Role of Pharmacist in Quality Control Department.
Role of
Pharmacist In the Quality Control Department.
The pharmacist is one of the
important factors in society. He is an
expert in drugs.
He has a
prominent role in the quality control department.
Pharmacists
are deputed in the quality control section where samples for testing are drawn
from raw material, packing material and finished products.
The
pharmacist has a key role in the quality assurance section where the checking
and sampling process is carried out to maintain the quality needed for good
quality practice.
He has also
an important role in the R&D section to discover and develop new products
or raise the standard of existing products.
All the
duties in the quality section are equally important.
Quality
Assurance has a team work with production staff. They are in close touch with
production.
Quality assurance
representative signs the line clearance paper along with the production
representative before the start of the new batch in the manufacturing or
packing section.
During
checking if they observe any anomaly, they make deviation and give it to the
production representative.
They have
the authority to stop production if the anomaly is very serious.
They also
contribute to the investigation of the deviation so that the incident is not
repeated in future.
They have an
important role during the introduction of a new drug or change of material and
facility.
Change
control is also a major part where the change cannot be done in the facility or
material without the consent and approval of a quality assurance representative.
Sample drawn
for testing purposes from finished products is despatched to the quality
control section for testing and then release in the form of a pass label.
Pass label is handed over to
the production pharmacist after
Testing of
raw material, packing material or finished products is through the quality
control pharmacist.
Quality
Assurance pharmacist acts like a bridge between quality control and production
sections.
The quality
assurance pharmacist is responsible for any status of activity related to the
release and testing results.
He is an
expert in using all the machines and equipment used during the testing process.
A
pharmacist's contribution to the research and development department (R&D)
is also significantly important where he is responsible to change control
approval whether there is any change or development of new or existing drugs.
The
pharmacist is a specialized person who has tremendous knowledge about the drugs
therefore is preferred to run the department to increase the GMP of the
concerned department.
The safety
and efficacy of the drug can only be maintained if handed over the process to a
qualified pharmacist.
It is the
responsibility of the quality control pharmacist to arrange testing of the
concerned sample as per the sop and quality method.
The
regulatory department is also related to the quality control department where
the pharmacist is responsible for fulfilment of the requirement of the ministry
of health to avoid many kinds of malpractice.
Most female pharmacists are
interested in the quality and regulatory department may be due to less
dependence on the other contributing factors as compared to the production pharmacists who have to deal with labour for the accomplishment of production targets.
Pharmacist
representing the quality department is equally important and as compared to
production pharmacists both of them strengthen each other to achieve the common
goal of producing the quality products needed for patient recovery.
See Also: Role of Production Pharmacist in Pharmaceutical Industry
Role of Pharmacist in Community Pharmacy.
Role of Pharmacist in Pharmaceutical Marketing.
Written by Javed Aslam (RpH)
Ex. Production Manager GSK Pakistan
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