From Wikipedia,
the free encyclopedia
Good Manufacturing Practice
is a set of regulations, codes,
and guidelines for the
manufacture of drugs (known as
medicinal products in Europe),
medical devices, diagnostic
products, foods products and
Active Pharmaceutical Ingredients
(APIs).
Since
sampling products will
statistically only ensure that
the samples themselves (and
perhaps the areas adjacent to
where the samples were taken) are
suitable for use, and end-point
testing relies on sampling, GMP
takes the holistic approach of
regulating the production and
laboratory testing environment
itself. An extremely important
part of GMPs is documenting every
aspect of the process, activities,
and of operations. If the
documentation is not correct
and in order, showing how the
product was made and tested, that
allows for
traceability, and recall from
the market in the event of future
problems, then the product is
considered
contaminated (in the US
considered adulterated).
of GMPs is used by
pharmaceutical regulators and the
pharmaceutical industry in over
100 countries worldwide, primarily
in the developing world. In the
European Union, the EU-GMPs, with
more compliance requirements than
those stated in the WHO GMPs are
in force; while in the USA, FDA's
version of GMPs, including
requirements over and above those
stated in the WHO document, are
enforced. Similar forms of GMP are
used in other countries, with
Australia, Canada, Japan,
Singapore and others having highy
developed/sophisticated GMP
requirements.
Since the publication in 1999
by the International Conference on
Harmonization (ICH)
of "GMPs for Active Pharmaceutical
Ingredients", GMPs also apply in
those countries and trade
groupings that are signatories to
ICH (the EU, Japan and the USA)
and other countries who adopt ICH
Guidelines (e.g. Australia,
Canada, Singapore) to the
manufacture and testing of active
raw materials.
Other Good Practices
Other 'Good Practice' systems,
along the same lines as GMP,
exist. "Good
Laboratory Practice" (GLP) for
laboratories conducting
non-clinical studies (toxicology
and pharmacology studies in
animals); "Good
Clinical Practices" (GCP) for
hospitals and clinicians
conducting clinical studies on new
drugs in humans; "Good
Distribution Practices" (GDP)
for wholesalers and distributors.
Collectively these 'Good
Practice' requirements, and others
not mentioned here, are referred
to as 'GxP'
requirements, and all follow
similar philosophies.
Applicable Laws and
Regulations
In the
United States, the FDA or
Food and Drug Administration
sets GMP policy through the
mechanism of the
Federal Register, and numerous
guidelines it releases to
industry. The US GMPs are a
combination of the legislation
(principally
21CFR part 210 and 211),
current industry best practice and
the current FDA thinking, as
expressed in FDA's publications of
Guides and Guidelines, and other
internal FDA documentation such as
Compliance Policy Guides (CPGs)
and sections of the Inspector
Operations Manual (IOM).
Consequently GMP is always moving
ahead as each company improves.
The scope of the US GMPs are
defined in FDA regulations
(21CFR210.1) where it states that
the regulations presented in the
chapter are "the minimum current
GMPs". As such FDA admitted in
1976 when the present set of GMPs
were drafted, that the regulations
are considered to be 'dynamic' and
constantly under change as new
technologies, concepts, or
influences happen. Because of this
the US GMPs are referred to as
'current GMPs' (or cGMPs). Unlike
European or other GMP codes, that
are typically updated and
re-issued every 5-7 years, the US
GMPs have basically remained
unchanged in text for 30 years,
FDA feeling no pressing need to
make revisions, as the "minimum
current" concept applies.
Contrary to many other
countries, FDA's deliberations and
publications, including internal
publications, are subject to the
US Freedom of Information Act,
meaning that almost all the FDA
documents referred to above are
available for downloading on the
internet. A key GMP resource for
the pharmaceutical industry is
FDA Pharmaceutical Industry Web
Portal
In
Europe GMP is defined in
[Commission Directive] 2003/94/EC.
Guidelines have been produced to
assist manufacturers in complying,
these are included in a collection
called Eudralex, available for
downloading from the
EU GMP webpage.
Although each GMP code
world-wide states similar
concepts, there are key
differences. In the GMPs of the
European Union, and of those
countries that are members of the
Pharmaceutical Inspection
Cooperation Scheme (PIC/S),
responsibility for ensuring that
drug products are manufactured in
accordance with the manufacturing
and testing methods registered
with the authorities and that GMPs
have been complied with, rests
with the
Qualified Person (the QP) or
the Responsible Person (RP), who
takes personal, and legal,
responsibility certifying that
each batch of product has been
produced according to the
marketing authorization and GMPs.
In the United States the
responsibilities of the QP are
vested with the company's Quality
Assurance (QA) group.
In Europe and the member
countries of the PIC/S, personal
and legal responsibility for
non-compliance to the marketing
authorization and to GMPs rests
with the QP; who potentially faces
fines and jail sentences for
non-compliance. In the United
States final responsibility, and
potential fines and jail
sentences, rests with the Chief
Executive Office (CEO) of the
company.
