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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 .
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).
Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [1] The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered.
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 .
Title I of the DQSA comprises the Compounding Quality Act (CQA), which amends regulations concerning compounding drugs. Title II, the Drug Supply Chain Security Act (DSCSA), established requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain.
The SEI CERT Coding Standards are software coding standards developed by the CERT Coordination Center to improve the safety, reliability, and security of software systems. [1] [2] Individual standards are offered for C, C++, Java, Android OS, and Perl.
A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines.