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					                                         Validation 관련 용어

약 어                                   관계법령                                                           발효일자
             의약품제조 및 품질관리기준
 의약                                                                                       [개정 2000·6·16]
             (제 40 조제 1 항제 7 호관련)
             의료용구제조 및 품질관리기준
 의용                                                                                       [신설 97·5·21]
             (제 22 조제 1 항제 4 호관련)
             PART 210--CURRENT GOOD MANUFACTURING                  [43 FR 45076, Sept. 29,
             PRACTICE IN MANUFACTURING, PROCESSING,                1978, as amended at 51 FR
             PACKING, OR HOLDING OF DRUGS; GENERAL--Table          7389, Mar. 3, 1986; 58
             of Contents Sec. 210.3 Definitions.                   FR 41353, Aug. 3, 1993]
                                                                   [London, 27 July 2000 /
             Note For Guidance on Medicinal gases : Pharmaceutical CPMP/QWP/1719/00
             documentation                                         Draft]

  EU         EU GMP Vol. 4                                           1998 edition
             Guidance for Industry Environmental Assessment of Human
 GFI                                                                 [July 1998]
             Drug and Biologics Applications
                                                                                          Federal Register / Vol. 62, No.
  c-5        Part V. department of Health and Human Services                              227 / Tuesday, November 25,
                                                                                          1997 / Notices
                                                                       on 27 October 1994 by the
V-AP         Text on Validation of Analytical Procedures
                                                                       ICH Steering Committee
             ICH Topic Q 6 B : test procedures and Acceptance Criteria Step. 3, Draft, 6 February
             for Biotechnological / biological Products                1998
             Good Manufacturing Practice Guide for Active On 19 July 2000 by the
             Pharmaceutical Ingredients                                ICH Steering Committee
             Validation of Aseptic Pharmaceutical Processes
 APP                                                                   1986
             Edited by Frederick J. Carleton & James P. Agalloco,
             Compliance Policy Guide, Parametric Release-Termanally
             Sterilized Drug Products
 P&V         의약품 제조와 Validation

