Sarah Gash, general manager of Bodycote Cirrus, reviews how to get the best out of outsourcing stability testing and storage
Today outsourcing at least part of the analytical laboratory or manufacturing requirements to an independent laboratory is normal practice for most pharmaceutical companies both large and small. While there is often inertia when changing from in-house to outsourcing of any work, in the longer term, it makes good business sense and this is usually the deciding point.
With the rise of virtual pharmaceutical companies, it is perfectly possible to outsource almost everything and still deliver a quality product. Although companies worry that the risk to confidentiality and quality assurance may be increased, it is possible to manage this sensibly. Stability storage and testing is one area of work where the volumes are increasing and it makes excellent sense to outsource. Outsourcing basic tasks such as stability testing can free-up scientists to work on projects that will reap a better return, as well as resulting in more effective use of in-house lab space.
Deciding on whether to outsource stability testing and indeed which laboratory to choose involves looking at quality issues (especially in pharmaceutical analysis), service levels and monetary value (the price versus benefits to the business).
So what makes stability testing and storage such an ideal area of business to outsource to an independent laboratory? And what distinguishes 'stability' from other testing which could potentially be outsourced?
Outsourcing doesn't hold up product delivery:
The reason is that stability studies for finished product merely support the supply chain; they do not stop a product being loaded onto a lorry for market. This means that analysis does not impact upon the delivery of product to market, an essential for every commercial pharmaceutical manufacturer.
Outsourcing helps quicken the development process:
For r&d stability, there are often huge peaks and troughs in workload. With the urgent need to get the work done, it doesn't necessarily make sense to carry all this resource in-house and using reliable partners to cover peaks of work helps get the product through the development process quicker.
Outsourcing can be cheaper:
Stability Storage and Protocol testing is expensive and time consuming. When a manufacturer actually takes all its costs into account, it can often be cheaper to outsource to a specialist provider who can spread costs across various contracts. Outsourcing reduces costs because outside contractors focus on the specific services they provide and maintain a more cost-efficient business model as a result.
By choosing the right laboratory to manage stability protocols and testing, manufacturers can ensure that the analysis is completed within the required timeframe to the required quality standard. Manufacturers can also use the expertise of the laboratory team to obtain feedback on the latest changes in legislation and any updates required to existing methods.
Manufacturers can save the time their analysts spend on stability management and reallocate them more pressing work. Or it may be that they simply require a back-up facility to store the trial at the same conditions for emergency planning on a crucial product.
Having decided to outsource, searching for the right kind of laboratory to suit a company's needs is next step and can be like looking for a needle in a hay-stack!
First it is important to consider the 'scope' of the contract lab:
- Does it carry out the services required? There are a few contract research organisations that offer a full range of service from pharmaceutical development to finished product, while others may have an expertise in a particular technique. You may want a full service provider, a broad analytical laboratory or a niche service provider. Be sure the lab really does have the capability you require and understand the quality implications.
- Does it operate in the right geographical area? More and more large pharmaceutical companies are seeking laboratories with a global capability allowing regional or global contracts to be managed by approved suppliers. Choosing a laboratory group, such as Bodycote Testing, means additional resource in more than one country, which, as well as providing emergency back-up, can be vital when testing turn-around needs to be fast or additional resources are required.
- Does it offer the skills and capacity required? A detailed audit of the lab's capability should be undertaken. Is the equipment sufficient for the project? As well as looking at the basics such as the company's business track record, and scientific expertise, it is important to also consider the lab's responsiveness and flexibility to changes in demand.
- Does it work to the right quality and service levels? Can your team work effectively with theirs? Audit the Quality System to ensure it meets requirements. Check whether the laboratory has a sound service record? If in doubt, ask for good references from other companies with which the contract lab deals.
- Outsourcing isn't just about sending out some batch testing, but about building a long-term relationship built on the key ingredients of quality, service, knowledge, culture and cost. It is important to consider how these ingredients can all impact on the overall cost of the project.
When outsourcing long-term projects such as stability testing, it is important to look at the total cost of ownership to realistically predict how much the project will cost overall. Beware of low upfront costs that may hide higher costs later on and don't dwell on the headline cost.
- How much time it will take in-house staff to manage the contract laboratory and will all staff be able to work well as a team? When choosing a contract laboratory for outsourcing, look for a company that is suitably qualified and committed to teamwork.
- There may be out of specification results and analytical errors. How will the contract laboratory team deal with these issues if they arise? If a company can rely on the laboratory to handle these properly within a robust quality management system, it will reduce the management resource that needs to be allocated.
- Does the laboratory understand the business in order to predict problems in advance and does it have the knowledge to give suggestions on how such problems could be solved? Specific industry experience is a good indicator of this.
- Can the contract laboratory provide a flexible response when issues outside of the contract arise? Good service is key and in most cases long-term relationships are built as a result of this. It can take a long time to change suppliers so time and money invested at the outset to establish a relationship built on good service can pay dividends. Take references if possible and although it is subjective, also consider whether the laboratory personnel inspire confidence.
Auditing the laboratory and speaking to both the people who will actually be handling your business and those who will be making the key decisions is an important element of the process. Manufacturers should feel confident that both management and bench analysts could do the job effectively.
For complex projects, ongoing communication and working in partnership is vital. Although from an internal resource viewpoint it should be minimised, face-to-face meetings with the project team plus telephone and email updates are essential. In time developing relationships between client and contract laboratory will build understanding that will be the best strategy for the most effective collaboration.
At a higher level, always remember to keep control, starting with a sound quality agreement, aligned with an audit team to ensure that targets and agreements are being met.
In reality finding a perfect contract laboratory to exactly meet a manufacturer's needs is quite a challenge. But, by thinking about the real needs in terms of resources and total cost, manufacturers are more likely to achieve positive results all round.