GMP ISO 22716 GMP-IMPLEMENTATIONh24-files.s3.amazonaws.com/13147/38300-hS9oC.pdf · GMP IN...
Transcript of GMP ISO 22716 GMP-IMPLEMENTATIONh24-files.s3.amazonaws.com/13147/38300-hS9oC.pdf · GMP IN...
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GMP-IMPLEMENTATION
GMP ISO 22716
IRENA OZGA
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GMP -IMPLEMENTATION
Topics to cover:
cGMP norm ISO22716 and cGMP
related legislation
Pros and cons of GMP implementation
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GMP IN COSMETICS
Relevant documents:
GMP ISO EN 22716:2007
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
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GMP ISO 22716
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GMP ISO 22716
GMP ISO 22716:
COSMETICS- GOOD MANUFACTURING
PRACTICES -GUIDLINES ON
MANUFACTURING PRACTICES
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GMP ISO 22716
ISO 22716 consists of 17 chapters
that define different areas
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GMP ISO 22716
GMP ISO 22716 gives guidelines for
production, control, storage and
shipment of cosmetic product.
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GMP ISO 22716
GMP ISO 22716 is not applicable to
research and development activities
and distribution of finished product.
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GMP ISO 22716
But.....also involves other departments or parts
6.2 Purchasing
Purchasing of raw materials and packaging materials should be based on:
a) evaluation and selection of the supplier;
(...)
c) setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits.
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GMP ISO 22716
ISO 22716 norm does not cover
personel safety issues nor the
environmental protection area
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GMP ISO 22716
GMP ISO 22716 norm is:
-designed for cosmetic industry and
differs from pharmaceutical GMP
-guidelines that give some possibilities
of different interpretation
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GMP ISO 22716
Guidelines:
‘The water treatment system should
supply a defined quality of water’
‘Ventilation should be sufficient for the
intended production operations’
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GMP ISO 22716
Guidelines:
‘Adequate facilities for showering
and changing clothes should be
provided when appropriate’
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GMP ISO 22716
Why GMP ISO 22716????
ISO norms are not mandatory.......
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REGULATION NO 1223/2009
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REGULATION NO 1223/2009
No 1223/2009 article 8 about Good
Manufacturing Practice:
1.The manufacturing of cosmetics
shall comply with good manufacturing
practice with a view of ensuring the
objectives of Article 1 (safety of
cosmetic product and human health)
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REGULATION NO 1223/2009
No 1223/2009 article 8 about Good
Manufacturing Practice:
2.Compliance with good
manufacturing practice should be
presumed where the manufacture is
in accordance with relevant
harmonized standards
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GMP IN COSMETICS
A harmonized standard will provide
benchmark criteria for the mandatory
good manufacturing practice.
However, other standards or systems
providing at least an equivalent level
of GMP could be used.
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GMP IN COSMETICS
This standard is expected to be EN ISO
22716:2007 Cosmetics - becoming
harmonized when its reference is
published in the EU''s Official
Journal. It has already been
transposed as a national standard in
several Member States.
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GMP IN COSMETICS
GMP in compliance with the
harmonized ISO 22716 will offer a
presumption of conformity to the GMP
requirements.
While compliance with ISO 22716 is not
mandatory, its harmonized status
offers the simplest option.
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IMPLEMENTATION OF ISO 22716
PROS AND CONS
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IMPLEMENTATION OF ISO 22716
stay in line with legal requirements
define and link all important processes
simplify of work flow
increase of effectiveness /capacity
build up efficient QA system
significant raise of product quality
POSITIVES
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IMPLEMENTATION OF ISO 22716
increase personnel responsibility for
product and production environment
better routines for problems handling
more competitive on the market
good base to implement ISO 9001
standard
POSITIVES
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IMPLEMENTATION OF ISO 22716
requires good knowledge of norm and of
internal processes
wrong interpretations lead to wrong
system
might be expensive due to investments in
changing or rebuilding the premises
DIFFICULTIES
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IMPLEMENTATION OF ISO 22716
difficult to change personnel approach
change control implementation
DIFFICULTIES
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GMP IN COSMETICS
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TACK SÅ MYCKET!!!!