Quality Assurance and Quality Control in Manufacturing Processes
Discover the definitions and importance of quality assurance and quality control in the manufacturing industry. Learn about the role of ISO standards, quality control laboratories, in-process controls, and good manufacturing practices in ensuring product quality.
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Presentation Transcript
Quality Assurance and Quality Control Definitions : 1. Manufacture : - is the complete cycle of production of a desired economically important product. This cycle includes the acquisition of all raw materials, their processing in to a final product and its packaging and distribution. 2. Quality : - Quality is meeting the requirement. - In pharmaceutical industry, the requirements involve meeting specifications and developing
a system to make certain that materials are sampled, tested and evaluated against those specifications. 3. Quality Control [QC] : Quality Control is defined as per ISO 9000 The operational techniques and activities that are used to fulfill requirements of quality - ISO (International Standard Organization) is an organisation that sets international standards. Its standards for quality have been issued as policy-ISO 9000.
- Quality control refers to that part of GMP(Good Manufacturing Practice) ensures that : 1. at each stage of manufacture the necessary tests are made, and 2. the product is not released until it has passed these tests. This tests are performed by Quality Control Laboratory. 4. In-process control : This comprises any test on a product, the environment or the equipment that is made during the manufacturing process.
5. Quality Assurance : Quality assurance is defined as per ISO 9000 All those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality . - Quality Assurance Department oversees the activities of research and development, manufacturing, and quality control. Principles of Quality Assurance : 1. Quality, safety and effectiveness must be designed and built in to the product.
2. Quality can not be inspected or tested in to the finished product. 3. Each step of manufacturing process must be controlled to maximize the probability that the finished product meets all quality and design specifications. - Quality Assurance refers to the sum total of the arrangements made to ensure that the final product if of the required quality, consists of good manufacturing practice plus factors such as original product design and development.
6. Good Manufacturing Practice [GMP]: GMP comprises a part of quality assurance which ensure that the product is consistently manufactured to a appropriate required quality. GMP requires that : (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided.
- In practice, personnel must be trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made.
