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Introduction
This
Guideline for Good Manufacturing Practices inspection for the pharmaceutical industry was prepared by the APSO Group on Good
Manufacturing Practices (APSO/GMP) which addresses the
requirements of the WHO Technical Report on Good Manufacturing
Practices # 32 and the particular considerations of all members of
the APSO Group.
The
Guideline is published in the ALAPSO web page (www.alapso.org) to
promote participation and discussion by institutions and
professional experts in this topic. This will give all those who
are interested, the opportunity to send suggestions, comments, or
to simply give their opinion. The Guideline remained in the web
page since October, 2006 in order to receive comments and others
input.
The APSO/GMP working group will review and analyze all the comments
received and prepare this revised version of the Regional
Guideline of GMP inspection for the Afro- Arab Countries which are
submitted for Consideration to the Arab Ministers of Health
Some
of the advantages of the Guideline are:
1-
the Guideline will help to
establish the standards for GMP inspections:
2-
it will be more
comprehensive than what is in place in the economic blocks (
countries ) and will send the message that countries need to work
as a community to meet established standards, and therefore,
improve the quality of pharmaceutical products,
3-
It will serve as a work
model necessary for common criteria.
4-
It should not be used as a
check list, but it should show principles important to consider in
association with an inspection,
5-
It can be used as a training
document for GMP inspections, and
6-
It will be helpful to
countries in educating inspectors with unified criteria.
TABLE
OF CONTENTS
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