| 摘要: | 藥品優良運銷規範 (Good Distribution Practice,GDP)主要針對藥品在儲存及配送過程中，可維持藥品品質與包裝完整性交付至藥局，以供病人使用。GDP條文內容包含品質管理、人事、作業場所及設備、文件管理、作業、申訴、退回、疑似偽、禁藥及藥品回收、委外作業、自我查核、運輸，總計九章。本研究目的為以問卷方式調查桃園市醫藥業者在政府推動GDP政策下是否落實執行規範。
本研究依照業者類別採分層抽樣，並以描述性統計及推論性統計進行資料分析與整理，來評估業者執行GDP成效。綜合分析結果顯示，屬GDP規範對象之117家業者中，僅33.3%業者已取得GDP核准認證，66.7%業者還未取得GDP認證。研究假說經由獨立樣本t檢定、單因子變異數分析與事後檢定驗證，不同業者間執行GDP規範上具有非常顯著差異。
本研究結果顯示未執行規範業者大多數為批發、輸入及輸出須冷鏈儲存與運輸之西藥製劑販賣業藥商，其執行GDP面臨多種困境無法落實完善，建議相關單位應持續追蹤業者執行現況，規劃更完善配套措施協助業者取得核准認證。
Good Distribution Practice (GDP) is mainly to ensure the maintaining the quality and packaging integrity of the drugs during distribution process to the pharmacy for the patient to use. The GDP Guide contain a total of nine chapters including: quality management, personnel, premises and equipment, documentation, operations, complaints, returns, suspected falsified medicinal products and medicinal product recalls, outsourced activities, self-inspections, transportation. The purpose of this study is to research whether the pharmaceutical industry in Taoyuan City implements the GDP Guide under the government's promotion of GDP policy by questionnaire.
This research uses stratified sampling according to the type of operators, and uses descriptive statistics and inferential statistics to analyze and collate data to assess the performance of GDP in the industry. The comprehensive analysis shows that among the 117 companies that are subject to GDP Guide only 33.3% of the operators have obtained GDP approval certification, and 66.7% of the operators have not yet obtained GDP certification. The research hypothesis has a very significant difference in the implementation of GDP Guide between different operators through independent sample t test, analysis of variance and post hoc.
The results of this study show that most of the unaccomplished GDP companies are wholesale, import and export western medicine preparations and drug distributors who need cold chain storage and transportation. Their implementation of GDP faces many difficulties, making it impossible to implement. It is recommended that the relevant departments should continue to track the implementation status of the operators, learn more about the difficulties faced by the operators, planning and improved supporting measures to assist the operators to obtain approval certification. |
