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Application of statistical process control for spotting compliance to good pharmaceutical practice BJPS
Eissa,Mostafa Essam; Abid,Ahmedy Mahson.
ABSTRACT For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeially. However, statistical process control monitoring is underestimated in most quality control in cases; although it is important not only for process stability and efficiency assessment but also for compliance with all appropriate pharmaceutical practices such as good manufacturing practice and good laboratory practice, known collectively as GXP. The current work aims to investigate two tablet inspection characteristics monitored during in-process control viz. tablet average weight and hardness. Both properties were assessed during the compression phase of the...
Tipo: Info:eu-repo/semantics/other Palavras-chave: Statistical process control (SPC); In-process control; GXP; Film coated tablet; Fluoroquinolone; Capability analysis; Pharmaceutical practice..
Ano: 2018 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000200301
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