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.
Things that need to be considered are:
The QP is linked to a European manufacturing
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.
There is no such thing as a certification to be a
QP. A QP is registered by the authority of the respective EU member
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
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?
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.
Question 3: If a company is based in Switzerland and produces APIs for the
pharmaceutical companies, what are the possibilities for becoming a QP?
As Switzerland is not an EU Member State, the applicable Directives
apply via the MRA.
The QP in Switzerland is called the "Fachtechnisch verantwortliche
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?
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).
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?
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
"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:
the batch and its manufacture comply with the
provisions of the marketing authorisation (including the
authorisation required for importation where relevant);
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;
the principal manufacturing and testing processes
have been validated; account has been taken of the actual production
conditions and manufacturing records;
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;
all the necessary checks and tests have been
performed, including any additional sampling, inspection, tests or
checks initiated because of deviations or planned changes;
all necessary production and quality control
documentation has been completed and endorsed by the staff
authorised to do so;
all audits have been carried out as required by the
quality assurance system;
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
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
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