化粧品製造場所GMP符合性現況調查   全文下載

Survey on the GMP Compliance of Cosmetic Manufacturing Facilities

為確保化粧品製造品質，衛生福利部於108年6月25日公告「應符合化粧品優良製造規範（GMP）之化粧品種類」，化粧品製造場所自113年7月1日起分階段符合GMP，落實化粧品製造品質管理相關要求；衛生福利部食品藥物管理署為推動化粧品製造場所符合GMP，辦理各項說明會與教育訓練等活動，在法規面與技術面提供業者相關資訊，並辦理赴廠輔導／訪視活動，協助業者檢視廠內現況，以利業者進行檢討與規劃改善方案。本研究透過彙整分析赴廠輔導／訪視建議事項及問卷調查等資料，發現國內化粧品製造業者多屬小規模經營、生產劑型種類多樣，在廠房及設施、原料及包裝材料、設備、文件化等事項，針對GMP要求之規劃與落實尚需精進，且多數業者自評尚需2-3年準備期，以符合GMP規範，相關資料可供食藥署持續辦理赴廠輔導／訪視活動之參考，輔導業者加速符合GMP相關規範，確保化粧品製造品質及衛生安全。

To ensure the hygiene, safety, and quality of cosmetic products, the Ministry of Health and Welfare announced on June 25, 2019, that specified cosmetics categories shall comply with the good manufacturing practice in stages by July 1, 2024. To promote GMP compliance TFDA not only organized conference, seminars and training sessions in terms of regulations and technology, but also conducted on-site consultations/visits in order to guide the manufacturers to review the current status and to plan the improvement programs for GMP compliance. Data were collected and analyzed for the common deficiencies found from factory consultations/visits and questionnaires survey. It showed that most domestic cosmetic manufacturers are small business, producing various dosage forms, with insufficient knowledge of legal and technical regulations on premises, raw material management, documentation, etc. The planning and implementation of GMP requirements are yet to be improved, while most companies expected by self-assessment that a 2 to3-year preparation period will be needed to comply with GMP regulations. This information can be used as a reference for TFDA to continuously organize factory consultations/visits so as to guide the industry in accelerating the compliance with GMP-related regulations to ensure the quality and health and safety of cosmetics.