Bringing Updates in the world of Quality
Good Manufacture Practice
Good
manufacturing practice (GMP) is a system for ensuring that products are
consistently produced and controlled according to quality standards. It is
designed to minimize the risks involved in any pharmaceutical production
that cannot be eliminated through testing the final product. The main
risks are:
·
Unexpected contamination of products, causing damage to health or
even death;
· Incorrect labels on containers, which could mean that patients
receive the wrong medicine;
·
Insufficient or too much active ingredient, resulting in
ineffective treatment or adverse effects.
GMP
covers all aspects of production; from the starting materials, premises
and equipment to the training and personal hygiene of staff. Detailed,
written procedures are essential for each process that could affect the
quality of the finished product. There must be systems to provide
documented proof that correct procedures are consistently followed at each
step in the manufacturing process - every time a product is made.
WHO has established detailed guidelines for good manufacturing
practice. Many countries have formulated their own requirements for GMP
based on WHO GMP. Others have harmonized their requirements, for example
in the Association of South-East Asian Nations (ASEAN), in the European
Union and through the Pharmaceutical Inspection Convention.
WHY
IS GMP IMPORTANT?
·
Poor quality medicines are not only a health hazard, but a waste of
money for both governments and individual consumers.
POOR QUALITY MEDICINES CAN
DAMAGE HEALTH
·
A poor quality medicine may contain toxic substances that have been
unintentionally added.
·
A medicine that contains little or none of the claimed ingredient
will not have the intended therapeutic effect.
GMP
HELPS BOOST PHARMACEUTICAL EXPORT OPPORTUNITIES
·
Most countries will only accept import and sale of medicines that
have been manufactured to internationally recognized GMP.
·
Governments seeking to promote their countries' export of
pharmaceuticals can do so by making GMP mandatory for all pharmaceutical
production and by training their inspectors in GMP requirements.
IS GMP
NECESSARY IF THERE IS A QUALITY CONTROL LABORATORY?
·
Yes. Good quality must be built in during the manufacturing
process; it cannot be tested into the product afterwards. GMP prevents
errors that cannot be eliminated through quality control of the finished
product.
·
Without GMP it is
impossible to be sure that every unit of a medicine is of the same quality
as the units of
medicine tested in the laboratory.
CAN
MANUFACTURERS AFFORD TO IMPLEMENT GMP?
·
Yes. Making poor quality products does not save money. In the long
run, it is more expensive finding mistakes after they have been made than
preventing them in the first place. GMP is designed to ensure that
mistakes do not occur.
·
implementation of GMP is an investment in good quality medicines.
This will improve the health of the individual patient and the community,
as well as benefiting the pharmaceutical industry and health
professionals.
·
Making and distributing poor quality medicines leads to loss of
credibility for everyone: both public and private health care and the
manufacturer. WHO works to strengthen GMP.
CAN MANUFACTURERS AFFORD TO IMPLEMENT GMP?
Yes. Making poor quality products does not save money. In the long
run, it is more expensive finding mistakes after they have been made than
preventing them in the first place. GMP is designed to ensure that
mistakes do not occur. Implementation of GMP is an investment in good
quality medicines. This will improve the health of the individual patient
and the community, as well as benefiting the pharmaceutical industry and
health professionals. Making and distributing poor quality medicines leads
to loss of credibility for everyone: both public and private health care
and the manufacturer.
By Mr. Deependra Aggarwal
MBA,LLB
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