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What is a qualified person in the pharmaceutical industry?
A qualified person, or QP, is the person who certifies that each batch of a medicine was made and tested according to its marketing authorisation and EU GMP before it can be sold in the EU. Every holder of an EU manufacturing authorisation must have at least one QP at its disposal. The role is set by Directive 2001/83/EC, and the QP is personally responsible for the certification. In pharma, qualified person means this legal role, not the safety roles that use the same name in other industries.
- 5 related courses
- 37 hours of audio across them
- certificate and training record
- delivered in 72 hours
What does a qualified person do?
The QP certifies each batch before release. To do that, the QP must be sure that every step, from starting materials to packaging, followed GMP and the marketing authorisation. In practice the QP reviews the batch record, the test results, deviations and changes, and the status of every supplier and contract site involved. The QP can refuse to certify, and the company cannot override that decision.
How does QP release work under Annex 16?
Annex 16 of the EU GMP guide describes batch certification in detail. It covers what the QP must check, how responsibility is shared when several sites and several QPs are involved, and what happens when an unexpected deviation is found. It also covers batches imported from outside the EU, where the QP relies on audits of the overseas site, testing on import and, where it exists, a mutual recognition agreement.
Who can become a qualified person?
The person must meet the education and experience rules of Directive 2001/83/EC and be accepted by the national authority, which names them on the company’s manufacturing authorisation. Many QPs come from quality assurance or quality control. Because the QP is personally responsible, the job demands both technical depth and the confidence to say no.
Why does the QP matter to the rest of the company?
Production, quality control, supply chain, regulatory and sales teams all feed the QP’s decision. Investigational medicines in clinical trials also need QP certification. Suppliers outside the EU deal with the QP through audits and quality agreements. The courses below explain the role and how to work with it, by role, with a recorded questionnaire at the end of each module.
This guide belongs to Training for Quality assurance and Qualified Person in pharma: 257 audio courses, 257 courses.
Courses that teach this, priced per learner per year
Each course is audio modules in three lengths, with workbook, transcript, a recorded questionnaire per module, a certificate and the training record. Prices are the list price per learner for a year; the price falls with more learners.
- The signature that stops a batch: what the Qualified Person actually does6 modules · 6 hours of audio · Management, QA, BD · 54 EUR per learner per year
- Talking to a QP, a Responsible Person and a pharmacovigilance lead: what each one owns5 modules · 5 hours of audio · Sales, BD, RA · 45 EUR per learner per year
- Quality assurance and Qualified Person: everything Europe expects of you, in one course10 modules · 10 hours of audio · Quality assurance and Qualified Person · 90 EUR per learner per year
- Quality assurance and Qualified Person: your first month in pharma, starting from zero8 modules · 8 hours of audio · Quality assurance and Qualified Person · 72 EUR per learner per year
- GMP for investigational products and clinical supply: Annex 13 in practice8 modules · 8 hours of audio · CRO, CDMO · 72 EUR per learner per year
Questions about qualified person
What is QP release?
QP release is the common name for batch certification. The QP checks that the batch was made and tested as registered and under GMP, then certifies it in a register. Only after that certification can the batch be released for sale or supply in the EU.
What qualifications does a QP need?
The directive requires a university degree in a relevant science, such as pharmacy, chemistry or biology, covering set subjects, and at least two years of practical experience in an authorised manufacturer. Each member state checks the qualification and keeps its own detailed rules.
Does a QP release imported batches?
Yes. A batch made outside the EU must be certified by a QP in the EU before it is sold. Unless a mutual recognition agreement applies, each imported batch is also tested in the EU. The QP relies on audits and quality agreements to trust the overseas site.
Why does a supplier need to understand the QP?
Because the QP decides whether your material ends up in an EU product. The QP needs your GMP evidence, your change notifications and honest answers on deviations. A supplier that makes the QP's job easy gets approved faster and keeps the business.
Is a QP the same as a responsible person?
No. The responsible person is named on a wholesale distribution authorisation and is accountable for good distribution practice. The QP certifies manufactured or imported batches. Both are legal roles, and some companies need both.
Is the course certificate a QP qualification?
No. Only a national authority can accept someone as a QP. The certificate records that a named person completed the course and its questionnaires, with hours, guideline version and date. It is evidence of training, not a professional qualification or an accreditation.
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