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Quality Control
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The company has employed a group of highly qualified scientists and technicians, referred to collectively as quality control, who examine and check each lot of each product during and upon completion of manufacturing operation for identity, purity, uniformity, and drug content. The responsibilities and procedures applicable to the quality control unit are in writing, such written procedures are followed. The records show the sources of facts and opinions relied upon by the quality control unit in reaching its conclusions. In addition, this group augments its testing functions with continuous auditing of the standard operating procedures, referred to in general as control system. Further, after a product distributed to the market, appropriate tests designed to assure its stability and performances upon exercise of reasonable care in handling are being performed.
Total quality management to achieved the Confirming to W.H.O. – GMP Standards
Total control of quality as it applied organized effort within organization to design, produce, maintain, and assure the specified quality in each unit of product distributed. The efforts are not only to establish specifications for product acceptance but to provide procedures and methods for achieving conformance
with such specification.
The Quality Management Assurance with the help of any other personnel has the responsibility to see that all procedures are as per the standard operating procedures. Personnel’s competence is also assessed by the Quality Assurance Manager. The total Quality Management System is designed for ‘Zero Defect Product
’ for which the Quality Assurance Manager is responsible.
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