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Decreasing the risk in pharmaceutical specials manufacturing

Pharmaceutical specials, known “specials” in Europe or compounded drugs in the US, play an essential role in modern healthcare. Without specials, patients for whom licensed pharmaceuticals are not suitable would not be able to receive proper treatment. Manufacturers of specials perform the seemingly impossible each day by quickly producing custom medicine for sick patients, while maintaining the highest quality standards.

Rapid turnaround, small batches and custom formulations all increase the risk of something going wrong during the manufacturing process which can have severe consequences in the clinic. In order to reduce these risks, specials manufacturers are moving from a reactive model of quality assurance, to a proactive approach.

Personalised medicine
There are a growing group of patients who rely on specials for their treatment. Typical groups include:

  • Babies and infants requiring lower doses
  • Patients with allergies to licensed medications
  • Patients where dosing is critical and all medication must come from the same batch
  • Patients requiring medication that is out of stock
  • Patients who require medication shipped from abroad where quality cannot be monitored
  • Patients who require doses that are difficult to measure using standard licensed medication

Source: APSM

As diagnosis methods become more advanced and personalised medicine becomes a reality, more and more patients will likely require custom formulations for their medication and the specials manufacture industry will become more important than ever.

Specials industry is based on trust
Although considered to be more risky than licensed medication, clinicians and pharmacists can use them because they can trust that when they receive a medication from a specials manufacturer, the label and the contents are going to be perfectly matched. This trust has been built up over time with the help of regulations and certification processes that help to guarantee the quality of specials products.

This guarantee is essential as physicians who prescribe specials are on the front line of clinical care and do not want to take risks with the health and ultimately the lives of their patients. When prescribing bespoke medication such as a special there is an element of risk involved, so specials manufacturer need to do everything that they can to reduce this risk.

There is a trend in quality assurance moving from a reactive to a proactive model. Traditional reactive approaches identified problems and introduced processes and regulations to fix them. The problem with this approach in an industry like specials manufacturing is that when a problem arises, it starts to erode bedrock of the industry: trust. The more problems that are exposed, the more trust is eroded, which is why proactive quality assurance is becoming essential to maintaining the specials industry.

The benefits of proactive quality assurance
While regulators around the world are starting to demand proactive quality assurance in many different industries, there are many benefits to those companies who implement it quickly, including:

  • Getting in front of the regulations
    Often, regulations put manufacturers on the back foot leaving them scrambling to adapt workflows and processes in order to comply. With a proactive approach, manufacturers can work on quality assurance solutions in ways that suit their own business and protect their customers.
  • Helping shape the regulations
    While there are less regulations for specials than for licensed medication, the number of regulations are increasing all the time. Manufacturer’s engaged in proactive quality assurance can quickly become seen as industry leaders and beacons of quality by regulators and customers alike. Innovation by manufacturers can help guide regulator and monitoring frameworks in the future.
  • Improving quality and safety
    By being proactive and anticipating potential sources of problems in the specials manufacturing workflow, the quality and safety of both the manufacturing process and the finished product is going to improve. In many cases, an investment in proactive quality assurance is investment in higher quality products and improved customer satisfaction.

How to implement proactive quality assurance
Proactive quality assurance means regularly reviewing all parts of the manufacturing process from training to the testing of the end product. Staff training should include components on proactive quality assurance and provide clear channels for anyone working on production to suggest improvements. Work culture should also revolve around maintaining the highest levels of quality.

When it comes to the specials themselves, it is critical to test every batch. This goes from the raw materials to the end product. It is also extremely valuable to have a testing system that can take regular samples throughout the manufacturing process to ensure that everything is going as expected. Testing throughout production can mean that batches can be saved, or at least discarded before any more time or raw materials are wasted.

When thinking about testing the end product it’s important to also consider the certification. What data can be shown to clients and regulators to give them the confidence needed in order to trust the products? The industry standard for this is HPLC which gives an extremely accurate readout of purity and concentration. The drawback of HPLC is that it is costly and time-consuming meaning that quality testing can be performed less frequently than is optimal. However, there are many different analysis methods that can be carefully calibrated and benchmarked against HPLC that could provide a faster and cheaper quality data certificate. One such method is absorption spectroscopy which uses UV light to quickly measure liquid formulations. When carefully calibrated to HPLC data from a variety of different batches, absorption spectroscopy can be a powerful method to increase the stringency of product testing without the long waiting times or high cost.

To find out more how absorption spectroscopy was used in the quality control of cytostatic drugs, download our white paper.

Download White Paper – Quality control of Cytostatic Drugs

Proactive quality assurance puts control into the hands of the manufacturer. It gives producers of pharmaceutical specials the opportunity to say how their production will be controlled and monitored to deliver the highest quality results. Ultimately, quality control benefits everybody in the manufacturing process as well as the clinicians and the patients. The key is to find quality processes and monitoring methods that integrate as seamlessly as possible into manufacturing workflows.

Read more about DrugLog® – Pharmaceutical quality assurance in seconds.

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