化粧品品質與品質保障事件不斷增加，使得世界各國對化粧品管理已趨向於加強上市後管理、全球法規一致化及有關製造之品質管理和品質保障等方面發展。歐盟及東協已率先推動化粧品優良製造(GMP, Good Manufacturing Practices)，以提升及確保化粧品之既定品質於持續恆定，並保障消費者之安全；馬來西亞也已頒佈了化粧品優良製造規範，並開始推動化粧品GMP。由此可知化粧品優良製造乃是目前國際趨勢。本計畫擬參考國外化粧品GMP推動現況與國內藥品及食品等產業GMP推動情形，提出國內推動與建構化粧品GMP相關機制之建議與參考，以健全我國現有化粧品管理法規與保障國人安全。本年度計畫將規劃國內化粧品GMP法規建置、查廠作業及審查機制。研究過程如下： 1. 先期預備作業： (1) 組織專家委員會，成員包括產官學代表，其職責為： (a) 研究方針之確定； (b) 商議由工作小組提出之各種起草或建議案； (c) 結案前審定各項草案及研究結果。 (2) 組織工作小組，其職責為： (a) 起草各書面建議文件，包括將來實施時之時程策略； (b) 由指定專人執行本案之品管及品保作業； (c) 其他本案相關事務。 2. 起草化粧品GMP法規建置、查廠作業及審查機制。 (1) 化粧品優良製造規範草案：以國外化粧品GMP推動現況包括法規，與國內藥品及食品等產業GMP法規和指引等為主要參考。 (2) 編輯下列文件供3(4)節所述之赴廠溝通、瞭解與試驗性輔導： Site Master Files (SMF), Quality Policy Manual, GMP 有關之各種SOPs 包括確效及品保制度之建立等。 3. 業界溝通及舉辦起草前公聽會與結案前之說明會： (1) 與化粧品有關公會討論我國化粧品GMP 事宜； (2) 舉辦起草前公聽會，並討論新制度修訂方向； (3) 舉辦結案前之說明會，報告研究初步結果及徵求意見； (4) 至少訪問五家工廠，進行現場討論與溝通與必要之協助輔導。 4. 結案時呈送化粧品GMP有關之各種規範及建議。 依招標單位之設計，本計畫為一年期計畫，但由研究小組之經驗，宜改為多年計畫以落實推行。 With the increasing numbers of events of quality and safety problems, more stringent control of the cosmetic industry has been a major issue that post-marketing surveillance, international harmonization of the regulations regarding the inspection as well as the quality management and the quality assurance in the manufacturing have gained international focusing to protect the safety of the cosmetic vast users. The cosmetic good manufacturing practice (GMP) has been implemented in countries of European Union and the ASEAN. A guidance of such GMP has been established in Malaysia. The purpose of the corresponding GMP is to ensure the quality of the respective cosmetic consistently at the pre-established quality level. In accordance with the international trendd on the control of the quality of cosmetic products and to protect the cosmetic users of our country, we propose to work on this initiative to establish a draft of a Guidance on the GMP for our cosmetic industry as well as an inspection and auditing system operated by the responsible government agencies. The study will focus on the following subjects: 1. Preparatory works. (1) organization of an expert committee consisting of experts from industry, government agencies and academics. The duties of this committee are: (a) policy establishment; (b) approval or dispproval of drafts prepared by the task group. (c) Formalizaing draft proposals before concluding this project. (2) Organization of a task forcefor: (a) drafting of all written proposals indluding the time schedule of the formal implementation by the government agencies; (b) quality control and quality assurance of this project operated by a designated person. 2. Drating of GMP guidance and system for inspection and auditing operated by the responsible government agencie by the task group. (1) The draft proposal of the GMP guidance will be prepared by using the existed related regulations of our country and the existed international guidances and regulations as key references. (2) Drafting of templates of the followings that will be used in the site visiting described in 3(4): Site Master Files (SMF), Quality Policy Manual, SOPs for GMP operations including validation and quality assurance. 3. Public hearings before the drafting and the final formalization of the draft guidance and other proposals. (1) Discussion of the GMP issue with the local cosmetic industry association; (2) A public hearing on the general idea regarding the direction of the drafting; (3) A public hearing or conference for the drafted GMP proposals before the formalization. (4) Site visiting for discussions with individual factories. A minimum of five factories will be visited. 4. Formalization of the GMP draft and other proposals. The investigators suggest, at this stage, though this project is pre-established as a one year program, that to allow the industry to practice sound GMP further projects should be established in next two years for the GMP training/education by class works, conferences and on site visiting for the implementation of GMP and the establishment of QA system in each factory.
