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Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes .
CQA are an essential aspect of a manufacturing control strategy and should be identified in stage 1 of process validation: process design. During this stage, acceptable limits, baselines, and data collection and measurement protocols should be established.
The C and C++ programming languages are closely related but have many significant differences. C++ began as a fork of an early, pre-standardized C, and was designed to be mostly source-and-link compatible with C compilers of the time.
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
A Certified Quality Auditor (CQA) is a professional that knows and employs the standards and principles associated with auditing. A CQA is capable of using various evaluation techniques to identify a production system 's strengths and weaknesses in quality control .
The processes and tasks that a quality audit involves can be managed using a wide variety of software and self-assessment tools. Some of these relate specifically to quality in terms of fitness for purpose and conformance to standards, while others relate to Quality costs or, more accurately, to the Cost of poor quality.
Command-query separation is particularly well suited to a design by contract (DbC) methodology, in which the design of a program is expressed as assertions embedded in the source code, describing the state of the program at certain critical times.
For example, (a > 0 and not flag) and (a > 0 && !flag) specify the same behavior. As another example, the bitand keyword may be used to replace not only the bitwise-and operator but also the address-of operator, and it can be used to specify reference types (e.g., int bitand ref = n).