The illiterate of the 21st century will not be those who cannot read and
write, but those who cannot learn, unlearn and relearn.”- Alvin
Toffler.
Pharmaceuticals is a vital sector for any country as it
is directly related to the public right to access affordable medicines
which is an essential commodity. Poor quality medicines not only
jeopardizes human health, but also a waste of money for both governments
and individual consumers. A poor quality medicine can damage health of
consumer as it may contain toxic substances that have been
unintentionally added.
Consumers expect that each batch of
medicines they take will meet all requisite quality standards so that
they will be safe as well as effective. However a consumer usually
cannot detect through smell, touch or sight that a drug product is safe
or if it will work. This is where Good Manufacturing Practices (GMP) and
current Good Manufacturing Practices (cGMP) comes into picture.
The
first time GMP regulations were published by the WHO was in 1968. The
rest of the developed world quickly followed suit, and today there is an
effective, if complex, system of guidelines and alliances that make
possible a high level of quality control and safety in a global
pharmaceutical market.
The evolution of GMP in pharmaceutical
manufacturing may be traced to the 19th century. In 1941, sulphathiazole
tablets were contaminated with phenobarbital resulting in death/injury
of about 300 people which enforced FDA to revise manufacturing and
quality control requirement which gave birth to GMP. Later in 1960/61
the birth of over 10,000 deformed babies by women who consumed
thalidomide during pregnancy ,which shook the entire world , further
highlighted the absence or negligence of a study of proper effects of
new drugs on the next generation.
In early 1970’s the need for
amendments in medical devices was recognized due to pacemaker failures
reported in 1972 & 1973 and thousands of injuries were reported by
use of intrauterine devices. Davenport disaster in which intravenous
fluids were contaminated and killed six people also prompted GMP
regulations.
In 1990, cough syrup contaminated with solvents led
to 47 reported deaths in Nigeria. Between 1986 and 1998 in India and
Bangladesh, paracetamol syrup contaminated with diethylene glycol
resulted in 236 reported deaths, while a similar case of diethylene
glycol poisoning led to 88 reported deaths in Haiti in 1996. These known
and may be many unknown cases as well lead to many positive changes in
the regulations controlling the quality of drug products.
GMPs
are, in general, a quality system that follows certain basic principles.
It is that part of quality assurance which ensures that products are
consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing
authorization. GMPs are aimed primarily at diminishing the risks
inherent in any pharmaceutical production. Such risks are essentially of
two types: cross-contamination (in particular of unexpected
contaminants) and mix-ups (confusion) caused by, for example, false
labels being put on containers.
cGMPs provide for systems that
assure proper design, monitoring and control of manufacturing processes
and facilities. Adherence to the cGMP regulations assures the identity,
strength, quality and purity of drug products by requiring that
manufacturers of medications adequately control manufacturing
operations. This include establishing strong quality management systems,
obtaining appropriate quality raw materials, establishing robust
operating procedures, detecting and investigating product quality
deviations and maintaining reliable testing laboratories. This formal
system of controls at a pharmaceutical company, if adequately put into
practice, helps to prevent instances of contamination, mix-ups,
deviations, failures and errors. This assures that drug products meet
their quality standards.
The cGMP requirements were established
to be flexible in order to allow each manufacturer to decide
individually how to best implement the necessary controls by using
scientifically sound design, processing methods, and testing procedures.
The flexibility in these regulations allows companies to use
modern technologies and innovative approaches to achieve higher quality
through continual improvement. Accordingly, the "c" in cGMP stands for
"current," requiring companies to use technologies and systems that are
up-to-date in order to comply with the regulations. Systems and
equipment that may have been "top-of-the-line" to prevent contamination,
mix-ups and errors 10 or 20 years ago may be less than adequate by
today's standards. While cGMPs require testing, testing alone is not
adequate to ensure quality.
In most instances , testing is done
on a small sample of a batch (for example, a drug manufacturer may test
100 tablets from a batch that contains two million tablets), so that
most of the batch can be used for patients rather than destroyed by
testing. Therefore, it is important that drugs are manufactured under
conditions and practices required by the cGMP regulations to assure that
quality is built into the design and manufacturing process at every
step.
Facilities that are in good condition, equipment that is
properly maintained and calibrated, employees who are qualified and
fully trained and processes that are reliable and reproducible are a few
examples of how cGMP requirements help to assure the safety and
efficacy of drug products. With cGMP came into existence the concept of
Quality Assurance (QA) or zero defect QA advocated that quality cannot
be created at the end of process, instead has to be in-built into a
product at every step of manufacturing process.
The GMP
principles change and develop into more rigorous standards day by day
due to their dynamic nature. Under current GMP rules and regulations, it
is the pharmaceutical manufacturer who is responsible for overall
operations i.e. including the quality of components: the active
ingredient(s), the excipients and the packaging materials. Hence they
have to remain up to date with policy up gradations and advanced
technologies and inventive approaches to make certain that the consumers
receive high quality and safe products.
The customer
satisfaction can be achieved by putting GMP guidelines into practice
which provides necessary guidance to consistently manufacture and offer
for sale safe, efficacious and affordable drug products controlled to
specified quality. Compliance of such GMP regulations results in
maintaining of manufacturing and testing facilities in good condition,
equipment in properly maintained and calibrated state as per defined
schedules, reliable and reproducible processes. Employees engaged in
manufacturing and testing operations would be fully trained and would be
equipped with necessary skills and qualifications.
Considering
these points, GMP guidelines must be put into practice to ensure that
the drug substance is of adequate quality, when used in humans and is
available commercially. Ultimately, quality protects the public and
ensures that the reality of a drug sold or prescribed is an accurate
reflection of the claims and ingredients made not only on the label, but
also of the exact nature of the formulation that was approved through
rigorous clinical trials and analysis. Thus we can say that GMP
guidelines definitely protect consumers and promote public health.
Mrunali R. Patel is faculty Indukaka Ipcowala College of
Pharmacy, New Vallabh
Vidyanagar , Gujarat. Rashmin B.Patel, Jolly R
Parikh and Bharat G. Patel
are faculty A. R. College Of Pharmacy
& G. H. Patel Institute of Pharmacy,
Vallabh Vidyanagar, Gujarat.