumental in maintaining it and in some circumstances, preventing it getting badly dented. Nonetheless, the fact cannot be avoided that audits represent a considerable cost to businesses and it is in the interest of both the auditing company and the audited supplier to make the process as efficient as possible in terms of both time and effectiveness.

Obviously, there are no tablets of stone, as the concept of a “standard” audit is by and large a misnomer. A number of variables – not least the nature of the job the third party is carrying out – will ensure that each audit is likely to be unique in some way. However, there are predictable elements of every audit which can be pre-planned and basic tenets which can be followed which will make the process more efficient.



The following is particularly applicable when auditing suppliers of contract services, but it also has relevance to those looking at component and material suppliers. Some of the points made may appear obvious, but often it is the simplest of things which cause misinterpretations and delays.

Firstly, it is frequently the case that certain information – from both sides – can be supplied ahead of audit day so pre-preparation is maximised and any questions or required clarifications can be properly considered. Information that is not pre-supplied should be readily at hand on audit day. It is therefore useful to make the company to be audited aware of your requirements.

For example, you will want to discuss the organogram of the company structure to assure yourself that the potential supplier has the required skill-sets and procedures to cope with the demands of the contract. Similarly, you will need to see all relevant SOPs.

A word to the wise here too. Please do not be tempted to apply your own SOPs to a third party’s operation. Contractors will have aspects of their SOPs that can be modified, within limits, to incorporate particular needs – say with differing limits on reconciliation for bulk product – but it is not recommended that you insist on changing them entirely to dovetail with your own internal procedures as the operational personnel’s unfamiliarity with them could lead to difficulties.

It may help to reassure you if you remember that most contractor’s SOPs have been developed over a long period and are the result of hundreds of audits which equates to months’ worth of “free” consultancy. They have been diligently scrutinised by both commercial and government agency auditors from around the world and adjusted appropriately – they are effectively as good as you get.

It is also important to ensure that all the personnel who are key to the project on the contractor’s side are available during the period of the visit, as it may be that questions will arise that only they can answer. However, if you make this request, try not to make a habit of changing the date of the audit as this will obviously cause friction with the contractor who may have rescheduled the diaries of various senior personnel to comply with your demands.

There are also a number of things you can do to ease the process and save everybody time. You have presumably checked the company’s accreditations and testimonials and seen its work, so the basis of your visit should be co-operative rather than confrontational. As such the audit should not be treated strictly as an exam, but more as an investigation to ascertain whether, with the necessary input from you, the contractor can provide the right quality product within the specified time schedule. If the audit is successful a number of variables may then come into play when negotiating the contract.

It is important that the contractor knows exactly what the job entails so that they can be confident they can meet your needs (It may appear very obvious, but those carrying out the audit on the day should also be fully briefed on the requirements).

For example, it helps if the contractor knows if they will be required to supply materials and components and who will apply controls to these items. Other areas to consider include the type and design of the pack, especially if it is an unusual format which may need specialist forming or handling. The nature of the labelling and language requirements should also be disclosed to ensure they can comply with your needs.

Most contractors will also be able source analytical services if you required them to, but it is worth checking that they have the experience and contacts to fulfil this need. Similarly, if you want the contractor to handle final release, make sure they are happy to take on this responsibility.

It is useful too if the audit plan is supplied prior to the site visit so that the contractor can carry out some preparatory planning for specific issues that may arise. This is not a case of “making it easy” for the contractor, it is a way of ensuring they are as best prepared as they can be to respond to your requests.

Indeed, the more pre-knowledge a prospective contractor has about the job, the more relevant and effective the audit will be. Moreover, should the contractor be awarded the project, less discussion and planning will be needed at a later stage when time will undoubtedly be more pressing.

In order to process this information in as quick and clear a way as possible, it is also vital that both sides establish firm channels of communication for both commercial and technical information.

It may also be pertinent to contact colleagues ahead of the audit to check if the company to be visited is being considered for any other contracts, in which case you could save a re-visit by covering specific points they may wish to be raised.

As mentioned, at the audit itself, adopt a positive attitude towards your prospective partner and the day will run much more smoothly without altering the result. If things are not what they should be, it will soon become apparent anyway and if everything is up to spec, you will not have put a potential strain on the relationship. How the company applies standards can be gauged by close observation of operatives and procedures during the visit. Conversing with staff at all levels is also useful to gain an insight into the company’s philosophy and modus operandi.

