As mentioned earlier, processes are "validated" and instruments are "qualified." Analytical instrument qualification (AIQ) provides documented evidence that the instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Qualification normally is grouped into four distinct phases, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). A definition and discussion of each of the qualification phases have been covered in previous "Validation Viewpoint" columns and elsewhere and really do not need to be repeated here (2,14). The AAPS publication also does an excellent job of capturing the definition and documentation of each of these phases as well, as an excellent discussion on software validation to which the reader is referred for more information (3). However, there are a couple of other significant areas that the AAPS group focused on that are worth noting; documentation and the categorization of instruments according to the level of qualification required.
Both static and dynamic documentation can result from an AIQ. Static documents are generated during the DQ, IQ, and OQ phases and should be kept in a separate qualification binder. Static documents can include such things as user manuals, site requirement documents, etc. Dynamic documents are generated during the OQ and PQ phases, when actual instrument testing takes place. These documents provide a running record for the instrument use and maintenance and should be kept in a system log book with the instrument, available for viewing as necessary by anyone interested (that is, the FDA). These documents also should be appropriately archived for future reference and protection.
Instruments were placed into three categories (A, B, and C), again based upon their complexity and proposed level of qualification.
The conformance of Group A instruments to user requirements is determined by visual observation; no independent qualification process is required. Examples of Group A instruments include spatulas, ovens, magnetic stirrers, microscopes, and vortex mixers.
The conformance of Group B instruments to user requirements is determined according to the instruments' SOP, and their failure usually is readily discernable. Examples of instruments that fall into this category are pH meters, balances, thermometers, refrigerator–freezers, and vacuum ovens.
Group C instruments are defined as highly method-specific, complex instruments with conformance determined by their application. Full qualification as outlined in the AAPS report is applied to instruments in this group. Examples include high performance liquid chromatography (HPLC) and gas chromatography (GC) instruments, spectrometers, mass spectrometers, and electron microscopes.
1-两个词语意思很相近。
2-一般而言,确认指得是局部和阶段性工作,而验证指得是全局和整体性工作。
3-DQ、IQ、OQ、PQ只是存在于设备、仪器和系统的验证中;在工艺验证、清洁验证和分析方法验证中,没有4个确认的概念。
Qualification: 合格, 鉴定, 判定, 合格证明[证书], 认证,资格证明书
verification 确认, 证实[明, 据]
validation 验证
2000版ISO9001标准:
3.8.4 验证 verification
通过提供客观证据(3.8.1)对规定要求(3.1.2)已得到满足的认定
注1:“已验证”一词用于表示相应的状态。
注2:认定可包括下述活动,如:
——变换方法进行计算;
——将新设计规范(3.7.3)与已证实的类似设计规范进行比较;
——进行试验(3.8.3)和演示;
——文件发布前的评审。
3.8.5 确认 validation
通过提供客观证据(3.8.1)对特定的预期用途或应用要求(3.1.2)已得到满足的认定
注1:“已确认”一词用于表示相应的状态。
注2:确认所使用的条件可以是实际的或是模拟的。
3.8.6 鉴定过程 qualification process
证实满足规定要求(3.1.2)的能力的过程(3.4.1)
注1:“已鉴定”一词用于表示相应的状态。
注2:鉴定可涉及到人员、产品(3.4.2)、过程或体系(3.2.1)。
示例:审核员鉴定过程、材料鉴定过程。
In Pharmaceutical Indusdry: (因为不同行业有不同的解释)
Verification and Validation (V&V) is the process of checking that a product, service, or system meets specifications
and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO
9000.
Verification is a quality process used to evaluate whether or not a product, service, or system complies with a
regulation, specification, or conditions imposed at the start of a development phase. Verification can be in
development, scale-up, or production. This is often an internal process.
Validation is the process of establishing documented evidence that provides a high degree of assurance that a product,
service, or system accomplishes its intended requirements. This often involves acceptance and suitability with external
customers.
http://www.fda.gov/CDER/GUIDANCE/pv.htm
Guideline on General Principles of Process Validation
Prospective validation - Validation conducted prior to the distribution of either a new product, or product made under a
revised manufacturing process, where the revisions may affect the product's characteristics.
Retrospective validation - Validation of a process for a product already in distribution based upon accumulated
production, testing and control data.
Validation & Calibration:
http://www.fda.com/forum/showtopic.php?tid/3496/
Validation: According to FDA glossary, it is "establishing documented evidence which provides a high degree of
assurance that a specific process will consistently produce a product meeting its predetermined specifications and
quality attributes".
Calibration: According to the National of Standards and Technology, Calibration is a measurement process that assigns
values to the property of an artifact or to the response of an instrument relative to reference standards or to a designated
measurement process. The purpose of calibration is to eliminate or reduce bias in the user's measurement system
relative to the reference base. The calibration procedure compares an "unknown" or test item(s) or instrument with
reference standards according to a specific algorithm.
