改建評估工程
Assessment of facility & utilities including Cleanroom, HVAC, CDA, vacuum, dust
extraction, waste water, plant steam, electricalsAssessment on current design, operability, maintainability, cross contamination risk, and
upgradability
Retrofitted into an old facility on a tight footprint, the original production area design needed work-arounds and compromises in order to comply to GMP requirements. The company is expecting incoming technology transfer of new products, subject to updated regulatory requirements. In order to make sure the facility can be upgraded to accept the new products, and to assess the engineering risks involved, PharmEng conducted a review of the existing conditions of the facility and utilities, considering GMP design, operability, maintainability, cross contamination risk, and upgradeability.
| 地點： | 南投 |
|---|---|
| 產品生命週期： | ⛝ 臨床前 ⛝ 臨床 ☑ 上市前 ⛝ 上市後 |
| 廠房生命週期： | ☑ 可行性評估 ⛝ 概念設計 ⛝ 細部設計 ⛝ 施工 ⛝ 驗證 ☑ 確校 ⛝ 生產 |
| 法規目標： | US FDA、EU EMA、PIC/S GMP |
| 專案架構： | ☑ 顧問 ⛝ 統包 ⛝ 下包 ⛝ 專案管理 |
| 產品類別： | ☑ 西藥（小分子） ⛝ 西藥（生物） ⛝ 原料藥 ⛝ 動物用藥 ⛝ 中藥 ⛝ 化妝品 ⛝ 健康食品 ⛝ 食品 ⛝ 醫療器材 |
| 製程（原料）類別： | ⛝ 萃取 ⛝ 化學反應 ⛝ 細菌培養 ⛝ 細胞培養 ⛝ 病毒培養 |
| 製程（製劑）類別： | ☑ 口服錠劑 ⛝ 口服液體 ⛝ 粉狀 ☑ 膠囊製劑 ⛝ 注射劑 ⛝ 凍乾 ⛝ 無菌 ⛝ 貼片 |
