Table of Contents The System of Quality Assurance Quality Assurance Goals Pharmaceutical Quality Assurance (QA) is a continuing process, a state of mind, and a working understanding of the standards and guidelines that apply to the development and manufacture of pharmaceutical products. Quality Assurance is a component of quality management which is committed to ensuring all laboratory operations are carried out in a precise and dependable manner. A drug must be both safe and effective to be approved for marketing. Performance has to be constant and predictable in order to be considered “successful”. Furthermore, QA can be described as the total of all actions and duties necessary to guarantee the drug delivered to the patient is safe and effective. The System of Quality Assurance Quality control, manufacturing, distribution, and inspections are the key areas of responsibility for this department: Quality Assurance ensures the necessary preparations have been made to manufacture, deliver, and use the proper starting and packaging materials. Any…
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