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KMID : 1142220110060010107
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.107 ~ p.117
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Comparative Study on ICH Quality Guidelines and Their Related KFDA Regulations
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Jung Yu-Ri
Lee Joo-Hyun
Choi Ji-Young
Cheong Jae-Hoon
Chun In-Koo
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Abstract
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The objective of this research was to compare the International Conference on Harmonisation (ICH) quality (Q) guidelines with related Korea Food & Drug Administration (KFDA) regulations and to propose the regulatory affairs which need to be improved and/or revised. The ICH quality guidelines studied were those for stability testing (Q1), validation of analytical procedures (Q2), impurities in drug substance and products, residual solvents (Q3), general tests and informations for official compendia (Q4), specifications for drug substance and products (Q6A), good manufacturing practices of active pharmaceutical ingredients (API) (Q7), pharmaceutical development (Q8), quality risk management (Q9) and pharmaceutical quality system (Q10). Corresponding national quality-related regulations and guidelines compared were stability testing of drugs and quasi-drugs, guideline on residual solvents in drug substance and drug products, and validation of analytical procedures listed in Korean Pharmacopeia (KP) the Ninth Edition, and Good Manufacturing Practices (GMP) attached in enforcement regulations of drug affairs law, and regulation on review and approval of marketing authorization application. It is suggested from comparative investigation that it is necessary to newly establish user-based, descriptive and detailed guidelines on stability testing, impurities, specifications, and GMP on API, based on ICH quality guidelines, and provide them for the pharmaceutical industry. It is also advised that new evaluation and recommendation of pharmacopeial texts of ICH Q4B annexes should be adopted timely in general tests and general informations of KP. Since appropriate Korean versions of ICH Q10 are not available yet, it is recommended that the relevant guideline will be set in the near future for the global regulatory harmonisation.
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KEYWORD
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ICH quality guidelines, KFDA quality regulations, improvement
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