QUALITY
ASSURANCE
Product
quality is the ultimate responsibility of the Quality
Assurance department. At Macter, Quality Assurance
is a service department that supports other departments
as they manufacture and market products, which meet
all the requirements of the Ministry of Health and
other government agencies, as to safety and effectiveness
of the products. Definitives for Quality Assurance
are the internationally recognized standards, which
extend to all areas of activity of the pharmaceutical
production process - from before the purchase of raw
materials until after the delivery of the finished
product to the customer. Ensuring compliance with CGMP,
GLP and GSP, is also the responsibility of this department.
Specifically, Quality Assurance activities cover: Vendor
evaluation; testing and release of raw material, packing
material, intermediate and finished products; facility,
equipment and process validation; documentation control;
and manufacturing and packing procedures.
The Quality Control section is that part of Quality Assurance, which deals with
the sampling and testing of all raw materials, in-process materials and finished
products. It is primarily responsible for testing the stability and perishability
of the products to ensure that they remain safe and effective through their entire
shelf life.
The Research and Development team is involved in the development of formulations
and advanced analytical methodologies and Product improvements & innovations.
Macter carries out in-house research as well as original research programs in
collaboration with the HEJ Research Institute of Chemistry, University of Karachi.