THE INTERNAL AUDITORS OF PHARMACEUTICAL QUALITY SYSTEMS COMPETENCE IMPROVING
نویسندگان
چکیده
The importance of internal audits for the pharmaceutical company, which is indicated in guidelines good practices pharmacy (in particular, GMP, GDP).
 issue selection, training, grading, certification and continuous improvement auditor’s competence at companies are relevant important both domestic ones, foreign enterprises.
 aim study was to determine quality system auditors’ areas its development.
 Materials methods. object auditors systems. Empirical theoretical research methods were used, particular method comparative analysis scientific literature field research, structural logical modeling. information basis provisions regulations materials published open professional literature.
 Results. management general consists personal qualities, knowledge skills. ISO 19011 standard highlights evaluating development competence. Such an assessment should take into account needs audit program objectives. Areas auditors' be determined by specifics industry activities. This provision considered companies.
 Conclusions. We studied requirements QMS international standards. A review regulatory framework showed a lack on chosen area research. Defined PQM staff assists selection specialists team so that overall sufficient achieve objectives audit.
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ژورنال
عنوان ژورنال: Eureka: Health Sciences
سال: 2021
ISSN: ['2504-5660', '2504-5679']
DOI: https://doi.org/10.21303/2504-5679.2021.001625