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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).
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.
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 certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
In the 1950s and 1960s, Japanese goods were synonymous with cheapness and low quality, but over time their quality initiatives began to be successful, with Japan achieving high levels of quality in products from the 1970s onward. For example, Japanese cars regularly top the J.D. Power customer satisfaction ratings. In the 1980s, Deming was ...
Homogenization can have adverse effects, for example on proteins, so producers must take care not to over-process materials. [ 9 ] [ 17 ] Stability of a certified reference material is also important, so a range of strategies may be used to prepare a reference material that is more stable than the natural material it is prepared from.
CQA may refer to: CQA Four Mile Bridge, in Hot Springs County, Wyoming; Caffeoylquinic acid, the name of various acids; Certified Quality Auditor, a professional auditor certification; Columbia Queer Alliance, a Columbia University student organization; Community question-answering, in social information seeking