​Product complaints are a fact of life.  However, the pharmaceutical industry is unique; with its levels of regulation, complex nature of complaints, heightened customer expectations, and the product and process improvement opportunities that complaints offer.  Whilst a number of industries have more complex regulations, none have the range of possible complainants; whether sophisticated and knowledgeable prescribers, or patients with, in some cases, little understanding between an Adverse Event and a product complaint.

Given the need to meet diverse regulations and a variety of complainants, the industry has simply settled for handling complaints as expeditiously as possible, without really looking for long-term product improvements, customer service opportunities, or on-going improvements to the complaints' handling process.  Even the CAPA processes often drive a 'lip-service' attitude which fails to look deeply enough into complaints.

Typically, this has meant companies implementing a process that ticks the relevant local regulatory boxes and makes a basic attempt to correct on-going issues; rarely revisiting the process to ensure it is effective and operating at optimum cost.  The best case scenario is that the same complaint is prevented from reoccurring, but underlying product issues are rarely addressed.  The best method for future communication is not identified, and the prevention of similar issues in future products is not ensured.

So, how can companies make use of the complaint information and customer contact opportunities that a complaint provides?

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turning regulatory requirements into business benefit.pdf