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European Qualified Person Association - Publications/Question and Answer Documents

Q and A Document No 2: Frequently Asked Questions

Question 1: For companies outside EU and MRA, but with many suppliers of marketed pharmaceuticals and clinical trial drugs within the EU, China, and India: what are the requirements for obtaining a Qualified Person Certification and serving the clients as a designated Qualified Person.

Answer:
Things that need to be considered are:
  1. The QP is linked to a European manufacturing authorization.

  2. If the "QP" is an employee of a company outside the EU, he/she is not employed by a company with European manufacturing authorization and therefore can't act as a QP.

  3. There is no such thing as a certification to be a QP. A QP is registered by the authority of the respective EU member state.

But international companies may name a QP outside the EU. The QP named does not have to be an employee of the company, but he/she could be contracted to the company for the purpose of acting as a QP. However in the case of a contract QP it could be argued that such a person may not satisfy the requirement to be "readily available" and to have an appropriate knowledge of the company's products and the manufacturing processes involved.

It is normal practice for the EU-based importer of a product manufactured in a third country to have available the services of a QP, so that the QP would be assessing a product/batch on first importation into the EU, on behalf of the EU. If an EU-registered QP is a permanent employee of a third country marketing/manufacturing authorisation holder, it could be argued that there may be a conflict of interest between this person's QP role and his/her relationship with his/her employer, particularly if that person was based at that company.

Question 2: Does a QP from an EU Member State who is appointed by the Member State's Main Pharmaceutical Inspectorate as a QP and is chemist and not a pharmacist can move to Germany and still carry out duties of a QP?

Answer:
Although the educational background would not be considered sufficient by the various local authorities in Germany to be initially accepted as a QP, a Chemist would be accepted once he/she is registered as a QP in another Member State. So once a QP is eligible and registered by another Member State authority he/she could apply as a QP in Germany. However it needs to be decided by the local German authority (e.g. Regierungspräsidium).

Question 3: If a company is based in Switzerland and produces APIs for the pharmaceutical companies, what are the possibilities for becoming a QP?

Answer:
As Switzerland is not an EU Member State, the applicable Directives apply via the MRA.
The QP in Switzerland is called the "Fachtechnisch verantwortliche Person".
To become a Fachtechnisch verantwortliche Person, an academic qualification is needed (for finished products and intermediates usually a pharmacists). Other academic qualification is acceptable in case of proven experience and for APIs and blood products.

The Notification is handled by Swiss Medic, and the "Fachtechnisch verantwortliche Person" will be named on the manufacturing license. We would recommend contacting Swiss Medic for further information.

Question 4: There are 3 professional bodies in UK who can grant QP status and can advise people that they are eligible for QP status as per EU Directives. However, it appears that some Member States do not recognise the definition of QP as per EU Directives. In France for example the 'Pharmacien Responsable' has to be a pharmacist qualified and registered in France. Is it possible to operate as a QP recognised by markets where our products are commercialised (all EU), while not being considered a QP by the country of manufacture?

Answer:
Directives are only binding as to the result to be achieved but shall leave national authorities the choice of form and method. The EU requirements as defined in the Directives have to be transferred to national law in each EU Member State. However, there are a number of differences in the EU Member States due to the fact that each Member State can implement the directives into national law with slight modifications. This national law is the binding one.
To operate as a QP one has to be named by the holder of marketing authorization in the EU and must be registered/ accepted by the EU member state where the company resides.

Question 5:  Manufacturing of tablets for a phase I and for a phase II study: is it possible to release and/or submit an IMPD or similar documentation without microbiological quality as a lot release parameters for tablets in phase I or IIa? (tablets do not contain any components that would by their origin have a high total viable aerobic count).

Answer:
Especially for IMPs manufactured the first times it should be proven that the microbial quality is satisfactory, since usually only limited experience and only little validation data are available.
Although the compounds are unlikely to be "contaminated", contamination may happen during manufacturing. Often the raw materials used for the manufacture are not tested for their MB status.

One approach could be to test at least the first 3 lots of a manufacturing sequence for MB status.

Independent of what is mentioned in the IMPD (and accepted by authorities), the QP keeps the final responsibility for the batch, and should be able to justify her/his release decision.
If the QP decides to release without MB testing, we would strongly recommend performing a risk analysis of the release decision.

Question 6: A company has been recently inspected by the respective national Inspectorate, and some of the observations of this inspection were made regarding the role of the QP with respect to the quality system. For example, they have asked to describe QP's responsibility with respect to approval of controlled documents (documents in the quality system). Is this required in the QP relevant legislation?

Answer:
It is a common misconception in these days that the QP is considered responsible for all aspects of a Quality Management System, especially for approval of all kinds of documents, forms and reports.

Although the QP's tasks and responsibilities are manifold it must be clearly stated, that a QP is not automatically the Head of a Quality Management System, Head of Quality Assurance, or Head of a Quality Control Unit. This may be the case in smaller companies. Very often it is not the case, the QP being a staff position outside the operative quality functions. The QP then has to rely - as mentioned in the Annex 16, 4.3 - not only on other QPs but also on other staff and the Quality System:

"The Q.P. who certifies a finished product batch before release may do so based on his personal knowledge of all the facilities and procedures employed, the expertise of the persons concerned and of the quality system within which they operate…" These are especially the Head of Production and the Head of Quality Control.

So it is the QP's duty prior to release of a batch to ensure that certain pre-requisites are fulfilled as described in § 8 (1) of Annex 16 to the EU GMP Guide:

"Before certifying a batch prior to release the Q.P. doing so should ensure, with reference to the guidance above, that at least the following requirements have been met:

  1. the batch and its manufacture comply with the provisions of the marketing authorisation (including the authorisation required for importation where relevant);

  2. manufacture has been carried out in accordance with Good Manufacturing Practice or, in the case of a batch imported from a third country, in accordance with good manufacturing practice standards at least equivalent to EC GMP;

  3. the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records;

  4. any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system.

Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority;

  1. all the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes;

  2. all necessary production and quality control documentation has been completed and endorsed by the staff authorised to do so;

  3. all audits have been carried out as required by the quality assurance system;

  4. the QP should in addition take into account any other factors of which he is aware which are relevant to the quality of he batch."

There is no requirement in the European regulations and Guidelines that the QP has to approve any other documents than the release documentation.

Chapter 1 of the EU Guide to GMP requires that a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practices and thus Quality Control is in place. It should be fully documented and its effectiveness monitored. The key requirement for QPs according to this Chapter 1 is to ensure that Medicinal Products are not sold or supplied before a QP has certified that the batch has been produced and tested in accordance with the requirements of the marketing authorisation and any other regulations relevant to the production, control and release of medicinal products.
To realise this objective, a QP should be involved in the implementation and maintenance of the Quality (Management) System. However he is not responsible nor is he obliged to implement and run the Quality System.

So if a company has a Quality Control Unit and/or a Quality Assurance Unit with experienced and authorised staff- why should the QP approve controlled documents?

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