| Drugs
being a very important component of healthcare, these
need special attention especially with respect to
quality, efficacy and safety. This has always been
a matter of concern from the consumer point of view.
The quality control concept basically meant that the
quality of the product conformed to the predetermined
standards as given in the pharmacopoeia. But the concept
was not enough as thereafter the concept GMP emerged
in the 1960s in USA. It was however the WHO who played
a major role in bringing awareness to the manufacturer
of the drug product and national drug regulatory authorities
through its certification scheme. The setting of global
standard is required by WHO constitution. One of the
organization function is that it should "develop,
establish and promote international standard with
respect to food, pharmaceutical and similar products".
Responsibility of assuring
product quality belongs principally to quality assurance
personnel but involves team effort. The manufacturer
fulfills his obligation to the consumer by following
good manufacturing practices, which ensure that a
product consistent high quality is manufactured by
him every time. Good manufacturing starts from the
time raw material enters the factory and continues
into the final dosage form and takes care that it
is delivered safely into the hands of consumer.
In the recent past pharmaceutical
manufacturing organizations world over have devoted
a great deal of effort (resources) to ensure compliance
with cGMP guidelines issued by licensing authorities.
The Indian pharmaceutical industry in particular has
demonstrated remarkably its ability to comply with
the stringent requirements of regulatory authorities
like the USFDA and UKMCA, etc. Still except for multinational
companies and a few other pharmaceutical companies,
GMP did not percolate to a large number of medium
and small-scale pharmaceutical companies.
In the view of change
which is taking place Indian pharmaceutical industry;
to stand in the global market, Quality assurance department
is set to help the students to learn and understand
the concepts of cGMP, GCP, GLP, etc. and implement
them successfully to industry. |