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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 .
Critical quality attributes (CQA) are chemical, physical, biological, and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits. [6]
The FDA has outlined a regulatory framework [1] for PAT implementation. With this framework – according to Hinz [2] – the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the ...
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).
Caffeoylquinic acids (CQA) are compounds composed of a quinic acid core, acylated with one or more caffeoyl groups. There is a positive correlation between the number of caffeoyl groups bound to quinic acid and the rate of ATP production. [1] Compounds of this class include: Chlorogenic acid (3-O-caffeoylquinic acid or 3-CQA)
Dogme considers language learning to be a process where language emerges rather than one where it is acquired. Dogme shares this belief with other approaches to language education, such as task-based learning. Language is considered to emerge in two ways. Firstly classroom activities lead to collaborative communication amongst the students.
The C++ Programming Language (1st, 2nd, 3rd, and 4th edition) [26] The Design and Evolution of C++ [27] The Annotated C++ Reference Manual. [28] In all, these books have been translated into 21 languages. [29] More than 100 academic articles, including: Thriving in a crowded and changing world [19] Evolving a language in and for the real world [18]
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