Why is a Qualified Person important for a pharmaceutical company?

The ‘Qualified Person’ (QP) has been introduced within the pharmaceutical industry to safeguard the company against scandals. The QP needs to keep a close eye on everyone involved in the manufacturing and distribution process to ensure patient safety. Even though delegated, this makes the QP ultimate responsible for the quality of each single batch of medicine.

The title of QP has to be earned. It requires official certification issued by governments.

So the QP has as main concerns:

  • Ensuring patient safety, followed by
  • Complying with compliance, and finally
  • Persuading the company to keep their policy in line with patient safety and compliance.

 

With regard to company policy, this could be a difficult area for the QP to manoeuvre. While being employed by the company, the QP needs to remain independent. Even though this independence is a legal requirement, any identified non-compliance could put a strain on company loyalty.

A successful QP finds a balance between:

  • Skills, experiences, moral values and motivation; as well as
  • Tasks, responsibilities and authorities; and
  • Regulations, culture and customer/supplier relationships.

 

The QP requires a combination of very special set of characteristics:

  • Find flaws in the manufacturing and distribution processes, just like a private investigator
  • Prevent and repair malfunctions, just like car mechanic
  • Persuade people to apply common sense, just like a motivational speaker
  • Self disciplined, just like a marathon runner

 

The QP needs to understand and validate the following main process flows:

  • Procurement of raw materials
  • Manufacturing of medicine
  • Distribution of medicine

 

Apart from focusing on the flow of goods, the information shared is also important to verify and control. For example, the QP checks whether the following is up to date, complete and accurate:

  • Documented processes and procedures; Are we operating according to our own defined ways of working?
  • Printed labels on medicine: Is the information that we provide the patient before taking the medicine relevant, complete and accurate?
  • Printed information on delivery notes: Does the data on the required paperwork match what is physically being delivered?

 

As company directors, also the QP could be charged with corporate manslaughter when a scandal with deadly consequences has been identified. Therefore the QP requires an appropriate level of responsibility within the company.

The QP understands that it is vital to apply a pro-active approach to interpret compliance in order to prevent new scandals. This triggers continuous improvement to ensure that the company makes it their policy to put patient safety first.

When it comes to compliance, sticking within predefined budgets will become less important compared to potential loss of market credibility, turnover, cash flow and profit. Instead the QP will focus on reducing risk by implementing solutions with the most benefits and fastest Return on Investment (ROI).

A study showed that most QP’s are motivated by the responsibility the role provides. The least rewarding aspect is the lack of recognition and understanding of their role within the company, which is triggered by complacency towards compliance.

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