Qualified Person
QualifiedPerson.com is a dedicated resource and information portal for the QP industry.
What is a Qualified Person?
A qualified person has an immensely important role within the pharmaceutical profession. The word ‘qualified’ has more than one meaning here. Firstly the person concerned should indeed be suitably qualified in depth for their role. But the second meaning concerns the job as well. The person in question must be qualified to be able to certify that the drug or drugs that have reached them are in a condition fit to be used by those they are intended to reach next.
The basic role of a qualified person
The role of a qualified person (often shortened to QP for ease of use) generally falls into one of two areas:
- The certification of products to be used in clinical trials
- The certification of products to be used by the general public
All of these products will be medicinal in nature. As such the QP is required to have had extensive training in the field prior to taking the position. The addition of medicines to be certified for use in clinical trials only occurred a few years ago. Prior to this, the chief role of a QP was to certify those drugs that were about to reach the wider marketplace for use by the general public.
Do they certify drugs only for humans?
A qualified person will also certify drugs that are intended to be used for veterinary purposes. In both situations, whether required for humans or animals, such drugs may be available over the counter or on prescription depending on their use and intention. In either case the role and responsibility taken on by the QP cannot be underestimated.
How does one become a qualified person?
There are strict rules and regulations surrounding the journey to fulfil the role. Traditionally speaking, most people who are elevated to the role come from the ranks of pharmacists or chemists, or some other similar area. The person should have recognised qualifications in the area that show their extensive knowledge.
But even this is not enough for one to be considered for this very important role. Several years’ worth of experience in a relevant field in this sense will also be required. It can take many years for a particular drug to be developed in the first place. It is absolutely essential that nothing reaches the marketplace that should not be there. The qualified person must be able to follow the rules and ensure that only the correct medicinal products are approved to reach the marketplace.
The important role of a QP
It cannot be underestimated how important the role of a qualified person is. The person performing this role is the final step before a specific drug will make it through to be used for a clinical trial. It will also be the final step before a certain drug will be sent to pharmacists to sell to the general public, regardless of whether a prescription is required or not.