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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(gè)過(guò)程持續(xù)地產(chǎn)生的結(jié)果或產(chǎn)品滿(mǎn)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(guò)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(guò)程可以連續(xù)地產(chǎn)出符合所有的要求的產(chǎn)品。

 

 

中國(guó)（GMP）有關(guān)生產(chǎn)過(guò)程確認(rèn)的要求

 

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(shū)等，明確關(guān)鍵工序和特殊過(guò)程。

 

第四十九條  企業(yè)應(yīng)當(dāng)對(duì)生產(chǎn)的特殊過(guò)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(píng)價(jià)、再確認(rèn)等內(nèi)容。生產(chǎn)過(guò)程中采用的計(jì)算機(jī)軟件對(duì)產(chǎn)品質(zhì)量有影響的，應(yīng)當(dāng)進(jìn)行驗(yàn)證或者確認(rèn)。

 

美國(guó)（QSR820）有關(guān)生產(chǎn)過(guò)程確認(rèn)的要求

 

(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(guò)程結(jié)果不能通過(guò)后續(xù)的檢驗(yàn)和試驗(yàn)充分驗(yàn)證時(shí)，過(guò)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(dòng)和結(jié)果，包括批準(zhǔn)日期和批準(zhǔn)人簽字，以及適當(dāng)時(shí)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(gè)制造商應(yīng)為已經(jīng)確認(rèn)的過(guò)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(mǎn)足。

 

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s). 

每個(gè)制造商應(yīng)確保，經(jīng)確認(rèn)的過(guò)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(duì)經(jīng)確認(rèn)的過(guò)程，監(jiān)視和控制的方法和信息、監(jiān)控日期，以及適當(dāng)時(shí)，過(guò)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(guò)程偏離時(shí)，制造商應(yīng)對(duì)過(guò)程進(jìn)行評(píng)審和評(píng)價(jià)，適當(dāng)時(shí)，進(jìn)行再確認(rèn)。所有這些活動(dòng)應(yīng)形成文件。

 

國(guó)際（ISO 13485）有關(guān)生產(chǎn)過(guò)程確認(rèn)的要求

 

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(guò)程的輸出不能或不是由后續(xù)的監(jiān)視或測(cè)量加以驗(yàn)證，并因此使問(wèn)題僅在產(chǎn)品使用后或交付后才顯現(xiàn)時(shí)， 組織應(yīng)對(duì)這樣的過(guò)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(shí)這些過(guò)程具有穩(wěn)定的實(shí)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(guò)程控制形成文件，過(guò)程控制包括：

 

a) defined criteria for review and approval of the processes;

為過(guò)程的評(píng)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(shí)，包括樣本量原理的統(tǒng)計(jì)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(duì)過(guò)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(jì)算機(jī)軟件應(yīng)用的確認(rèn)形成文件。此類(lèi)軟件的應(yīng)用在首次使用前應(yīng)予以確認(rèn)，適當(dāng)時(shí)，此類(lèi)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(dòng)應(yīng)與軟件使用的有關(guān)風(fēng)險(xiǎn)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。

 

醫(yī)療器械生產(chǎn)過(guò)程確認(rèn)的實(shí)踐：

 

1、生產(chǎn)工藝流程確認(rèn)，包括特殊工序和關(guān)鍵工序的識(shí)別，及過(guò)程輸出-參數(shù)的定義

 

2、基于工藝流程的輸出考慮失效模式，并制定相約的控制措施及在后續(xù)過(guò)程驗(yàn)證、確認(rèn)中實(shí)施和監(jiān)控。

 

3、制定確認(rèn)主計(jì)劃，用于統(tǒng)籌確認(rèn)，驗(yàn)證的所有活動(dòng)（對(duì)于每一個(gè)驗(yàn)證子活動(dòng)，制定驗(yàn)證方案并按照方案實(shí)施驗(yàn)證），并定義再確認(rèn)的準(zhǔn)則。所有驗(yàn)證，確認(rèn)活動(dòng)完成后，整理確認(rèn)主報(bào)告。