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Article 3
Definitions
For the purpose of this Regulation, the following definitions
shall apply:
(a)
`good manufacturing practice (GMP)' means those aspects of
quality assurance which ensure that materials and articles
are consistently produced and controlled to ensure
conformity with the rules applicable to them and with the
quality standards appropriate to their intended use by not
endangering human health or causing an unacceptable
change in the composition of the food or causing a de-
terioration in the organoleptic characteristics thereof;
(b)
`quality assurance system' means the total sum of the
organised and documented arrangements made with the
purpose of ensuring that materials and articles are of the
quality required to ensure conformity with the rules
applicable to them and the quality standards necessary for
their intended use;
(c)
`quality control system' means the systematic application of
measures established within the quality assurance system
that ensure compliance of starting materials and inter-
mediate and finished materials and articles with the specifi-
cation determined in the quality assurance system;
(d)
`non-food-contact side' means the surface of the material or
article that is not directly in contact with food;
(e)
`food-contact side' means the surface of a material or article
that is directly in contact with the food.
Article 4
Conformity with good manufacturing practice
The business operator shall ensure that manufacturing
operations are carried out in accordance with:
(a) the general rules on GMP as provided for in Article 5, 6,
and 7,
(b) the detailed rules on GMP as set out in the Annex.
Article 5
Quality assurance system
1.
The business operator shall establish, implement and
ensure adherence to an effective and documented quality
assurance system. That system shall:
(a) take account of the adequacy of personnel, their knowledge
and skills, and the organisation of the premises and
equipment such as is necessary to ensure that finished
materials and articles comply with the rules applicable to
them;
(b) be applied taking into account the size of the business run
by the operator, so as not to be an excessive burden on the
business.
2.
Starting materials shall be selected and comply with pre-
established specifications that shall ensure compliance of the
material or article with the rules applicable to it.
3.
The different operations shall be carried out in accordance
with pre-established instructions and procedures.
Article 6
Quality control system
1.
The business operator shall establish and maintain an
effective quality control system.
2.
The quality control system shall include monitoring of the
implementation and achievement of GMP and identify measures
to correct any failure to achieve GMP. Such corrective measures
shall be implemented without delay and made available to the
competent authorities for inspections.
Article 7
Documentation
1.
The business operator shall establish and maintain appro-
priate documentation in paper or electronic format with respect
to specifications, manufacturing formulae and processing which
are relevant to compliance and safety of the finished material or
article.
EN
L 384/76
Official Journal of the European Union
29.12.2006