山東2008年驗證總計劃(編輯修改稿)
2025-02-17 21:49 本頁面
【文章內容簡介】 Co., Ltd. is located in Jinan Export Processing Zone, and the construction start in 2006. Tripardus undertakes manufacturing of products and Nutritional/Vitamin products on a contractual basis. The annual output of tablet will be *** after pletion. The warehouse is *** m2 and the granulation plant is *** m2瑞博德制藥有限公司一期工程位于山東濟南出口貿易加工區(qū)，于2006年開始建設，本工廠根據(jù)與客戶的合同，從事藥品及營養(yǎng)維生素產品的加工。項目建成后，將達到年產量****的片劑生產量，有倉儲系統(tǒng)***平方米，制粒生產車間***，……。 Scope/驗證范圍This plan is to be followed for the validation of plant, purified project, facilities, HVAC, purified water system, pressed air system, production equipment, puterized system, process, cleaning procedures, etc. The validation will prove that the plant meets GMP requirements and is suitable for medicine production.驗證包括本次建設的廠房、凈化工程、倉儲設施、HVAC系統(tǒng)、純化水系統(tǒng)、壓縮空氣系統(tǒng)、生產設備、計算機化系統(tǒng)、加工工藝、清潔程序等，本次驗證后，本次建設的項目應符合GMP要求可以生產藥品。 Validation Policy /驗證方針I(yè)n order to produce the product of right quality, safety and efficacy and ultimately protection of patients, the validation must conform to cGMP and customer requirements. .A planned approach is therefore required in order to progress the work in a structured and controlled manner. Ensure the validation is based on the risk assessment and cGMPrelated critical equipment, process, cleaning, facilities, puterized system and supportive system have been validated. The risk assessment is carried out with protocol establishment simultaneously by Validation Team. The scope and extent of Validation activities for an individual project, based on the conclusions and remendations in the GMP Risk Analysis, and approved by Validation Committee as well as QA Manager.為使瑞博德能生產出合格、安全和有效的產品，最終能保證用戶的健康。驗證應符合cGMP和客戶的驗證要求，驗證工作應有計劃、有組織、有控制的進行，確保驗證建立在風險評估的基礎上，確保與cGMP相關的、有主要作用的關鍵設備、工藝、清洗、設施、計算機系統(tǒng)和支持系統(tǒng)都進行驗證。風險分析由驗證小組成員負責在制定驗證方案時進行，根據(jù)GMP風險分析的結果和建議確定的單個項目的驗證內容和范圍，由包括QA經理在內的驗證委員會在審核驗證方案時批準。 3 Validation Organizational Chart and Personnel Responsibilities/驗證組織結構及人員職責 Organizational Chart/組織結構圖Validation Committee/驗證委員會Validation Manager驗證經理驗證小組（1）Validation Team(1)驗證小組（2）Validation Team(2)驗證小組（3）Validation Team(3)驗證小組（4）Validation Team(4)驗證小組（…）Validation Team(…) Validation Committee/驗證委員會Technical Director is responsible for the whole validation activities。 Validation Manager is responsible for cocoordinating. The Validation Committee is promised of Technical Director, Validation Manager, Production Director, EHS Manager
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