医疗器械生产过程确认法规要求

对于生产过程的验证和或确认是确保能够持续稳定的生产出满足需求的产品的重要方法。

基本定义

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

指以客观证据确定一个过程持续地产生的结果或产品满足其规定的规范。

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. 用客观证据证明 设备被正确安装，符合制造商批准的规范和/或设备供应商建议的规范。

Operational qualification (OQ): establishing by objective evidence process control limits and action levels which result in product that meets all predetermined requirements.用客观证据证明，与产品有关的过程控制限度范围符合所有预先设定的要求。

Performance qualification (PQ): establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.用客观证据证明，在预期条件下，过程可以连续地产出符合所有的要求的产品。

法规的要求

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.当过程结果不能通过后续的检验和试验充分验证时，过程应以高度的保证予以确认，并按已确定的程序批准。确认活动和结果，包括批准日期和批准人签字，以及适当时被确认的主要装置，应形成文件。

(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.每个制造商应为已经确认的过程的参数进行监视和控制建立和保持程序，以确保规定的要求持续得到满足。

(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s). 每个制造商应确保，经确认的过程由有资格的人员操作。

(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.对经确认的过程，监视和控制的方法和信息、监控日期，以及适当时，过程的操作人员或使用的主要装置，应形成文件。

(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.当发生变更或过程偏离时，制造商应对过程进行评审和评价，适当时，进行再确认。所有这些活动应形成文件。

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. 当生产和服务提供过程的输出不能或不是由后续的监视或测量加以验证，并因此使问题仅在产品使用后或交付后才显现时， 组织应对这样的过程进行控制。

Validation shall demonstrate the ability of these processes to achieve planned results consistently.确认应证实这些过程具有稳定的实现所策划的结果的能力。

The organization shall document procedures for validation of processes, including:组织应将过程控制形成文件，过程控制包括：

a)defined criteria for review and approval of the processes; 为过程的评审和批准所规定的准则

b)equipment qualification and qualification of personnel;设备鉴定和人员资格鉴定

c)use of specific methods, procedures and acceptance criteria;使用特定的方法，程序，和接收准则

d)as appropriate, statistical techniques with rationale for sample sizes;适当时，包括样本 量原理的统计技术

e)requirements for records (see 4.2.5);记录的要求

f)revalidation, including criteria for revalidation;再确认，包括再确认准则

g)approval of changes to the processes.对过程整改的确认

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. 组织应将用于生产和服务提供的计算机软件应用的确认形成文件。此类软件的应用在首次使用前应予以确认，适当时，此类软件更改后也应进行确认。有关软件确认和再确认的特定方法和活动应与软件使用的有关风险相适应。

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).应保留确认结果和结论以及确认所采取的必要措施记录。

China GMP（《医疗器械生产质量管理规范》）

第四十六条　*企业应当编制生产工艺规程、作业指导书等，明确关键工序和特殊过程。

第四十九条　企业应当对生产的特殊过程进行确认，并保存记录，包括确认方案、确认方法、操作人员、结果评价、再确认等内容。生产过程中采用的计算机软件对产品质量有影响的，应当进行验证或者确认。