GHTF/SG3/N99-10:2004 (Edition 2)
FINAL DOCUMENT
Title: Quality Management Systems - Process
Validation Guidance
Authoring Group: SG3
Endorsed by:The Global Harmonization Task Force Date:  Edition 2 - January 2004
Taisuke Hojo, GHTF Chair
The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry.  The document is intended to provide n on-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use o f this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
GHTF Study Group 3 - Quality Management Systems
Process Validation Guidance – January 2004
Page 2
Process Validation Guidance Contents
0 Introduction
1 Purpose and scope
1.1 Purpose
1.2 Scope
2 Definitions
3 Processes that should be validated
3.1 Special processes
3.2 Process validation within the quality management syste m
3.3 Process validation decision
documented evidence
3.4 Examples
4 Statistical methods and tools for process validation
5 Conduct of a validation
5.1 Getting started
5.2 Protocol development
5.3 Installation qualification (IQ)
5.4 Operational qualification (OQ)
5.5 Performance qualific ation (PQ)
6 Maintaining a state of validation
6.1 Monitor and control
6.2 Changes in process and/or product
6.3 Continued state of control
6.4 Examples of reasons for revalidation
7 Use of historical data in process validation
8 Summary of activities
Annexes
A Statistical methods and tools for process validation
B Example validation
GHTF Study Group 3 - Quality Management Systems
Process Validation Guidance– January 2004
Page 3 0Introduction
“Quality Management Systems – Process Validation Guidance”, originally finalized in 1999, is being
republished as “GHTF/SG3/N99-10:2004 (Edition 2)” after revisions due to the changes in ISO 13485:2003, which is utilized in some regulatory systems.  The Process Validation Guidance has been
revised in sections 0 through 3.4, Figure 1 and Annex B.  The revisions can be generalized in two
categories:  1.) Editorial revision of terminology to be consistent with ISO 13485:2003 (i.e., “quality system” to “quality management system” and “design controls” to “design and development controls”), and; 2.)  Changes to Figure 1 and the corresponding text to reflect the new process validation requirements found in clause 7.5.2 of ISO 13485:2003.
This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation and has general applicability to manufacturing (including servicing and installation) processes for medical devices.  The guidance provides general suggestions on ways manufacturers may prepare for and carry out process validations.
Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed.  This is vitally important if the predetermined requirements of the product can only be assured by destructive testing.
Processing deficiencies may only become apparent after an intermediate component is further process
ed or the finished product is in use.  Validation of a process entails demonstrating that, when a process is operated within specified limits, it will consistently produce product complying with predetermined (design and development) requirements.
The medical device industry encompasses a wide range of technologies and applications, ranging from simple hand tools to complex computer-controlled surgical machines, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment.  These devices are manufactured by companies of varied size, structure, volume of production, manufacturing processes and management methods.  These factors, especially production volume and number of manufacturing steps per unit (e.g. soldering or welding steps) significantly influence how process validation is actually applied.  Given this diversity, this guidance does not suggest particular methods of implementation, and therefore, must not be used to assess compliance with quality management system requirements.  Rather the intent is to expand on quality management system requirements with practical explanations and examples of process validation principles.  Manufacturers can and should seek out/select technology-specific guidance on applying process validation to their particular situation.
This guidance provides general suggestions on ways manufacturers may prepare for and carry out pro
cess validations.  Other ways may be equally acceptable; some regulatory requirements place the responsibility on the manufacturer to specify those processes which require validation and the qualification of personnel who operate validated processes.  Regardless of the method used to validate the process, records of all validations activities should be kept and the final outcome documented.
While the completion of process validation is a regulatory requirement, a manufacturer may decide to validate a process to improve overall quality, eliminate scrap, reduce costs, improve customer satisfaction, or other reasons.  Coupled with properly controlled design and development activities; a validated process may well result in a reduced time to market for new products.
In general, the validation of a process is the mechanism or system used by the manufacturer to plan,
GHTF Study Group 3 - Quality Management Systems
Process Validation Guidance – January 2004
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obtain data, record data, and interpret data.  These activities may be considered to fall into three phas
es: 1) an initial qualification of the equipment used and provision of necessary services – also know as installation qualification (IQ); 2) a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters – also known as operational qualification (OQ); and 3) and establishment of long term process stability – also known as performance qualification (PQ).
Many processes are controlled by computers.  While the computer software may be considered an integral part of the process, this guideline does not cover software validation.
While the theory of process validation is reasonably straightforward, the decision of the manufacturer to evaluate every process for potential validation may lead to uncertainty.  Some regulatory requirements state that every process that cannot be verified by subsequent monitoring or measurement be validated.  Guidance is provided for reaching decisions on whether to validate or not.
GHTF Study Group 3 - Quality Management Systems
Process Validation Guidance– January 2004
Page 5 1Purpose and scope
1.1Purpose    This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation.
1.2Scope    This document has general applicability to manufacturing (including servicing and installation) processes for medical devices.  Specific recommendations for verification of design output and design validation is included in the GHTF document covering design control.
2 Definitions
For this document, the following definitions apply.  Terms other than those defined herein may be found in the literature.
2.1Installation 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.
2.2Operational qualification (OQ): establishing by objective evidence process control limits and action l evels which result in product that meets all predetermined requirements.
2.3Performance qualification (PQ): establishing by objective evidence that the process, under anticipat
ed conditions, consistently produces a product which meets all predetermined requirements.
2.4Process validation:  establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.
2.5Process validation protocol:  a document stating how validation will be conduc ted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results.
2.6Verification:  confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.
3 Process validation within the quality management system
Process validation is part of the integrated requirements of a quality management system.  It is conducted in the context of a system including design and development control, quality assurance, process control, and corrective and preventive action.

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