Performance qualification is defined for processes, products and computer systems slightly differently. In your case,
probably the definitions in the FDA guidelines for process validation fit best, where it states that "Process performance
qualification - Establishing confidence that the process is effective and reproducible".
But in simpler words: Validation is the job to create the specifications and then to qualify your process (or whatever
you have) including the documentation thereof. Qualification is the process of the actual testing that you perform
during validation. And calibration is something you have to do routinely (often specified during validation as well) to
keep your instruments accurate with respect to a standard (and therefore validated).
validation
means documenting to prove suitable for intended purpose and it is generally accepted, following the V model, that this
means:
DQ URS, FRS, Design
IQ
OQ
PQ is confirming the URS
Maintain
Train
Change control.
Calibration is an activity that adjusts a device tool or what ever to correlate its reading to another device which could be
an international traceable standard.
Confirmation of the calibration can be covered in part of the validation work.
All validation work has to be scaled to the system / equipment in question, but should follow the general V model
principles. For small hand tools that require calibrating I have created a URS, done a calibration. A small hand tool is
not installed anywhere ergo no IQ. The fact that it has been calibrated means that it must function OK this can be the
OQ. The PQ confirms that the URS has ben met , so what ever was described as required has be satisfied this can be all
manner of odds and ends like power compatibility ease of use etc.
Qualification: DQ/IQ/OQ/PQ
Installation qualification - Establishing confidence that process equipment and ancillary systems are capable of
consistently operating within established limits and tolerances.
Process performance qualification - Establishing confidence that the process is effective and reproducible.
Product performance qualification - Establishing confidence through appropriate testing that the finished product
produced by a specified process meets all release requirements for functionality and safety.
[ Last edited by penn007 on 2007-11-12 at 14:24 ],
http://mediwire.skyscape.com/mai ... mp;ArticleID=187972
As mentioned earlier, processes are "validated" and instruments are "qualified." Analytical instrument qualification (AIQ) provides documented evidence that the instrument performs suitably for its intended purpose and that it is properly maintained and calibrated. Qualification normally is grouped into four distinct phases, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). A definition and discussion of each of the qualification phases have been covered in previous "Validation Viewpoint" columns and elsewhere and really do not need to be repeated here (2,14). The AAPS publication also does an excellent job of capturing the definition and documentation of each of these phases as well, as an excellent discussion on software validation to which the reader is referred for more information (3). However, there are a couple of other significant areas that the AAPS group focused on that are worth noting; documentation and the categorization of instruments according to the level of qualification required.
Both static and dynamic documentation can result from an AIQ. Static documents are generated during the DQ, IQ, and OQ phases and should be kept in a separate qualification binder. Static documents can include such things as user manuals, site requirement documents, etc. Dynamic documents are generated during the OQ and PQ phases, when actual instrument testing takes place. These documents provide a running record for the instrument use and maintenance and should be kept in a system log book with the instrument, available for viewing as necessary by anyone interested (that is, the FDA). These documents also should be appropriately archived for future reference and protection.
Instruments were placed into three categories (A, B, and C), again based upon their complexity and proposed level of qualification.
The conformance of Group A instruments to user requirements is determined by visual observation; no independent qualification process is required. Examples of Group A instruments include spatulas, ovens, magnetic stirrers, microscopes, and vortex mixers.
The conformance of Group B instruments to user requirements is determined according to the instruments' SOP, and their failure usually is readily discernable. Examples of instruments that fall into this category are pH meters, balances, thermometers, refrigerator–freezers, and vacuum ovens.
Group C instruments are defined as highly method-specific, complex instruments with conformance determined by their application. Full qualification as outlined in the AAPS report is applied to instruments in this group. Examples include high performance liquid chromatography (HPLC) and gas chromatography (GC) instruments, spectrometers, mass spectrometers, and electron microscopes.
[ Last edited by penn007 on 2007-11-12 at 14:23 ]
谢谢各位的帮助。个人比较理解2、3楼的解释,4楼的看不懂,嘿嘿.......(不懂英文)
很抱歉没有时间帮您翻译,您可以让懂英文的朋友帮您。
实际上我个人认为4楼和5楼才是较好地对问题进行了详细解释。
实际上把Qualification翻译为确认并不准确。
[ Last edited by penn007 on 2007-11-14 at 14:26 ]
PENN007,您太客气了!我会将您的回复交给我的同事翻译的,实际上,英文原文的翻译问题一直是我们的大问题,理解GMP的,英文不好,英语专业的又不懂GMP,经常有歧义,我两者都不是,见笑了.......