The research-patient-research loop
Is supply chain validation worthwhile in the pharmaceutical and healthcare industry?

Manufacturers of drugs and medical devices validate their production processes, as required by law. But the supply chain is a different story, and enterprises and regulators are only now beginning to make this the focus of systematic quality assurance. Now some companies are adopting supply chain validation for good business reasons, irrespective of any legal pressure.

In pharmaceuticals, medical devices and biotechnology, the traditional workflow starts with the raw material and ends with the patient. But it is possible to work the other way, too. Manufacturers increasingly rely on feedback from patients to optimize their research and production processes. One example is tailored drugs based on patients’ genetic data. This is one reason why healthcare companies are beginning to concentrate on communication along the supply chain. They have to ensure that the right drugs get to the right patient, and that data gathered in distribution or clinical practice can flow back to them. This is particularly important when drugs may have to be recalled. As a result, companies are moving towards Good Distribution Practice (GDP) and Good Clinical Practice (GCP) as well as the traditional Good Manufacturing Practice (GMP). Regulatory authorities are becoming increasingly active in this area. In Europe, for example, the first EU Directives on this subject, 92/25/EEC, 2001/83/EC and 2004/27/EC, have already been adopted, and more extensive national regulations are currently being drafted.

Supply chain validation poses a great challenge for enterprises. Whilst validating individual systems is not particularly complicated, a supply chain is a complex structure of different systems and processes. It also involves a range of organizations: research laboratory, manufacturer, suppliers, logistics partners, and the clinical environment.
Every interface is a potential source of error. In addition, distribution channels are becoming more and more diverse, new regulations are coming into force, and new technologies such as RFID (radio frequency identification) are being implemented. In the medium term, RFID will supplement rather than replace current labeling methods such as barcodes. The technology can detect counterfeit drugs and trace packages back to their source, but the regulators still believe that the radio chips used for RFID might interfere with other clinical equipment. As a result, the industry will still have to deal with a variety of labeling methods when validating supply chains.
With all this in mind, do validation projects in distribution and clinical practice pay off? They certainly help companies prevent harm to the patient through poor traceability or slow recalls. This avoids additional regulations, which are almost always issued as a result of such problems and are always more expensive than voluntary initiatives. So supply chain validation makes sense for business reasons as well as patient safety. It also creates the basis for a compliant supply chain, which gives enterprises access to valuable data gathered in clinical practice. A prerequisite for this approach is to abandon the short-term perspective of many IT projects. Rudolf van Megen, CEO of validation specialist SQS Software Quality Systems, says: “A lot of people only look at the costs of validation. The costs saved during operation thanks to quality assurance are rarely calculated. Our experience shows that validation actually pays off in the short to medium term if it is accompanied by professional risk management.”
A further crucial aspect is patients’ reactions to the data flows within a compliant supply chain. Only if those data flows are quality-assured, including data protection, will the industry be able to build the necessary trust.