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醫(yī)療器械生產(chǎn)過程確認(rèn)法規(guī)要求

對于生產(chǎn)過程的驗證和或確認(rèn)是確保能夠持續(xù)穩(wěn)定的生產(chǎn)出滿足需求的產(chǎn)品的重要方法。

基本定義

Process Validation: establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

指以客觀證據(jù)確定一個過程持續(xù)地產(chǎn)生的結(jié)果或產(chǎn)品滿足其規(guī)定的規(guī)范。

Installation qualification (IQ): 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. 用客觀證據(jù)證明 設(shè)備被正確安裝，符合制造商批準(zhǔn)的規(guī)范和/或設(shè)備供應(yīng)商建議的規(guī)范。

Operational qualification (OQ): establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.用客觀證據(jù)證明，與產(chǎn)品有關(guān)的過程控制限度范圍符合所有預(yù)先設(shè)定的要求。

Performance qualification (PQ): establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.用客觀證據(jù)證明，在預(yù)期條件下，過程可以連續(xù)地產(chǎn)出符合所有的要求的產(chǎn)品。

法規(guī)的要求

QSR820.75   Process validation.

(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.當(dāng)過程結(jié)果不能通過后續(xù)的檢驗和試驗充分驗證時，過程應(yīng)以高度的保證予以確認(rèn)，并按已確定的程序批準(zhǔn)。確認(rèn)活動和結(jié)果，包括批準(zhǔn)日期和批準(zhǔn)人簽字，以及適當(dāng)時被確認(rèn)的主要裝置，應(yīng)形成文件。

(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.每個制造商應(yīng)為已經(jīng)確認(rèn)的過程的參數(shù)進(jìn)行監(jiān)視和控制建立和保持程序，以確保規(guī)定的要求持續(xù)得到滿足。

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s). 每個制造商應(yīng)確保，經(jīng)確認(rèn)的過程由有資格的人員操作。

(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.對經(jīng)確認(rèn)的過程，監(jiān)視和控制的方法和信息、監(jiān)控日期，以及適當(dāng)時，過程的操作人員或使用的主要裝置，應(yīng)形成文件。

(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.當(dāng)發(fā)生變更或過程偏離時，制造商應(yīng)對過程進(jìn)行評審和評價，適當(dāng)時，進(jìn)行再確認(rèn)。所有這些活動應(yīng)形成文件。

ISO13485（YY/T 0287) Production and Service Provision 

7.5.6 Validation of processes forproduction and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as aconsequence, deficiencies become apparent only after the product is in use or the service has been delivered. 當(dāng)生產(chǎn)和服務(wù)提供過程的輸出不能或不是由后續(xù)的監(jiān)視或測量加以驗證，并因此使問題僅在產(chǎn)品使用后或交付后才顯現(xiàn)時， 組織應(yīng)對這樣的過程進(jìn)行控制。

Validation shall demonstrate the ability of these processes to achieve planned results consistently.確認(rèn)應(yīng)證實這些過程具有穩(wěn)定的實現(xiàn)所策劃的結(jié)果的能力。

The organization shall document procedures for validation of processes, including:組織應(yīng)將過程控制形成文件，過程控制包括：

a)defined criteria for review and approval of the processes; 為過程的評審和批準(zhǔn)所規(guī)定的準(zhǔn)則

b)equipment qualification and qualification of personnel;設(shè)備鑒定和人員資格鑒定

c)use of specific methods, procedures and acceptance criteria;使用特定的方法，程序，和接收準(zhǔn)則

d)as appropriate, statistical techniques with rationale for sample sizes;適當(dāng)時，包括樣本 量原理的統(tǒng)計技術(shù)

e)requirements for records (see 4.2.5);記錄的要求

f)revalidation, including criteria for revalidation;再確認(rèn)，包括再確認(rèn)準(zhǔn)則

g)approval of changes to the processes.對過程整改的確認(rèn)

The organization shall document procedures for the validation of the application of computer software used in production and service provision. Such software applications shall bevalidated prior to initial use and, as appropriate, after changes to such software or its application. Thespecific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of theproduct to conform to specifications. 組織應(yīng)將用于生產(chǎn)和服務(wù)提供的計算機(jī)軟件應(yīng)用的確認(rèn)形成文件。此類軟件的應(yīng)用在首次使用前應(yīng)予以確認(rèn)，適當(dāng)時，此類軟件更改后也應(yīng)進(jìn)行確認(rèn)。有關(guān)軟件確認(rèn)和再確認(rèn)的特定方法和活動應(yīng)與軟件使用的有關(guān)風(fēng)險相適應(yīng)。

Records of the results and conclusion of validation and necessary actions from the validation shall be maintained(see 4.2.4 and 4.2.5).應(yīng)保留確認(rèn)結(jié)果和結(jié)論以及確認(rèn)所采取的必要措施記錄。

China GMP（《醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范》）

第四十六條　*企業(yè)應(yīng)當(dāng)編制生產(chǎn)工藝規(guī)程、作業(yè)指導(dǎo)書等，明確關(guān)鍵工序和特殊過程。

第四十九條　企業(yè)應(yīng)當(dāng)對生產(chǎn)的特殊過程進(jìn)行確認(rèn)，并保存記錄，包括確認(rèn)方案、確認(rèn)方法、操作人員、結(jié)果評價、再確認(rèn)等內(nèi)容。生產(chǎn)過程中采用的計算機(jī)軟件對產(chǎn)品質(zhì)量有影響的，應(yīng)當(dāng)進(jìn)行驗證或者確認(rèn)。