Quality Assurance fundamental concepts

The CGMPs are based on the following fundamental Quality Assurance concepts [1] ... 

The concepts of quality assurance, GMP, and quality control are interrelated aspects of quality management They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products. 

The basic concepts of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are of fundamental importance to the production and control of medicinal products. 

The various GxP regulations used around the world are based on three fundamental concepts of quality assurance (QA) ... 

The basic concepts and fundamentals of most analytical methods are usually first pubhshed in scientific Jomnals— for example. The American Chemical Society pubhca-tions Analytical Chemistry, Environmental Science and Technology, and The Journal of The American Chemical Society. These descriptions are usually brief and often merely summarize the techniques and procedures of the method. Research reported in scientific journal articles is often focused on a detailed investigation of a narrow sub-ject area, and new analytical techniques and procedures developed for the research are rarely tested in a broader context. Analytical quality assurance and control are often minimal or not described. Techniques and procedures described in scientific research journals are the beginnings of analytical methods, but they usually require considerable development, modifications, and testing before they become widely accepted analytical methods. 

Statistics is a fundamental and quantitative component of quality assurance. Statistics is also a powerful tool for the forensic chemist, in that it can describe the accuracy and precision of data, assist in answering h)q)ofliesis-based questions, and identify trends and patterns in data. Statistics and the related tools of probability can be applied to direct sampling and provide a reasonable, defensible, and sensible sampling plan. With such a plan in hand, we are ready to move on to multivariate statistics, calibration, and the unification of these concepts under the umbrella of qualify assurance and qualify control. 

Quality, efficacy, and safety of a medicine are attributes to be planned and established throughout the production process. This concept is especially valid for the production of biologies to assure the fundamental characteristics of efficacy and safety to the patient in each vial of every lot. Every step of pharmaceutical manufacturing should follow high standards intended for production consistency and product quality. The principles defining these standards are described in the Good Manufacturing Practices (GMP) publications. 

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