The most crucial part of any audit is the summary session – if there are any concerns from any party, they must come up at this point. All facts should be agreed at this session before the report is written-up and as a final measure to ensure it is a true account, the report should be sent to the audited company for checking before it is finalised.

This should not engender a debate unless the contractor believes there are blatant errors in the findings. The primary reason for this exercise is simply that factual inaccuracies do find their way into reports. These may be down to simple misinterpretations on the auditor’s behalf, or poor communication from the audited company. Whatever, it makes sense to avoid embarrassment all round by passing it in front of the eyes of all senior personnel involved.

This co-operation in getting a true and correct result should reflect the overall manner in which the relationship between client and contractor is conducted, as there is an inevitable link between the nature of this relationship and the degree of success of the project.

The more information exchanged and the more the client takes the contractor into their confidence, the better the result will be. By fostering a “partnership” approach, the contractor will accept a degree of ownership of the project which ensures a high level of service and, if required, innovation. Indeed, given the right brief, we find we can often provide added value way beyond the simple fulfilment of the contract through application of the experience and expertise we have gained over the years.

So what of the future of audits? The most glaringly obvious fact about current practice is the duplication. Every major pharmaceutical company in the world and numerous middle-sized and small concerns, have passed through Brecon’s doors, all basically to check the same equipment, procedures and general competency.

A central database of approved contractors held and monitored by an industry body or government agency and backed up by the agreed use of testimonials and references would seem to make perfect sense. The funding of such a body would only represent a fraction of that spent by drug houses annually on external audits.

Of course, audits can have differing emphases, or be very product specific and if the database does not hold the required information, individual audits could still be carried out. New audits and re-audits at specific intervals would also continue, but the total number would be radically reduced which would ultimately cut the time to market for many products, a crucial factor nowadays for most companies.



To rationalise the audit process itself and to ensure a full and frank exchange of information between the parties, standard – though flexible – pre-audit questionnaires could also be compiled. One would be completed by the contractor to save time at audit and the other by the client to ensure the audit is as relevant as possible.

For the nearer future though, I believe the industry will increasingly move away from the traditional sponsor/contractor relationship and the trend towards constructing partnerships and even co-sponsorships will strengthen, which will inevitably change the nature of the audit process for the better.

Top ten tips for an effective audit
  • Make the contractor aware of your full information needs pre-audit
  • Get as much information as possible supplied prior to audit
  • Inform colleagues of the audit as it could save a re-visit
  • Supply a full job specification and audit plan in advance
  • Ensure all the contractor’s key staff are on-site on the day
  • Determine responsibilities of each party at an early stage
  • Establish firm channels of communication
  • Adopt a partnership approach to maximise contractor’s commitment
  • Ensure all concerns and questions are aired at summary session
  • Give the contractor sight of the report before finalising it



  • This feature first appeared in the Spring 2002 issue of PMPS magazine


    Service providers -
    partners in prime

    Today's pharmaceutical services companies face the most challenging of tasks, as they are required to offer speed, flexibility and competitive pricing combined with impeccable standards. Yet, says Steve Kemp, this ideal can be achieved when a partnership approach is adopted

    The rash of mergers and acquisitions over the past decade has transformed the research-based pharmaceutical sector. Almost without exception, the top companies in the sector are shedding 'non-core' functions such as manufacture and packaging, as a diverse range of operations is increasingly viewed as a hindrance rather than an asset in today's aggressive global market.

    Traditionally, large companies existed to reduce transaction costs - that is, to retain the profit generated by each stage of product development, manufacture and sale. However, current business models suggest that focussing on core competencies is more desirable, and with improved communications and the globalisation of the economy, it is easier to identify the most suitable suppliers and the best prices for services on the open market. The attraction of variable rather than fixed costs is also considerable.

    Many mergers and acquisitions have been justified on the basis of aggressive sales forecasts, which can only be achieved if companies are able to increase the number of new drugs coming out of their pipelines. Several of the world's top-selling drugs will come off patent in the next few years and these must be replaced by New Chemical Entities (NCEs) if revenue streams are to be maintained and increased. Most companies in this sector now have a clear strategy to focus on their core competencies of drug development and marketing, pledging publicly to increase the amount of sales revenue they spend on R&D; and to cut typical time to market for NCEs by as much as 30%.

    These are ambitious targets indeed but in the context of the average of £350m development costs for each NCE and £1m sales revenue each day during patent protection, they are understandable enough.

    With drug companies avowedly focussing on the beginning and the end of the product cycle, a wide range of services once performed by full- time employees is now outsourced. Estimated at £13bn in 1998, the pharmaceutical outsourcing market continues to grow at some 20% p.a.

