EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Consumer goods
Pharmaceuticals European Medicines Agency
Inspections
London, 20 September 2006
EMEA/INS/GMP/313525/2006
COMPILATION OF COMMUNITY PROCEDURES
ON INSPECTIONS AND EXCHANGE OF
INFORMATION
PUBLISHED ON BEHALF OF THE EUROPEAN COMMISSION
BY EMEA (EUROPEAN MEDICINES AGENCY)
GUIDELINE ON TRAINING AND QUALIFICATIONS OF GMP
INSPECTORS
This document forms part of the Compilation of Community Procedures on Inspections and Exchange of
Information. Please check for updates on the EMEA website (Inspections pages).
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95
E-mail: mail@europa.emea.eu http://www.emea.europa.eu
EMEA 2006 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
EUROPEAN COMMISSION
ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL
Consumer goods
Pharmaceuticals European Medicines Agency
Inspections
GUIDELINE ON TRAINING AND QUALIFICATIONS OF
GMP INSPECTORS
Guideline Title: Guideline on Training and Qualifications of GMP Inspectors
Publisher: European Medicines Agency on behalf of the European Commission
Date of publishing: 1995. Updated February 2004
Responsible authority: Ad hoc GMP Inspection Services
Date of adoption: December 1996. Updated October 2002.
Date of entry into force: May 2004.
Content:
• Basic training
• In-service training
• Continuous training
• Time spent in training
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95
E-mail: mail@europa.emea.eu http://www.emea.europa.eu
EMEA 2006 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is
acknowledged
GUIDELINE ON TRAINING AND QUALIFICATIONS OF GMP
INSPECTORS
1. Introduction
Taking into account the paramount importance of the management of inspection services, this
guideline establishes some requirements concerning experience, training and qualifications of
GMP inspectors.
Objectivity and professional integrity, competence in technical matters and auditing skills should
be the main features of inspectors.
Inspectors should be very well trained in all the relevant topics concerning Quality Assurance
management, manufacturing processes, control and distribution of medicinal products (including
investigational medicinal product in the light of requirements of directive 2001/20/EEC) and in the
way of conducting an inspection (inspection methodology).
The guideline provides information on minimal requirements and is intended to be supplementary
to any national requirements.
2. Scope
This guideline applies to the training and qualifications required for an inspector who shall
conduct an inspection to verify compliance with GMP for the competent authority of the Member
State concerned including inspections on behalf of the Community. The results shall be recognised
by all the other Member States.
3. Background
3.1 General aspects
The Member States should appoint inspectors to inspect the manufacturing sites concerned by
directive 2001/83/EC and directive 2001/82.EC. There should be sufficient resources at all
levels to meet, effectively and efficiently, the EU requirements of verifying compliance with
GMP of medicinal products.
The inspectors shall be officials of or appointed by the competent authorities of the Member
States in accordance with national regulations and follow the provisions for the national
competent authority.
All inspectors should be competent to carry out their assigned duties and receive appropriate
training. When needed teams of inspectors may be nominated comprising inspectors with
appropriate qualifications and experience to collectively fulfil the requirements necessary for
conducting the inspection.
The inspectors should be made aware of and maintain confidentiality whenever they gain
access to confidential information as a result of GMP-inspections according to applicable
national laws, European requirements or international agreements.
There should be sufficient resource to ensure availability of competent inspectors to work
according to contracts between EMEA and the competent authority in the case of inspections
requested by the CPMP.
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The training needs of inspectors should regularly be assessed within the requirements of the
applicable quality system of the Competent Authority/ Inspectorate.and appropriate actions
taken by the competent authority to maintain and improve inspection skills.
Information on the relevant experience, training and qualifications of the individual inspector
must be documented and maintained by the competent authority. These records should be
kept up-to-date.
3.2 Personal qualities
The personal skills of an inspector are important in helping to achieve the objectives of the
inspections.
During an inspection the inspector should help in creating an open atmosphere. Inspectors
need to remain objective during the inspection and in this context should answer questions or
provide clarification but avoid entering into the role of a consultant.
(Delete:The inspectors should be aware of their influence on the decision making process of
the inspectee).
The inspector should have a high personal integrity, maturity, be open-minded, understanding
of complexity, possess sound judgement, assertiveness, analytical skills and tenacity and have
the ability to perceive situations in a realistic way.
The inspector should have demonstrated competence in clearly and fluently expressing
concepts and ideas orally and in writing in their officially recognised language.
1 Education and training
1.1. Education
The inspector should have knowledge of the national legislation as well as systems, national
and within EU, for applications for marketing and control of marketed drugs.
