When Outsourcing Goes Astray
“The best-laid schemes o’mice an’ men” often go awry – and that can apply to your outsourcing plans. What do you do if your contractor ends up in the regulators’ bad books?
Outsourcing is well entrenched in pharma’s business models and is a relationship that dates back to the very beginning of the pharma industry. Though some raw materials can be manufactured in house, the vast majority has always been purchased from third parties. And in the last 30 years there has been a surge in the use of outsourcing for all sorts of activities other than ingredients supply. Today, anything and everything can be outsourced including research, development, clinical trials, manufacturing, supply chain, regulatory affairs, business development and more. In fact, I have worked as a consultant at companies where there are barely any permanent staff members. Even the oversight of the contract manufacturing organization (CMO) was outsourced to a third party (me!).
Outsourcing is so common that regulatory bodies have written it into their regulations and guidances (1), and there are conferences and entire magazines dedicated to the topic. I too have spoken and written about outsourcing on numerous occasions. In general, most people focus on the themes of best practice and ensuring success (2-4), and almost all articles assume that if you plan well then everything will go well. But when does life ever go according to plan? As Robert Burns wrote in ‘To the Mouse’ – “The best laid schemes o’mice an’ men, gang aft a-gley”, which, when translated and simplified, means that even the best plans often go awry. In other words, you should always assume that something will go wrong – and have a Plan B.
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