    Outsourcing creates access to expertise and production capacity and can be a major factor in reducing time to market for a new product. It also allows pharmaceutical companies to be fast and flexible, while avoiding the financial risk associated with investment in facilities and personnel. It is attractive because it provides the flexibility required, whatever the degree of success achieved by the product in question.

    Providers of outsourced services take many and varied forms but they must all offer in common speed and flexibility of response. The degree of regulatory control applicable to the production of pharmaceutical products, however, means that no corners must be cut, whatever the pressure to offer flexibility and fast turnaround combined with a competitive price.

    The nature and extent of outsourcing also varies widely from company to company and from product to product. The linchpin of many such arrangements is the contract research organisation (CRO). Established initially to take drugs through the clinical trials procedure, many CROs have now expanded the range of services they offer, with some now moving into early stage R&D;, while others are offering production, packaging or sales and marketing services. Others in turn contract out requirements such as the preparation of packs for clinical trials to companies with expertise in this area.

    The growth in the outsourcing sector and the increased range of services it offers is engendering a new spirit of partnership with the pharmaceutical industry.

    In common with most companies in the field, Brecon Pharmaceuticals has experienced significant changes in the past decade. A decade ago, outsourcing was generally viewed as something of an emergency measure, and certainly not a long-term option. Over the years this perception has changed and ongoing partnerships are now more the rule than the exception. Teamwork has replaced the old approach of simply handing over aspects of research, manufacture or packaging and naming a date by which the finished product must be delivered.

    For example, on the packaging side, many pharmaceutical companies use contract houses as an extension of their in-house facilities. As order patterns become less predictable, these companies can remain efficient and competitive by outsourcing small orders and those requiring rapid turnaround, for which their in-house facilities are not always appropriate.

    Most recently, the emergence of 'virtual' pharmaceutical companies, established for the sole purpose of drug discovery, has given a further boost to the sector. These companies require production on demand, with no overhead for production and packing facilities or personnel.

    Selecting the right service provider is a lengthy and complex process - each company and each project has different criteria. However, there are certain requirements which are common to all and which should be addressed at the earliest stage of discussion.

    • Can the supplier demonstrate experience relevant to the project in hand?
    • Does the company have a track record of delivering on time and to the agreed specification?
    • Can it provide the required degree of flexibility, in terms of availability of suitably qualified personnel and relevant equipment?
    • Is it accredited by all the authorities appropriate to the project?

    The level of expertise available in service companies is typically extremely high, as most tend to focus on a specific area of the supply chain. Moreover, established companies will have been audited many more times than their counterparts in the research-based pharmaceutical industry and be adaptable to the exigencies of their many different customers. Brecon, for example, has in the past developed a number of new services and facilities in direct response to customer requirements.

    It may also be true that as service companies rely exclusively on fulfilling specific tasks and, ideally, retaining clients, the levels of service and quality are often greater than those achieved in-house. In certain circumstances, particularly when a partnership approach is adopted, the service provider can add value way beyond the simple fulfilment of the contract through the application of their experience and expertise.

    A major contributing factor in the success of any such relationship is the degree of openness existing between the parties. A key aspect here is the audit process, conducted before any work commences. The more information provided by the Contract Giver at the audit stage, the better the Contract Acceptor will be able to perform, if and when an order is forthcoming. Many contract projects are undertaken in pressure situations, so time is of the essence.

    Auditors should also be briefed by their employers on the precise nature of the project for which the potential supplier is being considered. A focused audit will produce much more satisfactory results for both parties than a non-specific one. Any perception of the audit as a negative process is now outdated: one the one hand, auditors should be looking to save their employer time and money by find a suitable supplier as quickly as possible, rather than seeking minor non-compliances. On the other, the potential supplier must view it as an opportunity to demonstrate the extent of his capabilities.

    Successful outsourcing reduces costs, improves flexibility and enlarges the pool of expertise available to the research-based pharmaceutical sector. As such, it is now generally part of a strategic plan rather than an emergency measure. And long-term business relationships are most fruitful when founded on mutual trust and confidence.

    First published in Manufacturing Chemist, September 2001



    Steve Kemp is Business Development Director of Brecon Pharmaceuticals

    email stevek@brecon-pharm.co.uk




    Service suppliers need the versatility to respond quickly to customer needs. Trained personnel and a range of flexible equipment are essential

    Providing supplies for Clinical Trials is complex and demanding



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