开题报告内容：（包括拟研究或解决的问题、采用的研究手段及文献综述，不少于1500字）
- Purpose of Quality monitoring
There are three basic principles of Quality Assurance which must be designed and built into the production: quality, safety, and effectiveness. Quality cannot be inspected or tested into the finished products. Each steps of the manufacturing process must be controlled to maximize the probability that the finished products meet all quality and design specifications.
What Quality Assurance personnel aim at is to ensure that the products are manufactured in accordance with the registration requirements and the final drug products are of consistent quality by minimizing the risks of contamination, cross-contamination and mix-ups or errors in manufacturing process.
Quality Assurance is a significant part of the quality management system. The manufacturer should found Quality Assurance system with the support of a complete documentation system to ensure its effective operation. Quality Assurance monitoring covers the entire life cycle of drug products. Quality management department should perform in accordance with the appropriate written specifications. If something what can adversely affect the component, drug product containers or closures happened, the causes of defects should be investigated and appropriate actions shall be taken actually. Also, remedial methods are supposed to be exercised to prevent a reoccurrence of the problem.
- Methods
By reviewing literature, and the most advanced knowledge about the Good Manufacturing Practices(GMP) domestic and overseas, combining with the internship in NOVAST, with the guidance of director teacher and senior, I will finish the papers Quality monitoring during in-process quality assurance.
- Content
Any untested components shall be examined visually before acceptance and be stored under quarantine, and cannot be released to use by quality control unit until sampled, tested or examined.
Next, the untested components shall be sampled based upon criteria, such as component variability, confidence levels, degree of precision desired, the past quality history of the supplier, and the quantity needed for analysis in accordance with the appropriate written specifications.
Finally, any lot of the components that meets the specifications or even with some temporary and appropriate deviation shall be approved. And the rejected things will be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations.
However, before put into production, if something what can adversely affect the components, a retest or reexamination shall be conducted as appropriate to decide whether approve or reject.
The procedures for production and process controls are designed to assure that the consistent quality of drug products and are executed in the performance. They include personnel qualification, equipment qualification, raw materials and purified water qualification, heat ventilation air conditioning system (HVAC), process validation, sampling and testing，deviation handling and finished product released, and so on. All of these set forth are aimed at assuring the consistent quality of the final drug products.
