MEETING POINT: THE EUROPEAN QUALIFIED PERSON FORUM
The European QP Association was established only a little more than three years ago, yet this organisation uniting Qualified Persons from across Europe counts more than 1.000 members, increasing the association's importance within European organisations. For instance, Advisory Board members have been invited to EMEA Interest Party Meetings several times. This helps to approach the goal to address the special challenges and problems QPs encounter every day and to advance harmonisation regarding European regulations. The QP Association has also established a platform for exchanging information, enabling members to discuss latest developments and issues as well as questions and to identify common challenges.
A very important international conference in the area is the QP Forum conducted annually by the QP Association. This Forum allows attending QPs to network and exchange experiences well as to get the latest news - and to find appropriate solutions for today's issues. Along with representatives from various European associations and authorities more than 240 European QPs got together at last year's QP Forum in Munich, Germany.
For the 2009 QP Forum the Advisory Board has once again prepared a very interesting programme. Almost 20 speakers - among them seven authority speakers - will discuss various subjects the board identified as "burning issues" following last year's programme and the Q&A session (please also see the following Q&A excerpt on the next page) and which are therefore specifically interesting for European QPs. For instance, a lot of QP Association members work in the area of approving clinical trial medicines. For that reason the IMP Working Group will again conduct a pre-conference workshop and a special session during the Forum concentrating on issues related to this topic.
Furthermore, contract QPs get more and more in the centre of attention. These QPs commonly work for various contracting parties and release products as external service providers rather than as in-house QPs. The details to be considered in this regard will be discussed in a special session moderated by a Qualified Person and an authority representative.
A lot of inquiries are also related to the subjects liability and QP insurance options. These issues will be covered by an attorney who is a specialist in liability and insurance questions. Other sessions will discuss subjects including
- The role of the QP in biotech
- Counterfeit Drugs
- Deviations, OOS and trends
- Risk management
- Work organisation
- Supplier qualification
Q&As Session during the 2008 QP Forum
During the last QP Forum, delegates were able to address questions to the speakers and the Advisory Board. In addition to answering them in a dedicated session, the Q&As were summarised and published in three sets on the website. For the complete Q&A list please see "QP Publications" in the "News/Publications" section at www.qp-association.eu.
Requirements for releasing Biologic/Biotech Products
Q: What are the knowledge, academic, and experience expectations for a QP that is responsible for releasing Biologic/ Biotech products as compared to small molecules?
A: The academic qualifications of the QP do not change. In some countries they can only be a pharmacist; in other countries they can hold either a Pharmacy, Biology or Chemistry degree. They then have to satisfy the regulatory authorities that they understand the legal requirements of a QP and have sufficient practical experience within the pharmaceutical industry and must have worked for at least 2 years within the industry including experience in the Production, Quality and Laboratory areas and be able to demonstrate they are knowledgeable and are also competent in such things as GMP, statistical analysis and risk based assessments, have good communication and interpersonal skills and clearly understand the dosage form they are certifying with respect to the process and the possible patient and business risk associated with the release, or non-release, of a batch of product.
Contract Manufacture and Analysis
Q: In case of an existing quality agreement, is it sufficient to rely on the certification of other QPs or should there be a review of for example batch records and deviations for the final release?
A: In theory it is sufficient to rely on the certification of other QPs if the final certifying QP has knowledge of the other QPs and of the quality systems within which each of them is operating. In practice I would recommend that the final QP should be aware of any matter that might affect his/her decision to release (for example deviations or OOS results/investigations) and to review documentation from time-to-time, particularly if contract manufacturers and contract QPs are involved in the process.
Manufacture of Investigational Medicinal Products (IMPs)
Q: Does the Reflection Paper on QP Discretion apply to release of IMPs? (with respect to deviations to what has been defined in the IMPD).
A: It does. It is the responsibility of the QP to ensure IMP (Investigational Medicinal Product) batches used in Clinical studies comply with cGMPs, with the CTA and with the Product Specification file, and to ensure patient safety.
In the introduction part of the reflection paper the Clinical Trial Direction CTD 2001/20/EC is referred to, a directive mandatory for all QPs working in an R&D environment.
Also the production of IMPs involves added complexity, in comparison to production of marketed products, by lacking fixed processes. As such good communication between the R&D product development departments and regulatory affairs however is key, to ensure that the filed specification are broad enough to avoid regulatory impact if changes occur.
In case there are deviations from the filed CTA, amendments can be submitted to the involved (EU) HAs. In that situation the QP needs to wait for certifying and releasing the final IMP till approval is granted by the HAs.
Q: Annex 13 requires that the QP must have experience with clinical trials. What do inspectors / regulators expect with respect to QP experience with GCP?
A: They might expect knowledge of GCP basics, and besides the usual GMP, galenic experiences and experiences in handling new materials and knowledge of the various processes from phase 1 to phase 3.
External (Contract) QPs
Q: Outsourcing the QP batch release:
- What are the pre-requisites (GMP and legal)?
- What experience is needed?
- Are there any existing models as a reference?
A: The QP must be named in the manufacturing authorisation (in Germany). The QP must be endorsed by the competent local authority according to the national law. There must be a written agreement between the QP and the manufacturer, clearly describing the role and responsibility. The permanent availability of the QP must be assured, the frequency of on-site availability and the way the QP gets all relevant information must be defined.
The QP must be appropriately experienced in the manufacture and quality control of the product type manufactured by the contract giver. In case the products need additional formal education or experience like blood products, the QP must comply with these requirements.
Q: Contract QPs: Is there any guidance available defining "sufficient" time on a site to familiarise the QP with the Quality System?
A: There is no guidance available. My thoughts are that the time on site will depend on the complexity of the quality system. An important consideration is the maturity and stability of the system. If the system is mature and stable a shorter time on site may be indicated, provided that the contract specifies that the QP must be made aware of any changes that affect the quality system.
Liability
Q: How many QPs have actually been sent to jail in case of violations?
A: We are currently not aware of anybody in EC sent to jail. The penalties for nonconforming behaviour of QPs are mostly leading to fines and not to terms of imprisonment. The last may be relevant in cases of intentional release of unsafe products or danger for patients. However liability and possibilities for insurance is a task QPs should be well informed.
Author:
Wolfgang Schmitt
CONCEPT HEIDELBERG
