Qualified Person in a nutshell: requirements, activities and responsibility of a QP
Batch certification, GMP audtis, flow chain - what does Qualified Person really do?
- Read our article about QP service.
Requirements concerning manufacturing and quality of medicinal products are very strict and complex. Before each batch of a given medicinal product is introduced into the market or before it is administered to a patient during clinical trials, it must be:
- thoroughly verified in terms of its quality,
- manufactured in compliance with Good Manufacturing Practice (GMP),
- in agreement with documentation approved by the Competent Healthcare Authorities.
To ensure the above mentioned, the European Union appoints a so called Qualified Person (QP) who takes major responsibility for quality of respective medicinal products (Article 48 of a Directive 2001/83/EC) .
Not everyone could be a QP. A QP by Law, must be appropriately educated, have relevant knowledge and confirmed experience, and perform series of tasks and activities that assure high quality of a medicinal product. All of it is described below, as based on respective EU law (Article 49 of a Directive 2001/83/EC) .
A QP has to understand the scientific quality principles behind the medicinal product that she or he releases to the market. To prove it, a QP needs to have a diploma in one of the following scientific disciplines:
- Pharmaceutical chemistry and technology;
- Veterinary medicine (concerning a QP certifying veterinary medicinal products).
In addition, the course of a QP’s education has to include at least the following subjects:
- Applied physics;
- General and inorganic chemistry;
- Organic chemistry;
- Analytical chemistry;
- Pharmaceutical chemistry including analysis of medicinal products;
- General and applied biochemistry (medical);
- Pharmaceutical technology;
- Pharmacognosy (study of the composition and effects of the natural active substances of plant and animal origin).
All of the above listed subjects are obligatory according to regulations which in practice means that to be a QP you need to be a pharmacist, or if you have other education you must participate in postgraduate studies in order to gain knowledge in all the required fields.
The QP shall have acquired practical experience over at least two years, in one or more companies or facilities which are authorized to manufacture medicinal products. The activities should be performed in areas of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the whole quality management process including participation in audits and inspections. Experience in registration of medicinal products, although not required by law, is a great advantage.
To sum up, a QP must be highly educated, possess certain high level of skills and knowledge as well as relevant practice.
A QP needs Article 51 of a Directive 2001/83/EC  to make sure, that only the product that meets its quality gets to the patient. In practical terms, QP conducts and oversees various activities affecting product’s quality and releases a product into the market, which include:
- Batch certification both for drug product release into market (DP batch release) and investigational medicinal product release for clinical trials (IMP batch release);
- GMP audits of drug product manufacturing facilities, quality control laboratories (QC laboratories), warehouses and transportation companies;
- Management of recalls, complaints, suspensions and batch withdrawals; if required;
- Contact with Competent Healthcare Authorities with regards to quality testing, quality defects if applicable, Inspections etc.;
- Overseeing of a fiscal flow-chain;
- Management of a physical flow-chain;
- Optimization/ overseeing of logistics;
- Assurance of adequate Quality Control of products;
- Audits of Active Pharmaceutical Ingredients’ (API) manufacturing sites and issuance of a QP declaration (The QP declaration is the document ensuring that an active substance manufacturing site performs tasks in line with the EU GMP standards);
- Scientific and substantive support of manufacturers and Marketing Authorisation Holder (MAH) in case of any difficulties concerning a product’s quality or manufacturing process.
A QP, as a person responsible for a product quality, in his or her day-to-day work, has to gather and analyze tons of data and documents. In order to release one batch of a respective medicinal product a QP has to examine usually hundreds of pages of various documents such as batch records, transport records, deviations, out of specification results, complaints, product quality review, “ongoing” stability study results and many, many more. Based on the outcome of such a wide analysis, a QP decides whether given batch of a product may be released into the market.
This great responsibility for patient’s safety while using medicinal products is multiplied by legal responsibility imposed on a QP by law (Article 52 of a Directive 2001/83/EC) . In cases of negligence, recklessness, corruption, other offenses concerning release of substandard batches or failures to fulfill obligations, as per regulations, QP may be punished by fine, suspension, removal from the QP’s position or even imprisonment. Sounds scary? In a way, probably yes, since the responsibility that lies on QP is really huge. Nevertheless, the position of QP is extremely interesting and important in the company, you can even say that it is a key position, so it is definitely worth developing in this direction.
It is worth mentioning that QP is not the only one who can be punished. Namely, in case that manufacturer persuades and incites QP to release batches of inadequate quality the manufacturing site can lose manufacturing authorisation (Article 43 of Pharmaceutical Law) . For this reason, a QP must always act independent and cannot be influenced by any means.
The work of qualified persons is worth appreciating – thanks to them, we as patients, can take medicines safely and if it hadn’t been for a qualified person, we wouldn’t even have the medicines introduced into a market.
To sum up, in order to ensure quality of medicinal products, EU Law establishes a QP position upon whom great responsibility is imposed. Therefore not everyone can act as a QP. Only the most educated and qualified people can take this role and be responsible for quality of medicinal products released into the market and for patients’ safety. Assertiveness is also definitely a desirable feature for the QP figure because, like the above-mentioned - QP decisions must be independent.
At Health-Med we provide you with a wide scope of QP services to ensure that your medicines meet all the complex and stringent EU requirements, since we have a team of highly educated Experts, Auditors and QPs with very broad knowledge coming from wide range of scientific backgrounds but also hands-on experience. Supplemented with comprehensive regulatory and GMP knowledge, we are confident and proud to say that Health-Med’s QP services are of the highest quality, which you may find of use in your specific project.
Health-Med’s QP services due to comprehensive regulatory and GMP knowledge as well as experience of our team are of the highest quality and will help you meet the complex GMP and regulatory requirements.
You may also be interested in other services provided by Health-Med associated with QP:
- Import and supply chain management? Distribution of products for clinical trials?
- Audits for compliance with GxP (GMP audits, GCP audits)? GMP system implementation? Preparation for the inspection?
Please, contact us for detailed information.
 Article 48 of a Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
 Article 49 of a Directive 2001/83/EC
 Article 51 of a Directive 2001/83/EC
 Article 52 of a Directive 2001/83/EC
 Article 43 of Pharmaceutical Law