We display huge amounts of trust when we pop paracetamol into our mouths to ease headaches. We trust that the labelling is correct and that the ingredients listed on the side of the package match the contents. We are confident that the recommended dose is correct and will not cause any unforeseen side effects and, above all, we believe that the product is safe and will be beneficial rather than detrimental to our health. In reality, we often don’t think about any of this when we take a painkiller or prescription drug, but our lack of worry rests in part on the diligent efforts of pharmaceutical services providers (PSPs) that play an important role in ensuring that no drug reaches the market without rigorous testing and regulation.
So, what exactly is a PSP? A PSP is an external organisation that works with a pharma company throughout the development of a new medicine. Outsourcing activities to a PSP is financially favourable – by reducing overheads and minimising investment in facilities – while also allowing the client to draw on specialised expertise, benefit from an improved time-to-market, and ensure that personnel are investing in areas where they will be most effective. Take Hexagon Tower occupier Intertek for instance, a leading Total Quality Assurance provider to industries worldwide that specialises in supporting complex pharmaceutical product development through industry-leading analytical and regulatory expertise.
Drug development is a long, drawn-out process that can be divided into three main stages: preformulation, formulation and product release. In preformulation, scientists identify an active pharmaceutical ingredient (API) and characterise its physicochemical properties, such as efficacy and safety. The next formulation stage involves combining the API with other chemicals to develop the medicinal ‘package’ and determine an appropriate delivery method and dosage before clinical trials can begin. Everything must be performed to the highest standards in accordance with Good Laboratory Practice, Good Clinical Practice and Good Manufacturing Practice, and this is where many PSPs fit in, offering regulatory-driven laboratories that carry out method validation, stability studies, analysis and much more throughout the drug development process.
However, developing a drug is only part of the story; it’s not enough to simply have a good product. The global market is overseen by governmental regulatory agencies and, in the UK, a company must have an approved clinical trial application from the Medicines and Healthcare products Regulatory Agency (MHRA) before any testing in humans can occur. During the trials, the MHRA will continue to inspect the process and assess compliance with current guidance and legislation, and a drug can only be made commercially available after a product licence has been granted. Legislative compliance is both important and complicated and, again, PSPs can help with regulatory guidance that supports pharmaceutical companies through the process.
Supply chain auditing
In many industries, the economic benefits of a global supply chain can become increasingly complex when it comes to safety, risk and regulatory compliance; there are significant risks when the manufactured product has the potential to cause great harm if the supply chain is compromised. For example, in 2008, sales of the blood thinner heparin were suddenly halted when several patients died and many suffered adverse effects as a result of a contaminant in the drug, which was traced back to a chemical plant in Changzhou, China. The costs – both in terms of human safety and money – are huge if something goes wrong once a drug has come to market, and PSPs can play an important role here too, maintaining thorough supply chain audits to ensure high quality materials are used, and that all manufacturing complies with legislation.
A lot goes on behind the scenes
So, the next time you swallow a paracetamol or take a prescription drug, take a moment to consider the people hours, research, applications, clinical trials, auditing, paperwork and regulatory oversight that is required before a drug even reaches the pharmacy shelves. In a world of well-known pharmaceutical companies, spare a thought for silent partners like Intertek behind it all; the pharmaceutical industry relies on these kinds of PSPs to ensure that drug development and the product pipeline are secure and compliant so that we, the consumers, can be confident that what’s inside the medicine packet will do us good.