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Pharmaceutical Manufacturing and Packing Sourcer

A Stabilised Position

Sarah Gash at Bodycote Cirrus (part of Bodycote Health Sciences), investigates why outsourcing stability testing and storage makes sound business sense

Today, outsourcing parts 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 inhouse to outsourcing of any work, in the longer term it makes good business sense – especially 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 volumes are increasing, and where 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.

QUALITY ISSUES

Deciding 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 a 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 have an 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. Using reliable partners to cover peaks of work helps get the product through the development process much more quickly.

Outsourcing Can be Cheaper
Stability storage and protocol testing is expensive and timeconsuming. 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 costefficient business model as a result.


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A Chemistry graduate from the University of Birmingham, Sarah Gash has more than 14 years’ experience in a wide range of analytical roles within the pharmaceutical service industry. She has a thorough understanding of analytical method transfer and method validation for a variety of formulated pharmaceutical products, combined with expertise in many analytical techniques. Sarah has written and overseen report generation for regulatory submission for top 10 pharmaceutical companies, as well as smaller concerns. Having worked in the pharmaceutical sector throughout her career, Sarah has been involved in numerous audits, including ones by the FDA and MHRA, resulting in approval for the site.
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