QP Service
Before medicinal product release into the European Union market or before it’s administration to the patient during clinical trials, each batch of a given medicinal product needs to be certified by Qualified Person (QP) followed by drug release to the market process commonly known as a QP release (batch release). In the case of the import of pharmaceutical product from a third country into the EU, batch certification and release by QP are strictly required. At SciencePharma we provide QP services. We invite you to learn more about Qualified Person scope of activities and advantages of EU batch release by SciencePharma.
Qualified Person – what is QP responsible for?
Regardless of the manufacturing site location, there is a need for strict control of their manufacturing and quality properties to ensure high standards of medicinal products. According to Article 48 of a Directive 2001/83/EC, Qualified Person is the one to take the main responsibility for the quality of respective medicinal products, certifying each batch of a medicinal product to meet the quality requirements. Before the introduction of each batch to the market or before its administration to patients during clinical trials, it must be verified by QP in terms of:
- medicinal products quality,
- manufacturing in compliance with Good Manufacturing Practice (GMP),
- compliance with documentation approved by the Competent Healthcare Authorities.
Pharmaceutical product distribution to customers in each county is performed in accordance with local relevant requirements. However, it is always obligatory for QP batch release on the EU territory to be performed prior to transportation to relevant EU countries as well as outside the EU.
The scope of QP service provided by SciencePharma
At SciencePharma we support our Clients with the QP services of EU Batch Certification and Batch Release for:
- final medicinal products (Drug Products, DP),
- and Investigational Medicinal Products (IMPs).
The QP services provided are dedicated to a variety of medicinal products involving:
- sterile medicinal products,
- non-sterile medicinal products,
- and biological medicinal products.
SciencePharma’s QP service may be provided regardless of the location of the medicinal product manufacturing site:
- for medicinal products manufactured in the EU,
- and for medicinal products manufactured outside the EU (imported from third countries).
Activities performed as part of the QP service
QP service provided by SciencePharma includes the following activities:
- QP Batch Certification,
- QP Batch Release,
- Audits and reviews of all batch records and test results,
- Provision of Certificates of Release to allow drugs to be distributed within the EU and outside the EU,
- Management of recalls, complaints, suspensions and batch withdrawals, if required,
- Supervision of serialization alerts,
- Contact with Competent Healthcare Authorities with regards to quality testing, quality defects if applicable, Inspections, etc.,
- Overseeing a fiscal flow-chain,
- Management of a physical flow-chain,
- Optimization/ overseeing of logistics,
- Assurance of adequate Quality Control of products,
- Assistance with Batch Expiry Extensions.
In addition to standard activities, batch certification and batch release may be extended with side services as listed below:
- Audits of medicinal product manufacturing sites,
- Audits of Active Products Ingredient (API) manufacturing sites,
- Support for manufacturers in preparation for EU GMP certification,
- Scientific and substantive support of manufacturers and Marketing Authorisation Holder in case of any difficulties concerning a product’s quality or manufacturing process,
- Consultancy services Relating to Regulatory Affairs,
- Cooperation with a network of reliable subcontractors for analytical and microbial sample testing.
What about QP service for Investigational Medicinal Products (IMPs)?
In terms of Investigational Medicinal Products QP is responsible for certifying that each batch of IMP has been manufactured and tested / checked in accordance with:
- EU GMP,
- The IMPD (Investigational Medicinal Product Dossier) or the CTA (Clinical Trial Authorisation),
- The Product Specification File (according to Annex 13 to the EU-GMP Guide).
Requirements to be a QP
The requirements for performing the QP function are precisely regulated and only people who meet certain criteria can perform these services. Appropriate education is required for a qualified person (QP needs to have a diploma in pharmacy, medicine, chemistry, pharmaceutical chemistry and technology, biology or veterinary medicine). In addition, the course of a QP’s education has to include strictly defined subjects as specified in Article 49 of a Directive 2001/83/EC.
Moreover, QP needs to be able to prove prior experience of working for at least two years in a company or facility being authorized to manufacture medicinal products, performing duties in areas of qualitative analysis of medicinal products and quantitative analysis of active substances. In addition to that, experience in quality management processes including participation in audits and inspections is one of the essential requirements as well. Experience in the registration of medicinal products, although not required by law, is a great advantage.
To sum up, Qualified Person is obliged by law to:
- be well educated in strictly defined specializations,
- possess certain, high level of skills and knowledge,
- be experienced in relevant practice.
Our team of experts here at SciencePharma meets all the necessary criteria. With many years of valuable experience, we are ready to undertake QP responsibility over Clients’ medicinal products.
Experience of our QP experts
Our team of highly qualified experts and QPs with years of experience and everyday practice will verify batch data and confirm if the product quality meets desired standards. On top of that, compliance with EU GMP standards and MA requirements will also be validated.
During the batch certification process, QP examines numerous quality documents such as batch records, analytical results, transport records, deviations, out-of-specification results, complaints, “ongoing” stability study results, and many more. Based on the outcome of such a wide analysis, QP decides whether a given batch of a product may be released into the market. SciencePharma’s experts have a world-wide extensive experience in batch release and certification of medicinal products and IMPs derived from both the EU local market, and form European countries that are not part of the EU (i.e. UK, Balkan countries), and others such as Canada, India and Saudi Arabia). Our activities include GMP audits at sites involved in the manufacturing and distribution of medicinal products, and being involved in complaint handling and recall processes.
At SciencePharma we provide more than consulting…
and our QP service is more than batch release
Apart from QP service, we deal with all the aspects related to organization of analytical batch release studies in the European Union in contract laboratories with whom we have been cooperating for years. Thanks to this, we can take care not only of QP release, but alsoorganize and supervise other manufacturing sites required in the process, including quality control sites. Efficient cooperation with contractors and control of product life-cycle before release on the market ensures efficient marketing of the product and minimizes the risk related to withdrawals or complaints.
It is not without reason that we repeat about the extensive experience in providing QP service, as we truly have brilliant specialists behind whom there is a group of satisfied Clients from all over the world. Above all, we have practical skills confirmed by many years of practice in conducting audits and support in the field of regulatory issues. This distinguishes us from the competition and allows for comprehensive consultancy for the development of our clients’ pharmaceutical businesses.
For more details on the possibility of cooperation, please contact us directly.