Evolution of quality control in pharmaceutical technologyQuality control QC is a process by which entities review the quality of all factors involved in production. ISO defines quality control as "A part of quality management focused on fulfilling quality requirements". This approach places on a emphasis on three aspects enshrined in standards such as ISO :  . Inspection is a major component of quality control, where physical product is examined visually or the end results of a service are analyzed. Product inspectors will be provided with lists and descriptions of unacceptable product defects such as cracks or surface blemishes for example. Early stone tools such as anvils had no holes and were not designed as interchangeable parts. Mass production established processes for the creation of parts and system with identical dimensions and design, but these processes are not uniform and hence some customers were unsatisfied with the result.
Post a Comment. Home Quality Assurance Quality Control. Difference between Quality Assurance and Quality Control Quality control and quality assurance are two different departments in pharmaceuticals. Both has different identical functions, working and responsibilities.. According to WHO World Health Organization , Quality Assurance QA is a commonly used concept describing how quality matters and influence quality and proficiency of the product, And regarding pharmaceuticals industry, quality assurance can be broken down into the following: Development Quality Control Production Distribution Inspections ISO states that "Portion of quality management mainly focusing on giving confidence where which quality requirements can be fulfilled", And ISO defines quality control as "Another important aspect of quality management system based upon fulfilling quality requirements".
QA refers to the step-by-step process of examining whether goods and services meet specific quality, efficacy and safety requirements, as per their intended use. Defects in pharmaceutical drugs raise the risk of compromising consumer health and potentially human or animal life as well. Effective quality assurance helps organizations build better credibility and consumer confidence, in addition to maintaining adherence to FDA regulations and improving production efficiency and processes. It reduces the chances of negative publicity and impact on sales as well e. Hence, quality assurance in the pharmaceutical industry offers tremendous benefits in terms of rising profits and a stronger reputation.
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QC & QA Department Interview related Question Answer Part 1
Development and Manufacture of Protein Pharmaceuticals pp Cite as. Quality assurance QA and quality control QC play important roles in both assuring compliance to current good manufacturing practices cGMP and ensuring the consistency, quality, and safety of the manufactured drug product. Fortunately, many QA and QC systems are common to different manufacturing processes, such as chemical synthesis, isolation of biologies from natural sources, and production of biopharmaceuticals through recombinant DNA technology or monoclonal antibody hybridoma processes: All involve raw material and component control, facility support, batch record control, process control, product testing, and auditing see Table I. Application of these quality systems throughout the pharmaceutical industry is described in numerous reference books Bryant, ; Peine, ; Sharp, ; Willig and Stoker, Unable to display preview. Download preview PDF.