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KMID : 0370220210650010046
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Yakhak Hoeji
2021 Volume.65 No. 1 p.46 ~ p.55
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An Analysis of the Factors Related to EU GMP Non-compliance - Focusing on Active Substance, Human Medicinal Product -
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Lim Ji-Eun
Cho Hea-Kyoung
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Abstract
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To export medicinal products to Europe, EU Good Manufacturing Practices (GMP) inspection is a critical step. Using the EudraGMDP database from 2009 to 2019, this study was conducted to determine factors influencing noncompliance in the EU GMP inspection. The results revealed that the number of EU GMP inspections has steadily increased in both EU and non-EU countries. The latter showed higher non-compliance rates compared to the former. For active substances, analysis of observations from non-compliance inspections indicated that “Documentation and records,” “Quality management,” and “Equipment” are common items observed as non-compliant. For human medicinal products, “Pharmaceutical quality system,” “Production,” and “Premises and equipment” are frequently observed as non-compliance items. “Building and facilities” and “Contract manufacturing” were found to be significant factors causing GMP qualification failure for active substances. For human medicinal products, “Quality control” was found to be a significant factor in GMP qualification failure. This study confirmed that non-compliance rates for OECD and non-OECD countries were significantly different.
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KEYWORD
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Exports to Europe, EU GMP Certification, Non-compliance, Active Substance, Human Medicinal Product
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