Caution: To be able to act as lead inspector in inspections requested CPMP and co-
ordinated by EMEA and to participate in the ongoing co-operation and harmonisation
of procedures within EU, the inspector should also be able to write and speak English.
4.2 Training
The inspectors should have undergone training to the extent necessary to ensure their
competence in the skills required for planning, carrying out and reporting inspections.
The training and experience should be documented individually and evaluated within the
requirements of the applicable quality system of the Competent Authority/ Inspectorate.
4.2.1 Basic training
They should preferably have the same level of qualification as the "Qualified Person"
as defined in art. 48 of the directive 2001/83/EC, in art.52 of the directive 2001/82/EC
and therefore be eligible as a Qualified Person.
Moreover, in order to be appointed pharmaceutical inspectors, the candidates should
demonstrate their knowledge of the relevant matters in the pharmaceutical field,
including:
− Community Good Manufacturing Practice
− Community and national legislations
− organisation of the national regulatory authority
− structure and principles of operation of commercial organisations
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− marketing and manufacturing authorizations systems and their
relationships
− microbiology, process and ventilation engineering, analytical
instrumentation, computer systems, process validation
− interrelation of inspection, sampling and analysis, licencing
− distribution of medicinal products
− pharmaceutical technology
− auditing techniques
− communication skills, oral and written.
- the general principles of Quality Management Systems (ISO 9000:2000, etc)
- knowledge of the Quality systems of the Competent Authority/Inspectorate
- knowledge of and training in working according to relevant national and
EMEA SOPs for inspections
- knowledge on MRA and PECA
- training in inspection technique, acquired by attending relevant course(s) and/or by
accompanying and/or be guided by qualified GMP inspectors during inspections
- training in administration procedures required for managing an inspection, such as
planning, organising, communicating or providing feed back to inspectee.
-- training in evaluation of findings and reporting
4.2.2 In-service training
After recruitment and in addition to their basic training, new inspectors should be
trained by senior inspectors. The theory of inspection should be explained and the
practice should be shown in the field, so that concrete examples of the meaning and of
the goals of inspections are given and can be discussed. New inspectors should
participate, but only as observers, in on the spot inspections carried out during their
initial training.
Beside this and where needed, training courses in auditing techniques and
communications, reporting, languages, legal matters and management should be
organised by national inspectorates.
4.2.3. Continuous training
Considering the rapid implementation of the manufacturing technologies, the ever
more frequent utilization of automatic and computerized systems both in production
and quality control of medicinal products, inspectors should also receive continuous
training.
This could be reached through their participation in courses, seminars, scientific
meetings and conferences organized either by the national inspectorates or by national
or international scientific organizations.
When appropriate, joint inspections or training visits with other inspectors of the same
Member State or of other Member States may be a useful training method.
Prior to assuming responsibility for performing GMP inspections the new inspector
should have gained experience by participation as team member in inspections led by
senior inspectors. Preferably, the inspector should start with national GMP inspections
as a member of a team and then deal progressively with more complex GMP
inspections to be able to act as a team leader and/or reporting inspector in international
inspections. This should be recorded within the requirements of the applicable quality
system of the Competent Authority/ Inspectorate.
Ten days of training (e.g. courses, symposiums, conferences, etc.) per year should be
considered as a reasonable average
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4.1 Management capabilities
The inspector should through suitable means demonstrate their knowledge and capability of
using the necessary management skills required in execution of an inspection, i.e. planning,
announcing, conducting and reporting an inspection.
4.2 Report writing
The inspector should document and demonstrate their capacity to write inspection reports
according to national requirements as well as according to the EMEA system for inspections
requested by the CPMP or CVMP.
2 Maintenance of competence
Inspectors should have their performance and qualifications periodically reviewed within the
requirements of the applicable quality system of the Competent Authority/ Inspectorate.. Their
competence should be maintained and updated by practical experience and by participating in
courses, seminars, scientific meetings, conferences and review of relevant publications. This
should be documented and its effectiveness assessed
- ensuring that the knowledge of GMP, quality systems standards and requirements is current,
- ensuring that the knowledge of inspection procedures and methods is current
- in quality assurance activities, within the requirements of the applicable quality system of the
Competent Authority/ Inspectorate.
3 Harmonisation within EU
In order to promote international harmonisation in the interpretation of the principles and
compliance, the GMP inspection program management should facilitate training activities,
including on the job training, at national and international levels.
Consultations with the staff of other GMP inspectorates and joint inspections or training visits
may be useful and should be encouraged.
The management should also facilitate the exchange of information and practical experience
gained by inspectors in the fields of GMP, especially in those parts that are closely related to GCP,
e.g. laboratory facilities, computerised data recording and analyses and requirements in relation to
medicinal products for investigational use.
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