19/10/2021
New Post: 製程確效 Process Validation http://172.104.179.229/2021/10/19/%e8%a3%bd%e7%a8%8b%e7%a2%ba%e6%95%88-process-validation 確認某段製程透過特殊管制使製程結果（產品、服務、或其他的輸出）可以得到保障以持續符合預期要求。
提要 Summary
許多注重品質及品質系統的醫療器材公司, 已開始進行及實施製程確效的作業。透過製程確效流程不僅能掌握醫療器材產品品質, 並可減少全檢的負擔。
如何辨別需確效的製程, 並透過說明充分熟悉製程確效的概念及其做法，進一步為公司帶來品質及品質系統運作之效益。
大綱
1.Terminology, standard and regulations 術語、標準和法規
製程確效是在醫療器材常用到的名詞，大意是：
製程確效建立客觀的證據來確認製程，使用特別的管制方法使製程結果（成品，半成品或其他的輸出）可以達到持續穩定，並符合預期的要求。
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
FDA 21 CFR 820.3, Definitions (https://buff.ly/3jaooOX)
製程確效一般包含「計畫建立、搜集資料、解讀資料」的流程，流程一般分為以下三階段（稱為 3Q）：
IQ (Installation qualification) 安裝驗證
通過客觀證據證明過程設備和輔助系統安裝的所有參數方面都符合製造商批准的規範，並且適當使用設備供應商的建議。目的：設備正確
Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.1
OQ (Operational qualification)操作驗證
通過客觀證據, 建立過程控制的範圍（參數上下限），確定CAPA矯正預防行動的時機，從而使產品滿足所有預定要求。目的：參數範圍正確
Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.2
PQ (Performance qualification)性能驗證
通過客觀證據確定該過程在預期條件下始終如一地生產出滿足所有預定要求的產品。
Establishing by objective evidence that the process, under
anticipated conditions, consistently produces a product which meets all predetermined requirements.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.3
Process validation protocol:
Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.5
Verification:
Confirmation by examination and provision of objective evidence that the
specified requirements have been fulfilled.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.6
2.When is process validation required? 何時需要製程確效
3.Different types of process validation 不同的製程確效類型
4.An introduction to process capability studies 製程能力研究
5.Process validation protocols (IQ, OQ and PQ) 製程確效計畫書
6.Monitoring the state of process validation 監督製程確效狀態
7.Process revalidation 製程重新確
確認某段製程透過特殊管制使製程結果（產品、服務、或其他的輸出）可以得到保障以持續符合預期要求。
提要 Summary
許多注重品質及品質系統的醫療器材公司, 已開始進行及實施製程確效的作業。透過製程確效流程不僅能掌握醫療器材產品品質, 並可減少全檢的負擔。
如何辨別需確效的製程, 並透過說明充分熟悉製程確效的概念及其做法，進一步為公司帶來品質及品質系統運作之效益。
大綱
1.Terminology, standard and regulations 術語、標準和法規
製程確效是在醫療器材常用到的名詞，大意是：
製程確效建立客觀的證據來確認製程，使用特別的管制方法使製程結果（成品，半成品或其他的輸出）可以達到持續穩定，並符合預期的要求。
Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
FDA 21 CFR 820.3, Definitions (https://buff.ly/3jaooOX)
製程確效一般包含「計畫建立、搜集資料、解讀資料」的流程，流程一般分為以下三階段（稱為 3Q）：
IQ (Installation qualification) 安裝驗證
通過客觀證據證明過程設備和輔助系統安裝的所有參數方面都符合製造商批准的規範，並且適當使用設備供應商的建議。目的：設備正確
Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.1
OQ (Operational qualification)操作驗證
通過客觀證據, 建立過程控制的範圍（參數上下限），確定CAPA矯正預防行動的時機，從而使產品滿足所有預定要求。目的：參數範圍正確
Establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.2
PQ (Performance qualification)性能驗證
通過客觀證據確定該過程在預期條件下始終如一地生產出滿足所有預定要求的產品。
Establishing by objective evidence that the process, under
anticipated conditions, consistently produces a product which meets all predetermined requirements.
GHTF/SG3/N99-10:2004 (Edition 2) (https://buff.ly/30G4MMc), Definitions 2.3
Process validation…
確認某段製程透過特殊管制使製程結果（產品、服務、或其他的輸出）可以得到保障以持續符合預期要求。 提要 Summary 許多注重品質及品質系統的醫療器材公司, 已開始進行及實施製程確效的作業。透過製程確效流程不僅能掌握...