                   의약품을 생산하기 위하여 행하여지는 모든 작업을 말하며, 포장 및 표시작업도
제조                                                                                                                    의약
                   이에 포함된다.
제조단위/              동일한 제조공정하에서 균질성을 갖도록 제조된 의약품의 일정한 분량을 말한
로트                 다.
                   제조공정에서 멸균을 한 의료용구로서 제품의 용기·포장등에 "멸균" 또는
                   "STERILE"이라는 문자, 멸균방법, 멸균연월일등 멸균품임을 표시한 제품을 말한                                                     의용
                   의료용구를 생산하기 위하여 행하여지는 작업(포장 및 표시작업을 포함한다)을
제조                                                                                                                    의용
제조단위/              동일한 제조공정하에서 균질성을 갖도록 제조된 의료용구의 일정한 분량의 단위
로트                 를 말한다.
                   Process Validation is the scientific study of a process :
                   1. To prove that the process is doing what it is supposed to do, i.e., that the process is under
                      control                                                                                         APP
                   2. To determine the process variables and acceptable limits for these variables, and to set up
                      appropriate in-process controls.
                     The performance of tests to determine if a component of a manufcturing process possesses
Qualification                                                                                                           APP
                     the attributes required to obtain a specified quality of a product
                     The performance of tests to determine the limits of capability for a component of a
Challenge            manufacturing process.       Limits of capability does not necessarily mean challenging until      APP
                     destruction, but limits of variation within which a defined level of quality can be assured
HVAC                 Heating, ventilation, and air conditioning                                                         APP
Prospective          Establishing documented evidence prior to process implementation that a system does what
validation           it purports to do based on a preplanned protocol
Concurrent           Establishing documented evidence that a process does what it purports to do based on
validation           information generated during actual implementation of the process.
Retrospective        Establishing documented evidence that a system does what it purports to do based on
validation           review and analysis of historical information.
Validation           A formal monitoring system by which qualified representatives of appropriate disciplines
change               review proposed or actual changes that might affect validated status and cause corrective          APP
control              action to be taken that will ensure that the system retains its validated state of control
Revalidation         Repetition of the validation process or a specific portion of it.                                  APP
                     Demonstrating that a measuring device produces results within specified limits of those
Calibration          produced by a reference standard device over an appropriate range of measurements.                 APP
                     This process results in corrections that may be applied if maximum accuracy is required.
Validation           A prospective or concurrent experimental plan that, when executed, is intended to produce
protocol             documented evidence that the system has been validated.
Sterilization        A treatment process from which probability of any microorganism survival is less than 10 -6,
process              or one in a million.
Nonsterilizatio      Any treatment process that purports to do something other than to sterilize.         It may be a
n process            method associated with, or even, integral to, one that sterilizes.
                     Those operating variables that can be assigned values that are used as control levels.             APP
Operating            All factors, including control parameters, that may potentially affect process state of control
variables            and/or fitness for use of the end product
State         of     A condition in which all operating variables that can affect performance remain within such
control              ranges that the system or process performs consistently and as intended.
Installation         Documented verification that all key aspects of the installation adhere to appropriate codes
qualification        and approved design and that manufacturer’s recommendations are suitably considered.
Operational          Documented verification that the system or subsystem performs as intendedthroughout all
qualification        anticipated operating ranges.
                     A throwaway, extendedmedium, dry-type filter in a rigid frame having minimum particle-
                     collection efficiency of 99.97% for 0.3㎛ thermally generated dioctyl phthalate (DOP)
HEPA filter                                                                                                             APP
                     particles, and a maximum clean-filter pressure drop of 1.0 in. water gate, when tested at
                     rated air-flow capacity.
HEPA        filter   The particle – removal efficiency of the individual filter unit as tested with thermally
efficiency           generated DOP aerosol and an aerosol penetrometer per Mil. STd. 282.
HEPA        filter
                     An in-place test of the bypass leakage of the HEPA filter system due to inadequate filters.
installation                                                                                                            APP
                     The leakage rate is determined with air-generated DOP aerosol and an aerosol photometer.
leak test
DOP           An aerosol generated by quenching (condensing) vapor that has been evaporated from
Theemally     liquid dioctyl phthalate by heat.    The aerosol mean particle diameter is between 0.2 and                APP
generated     0.4㎛ with a geometric standard deviation of 1.3.
              An aerosol generated by blowing air through liquid dioctyl phthalate at room temperature.
              When generated with a Laskin-type nozzle, the approximate light-scattering mean droplet
Air-Generated size distribution is as follows :
              99+% less than 3.0㎛                                                                                       APP
              50+% less than 0.7㎛
              10+% less than 0.4㎛
              An instrument for measuring air velocities based on the convective cooling effect of air
              flow on a heated wire.       Instruments of this type designed specifically for low air speeds            APP
              ranging from about 25 to 300 ft/min are suitable for velocity measurements.
              A device for measuring total, velocity, and static pressures of flowing fluid steams.     Pitot
Pitot tube    tubes for use with this standard shall conform to the proportions of Figure 7, AMCA                       APP
              Standard 210-67.
Air pressure An inclined manometer or magehelic gauge capable of measuring 0.01 to 2.0 in water gauge
gauge         static pressure.
                    Ventilation smoke tube pencil for generating visible smoke filament for air tracer studies.        APP
                 1An as-built facility is a clean room that is complete and ready for operation, with all
As-built facility                                                                                                      APP
                 services connected and functional, but without operating equipment or personnel
                 An at-rest facility is a clean room that is complete and has the operating equipment
At rest facility                                                                                                       APP
                 installed, but without personnel
Operational      An operational facility is a clean room in normal operation with all services functional and
facility         with operating equipment and personnel present.
Laminar air flow A clean room in which the absolute filtered air makes a single pass through the enclosure in
clean room       a layered, parallel-flow patone wall (horizontal flow) and air velocities are uniform.
                 These rooms have certain common equipment : central heating, ventilation, and air
                 conditioning plant, and a duct network or air supply ; return air ducts and a self-contained
Air     handling air handling system used for air recirculation through HEPA filters exclusively (usually at
systems          the laminar flow units).      A central air handling system is generally defined as the primary
                 air handling system and the self-contained system or the laminar-flow units are the
                 secondary system.
                 Acceptance criteria means the product specifications and acceptance/rejection criteria, such
Acceptance       as acceptable quality level and unacceptable quality level, with an associated sampling plan,
criteria         that are necessary for making a decision to accept or reject a lot or batch (or any other
                 convenient subgroups of manufactured units).
                 Batch means a specific quantity of a drug or other material that is intended to have uniform
Batch            character and quality, within specified limits, and is produced according to a single                 C210
                 manufacturing order during the same cycle of manufacture.
                 Fiber means any particulate contaminant with a length at least three times greater than its
Fiber                                                                                                                  C210
                 Lot means a batch, or a specific identified portion of a batch, having uniform character and
                 quality within specified limits; or, in the case of a drug product produced by continuous
Lot                                                                                                                    C210
                 process, it is a specific identified amount produced in a unit of time or quantity in a manner
                 that assures its having uniform character and quality within specified limits.
                 Processing, packing, or holding of a drug product includes packaging and labeling
Manufacture                                                                                                            C210
                 operations, testing, and quality control of drug products.
Quality control Quality control unit means any person or organizational element designated by the firm to
unit             be responsible for the duties relating to quality control.
                 Representative sample means a sample that consists of a number of units that are drawn
                 based on rational criteria such as random sampling and intended to assure that the sample             C210
                 accurately portrays the material being sampled.
                 (i)     The concentration of the drug substance (for example, weight/weight,
                       weight/volume, or unit dose/volume basis), and/or
Strength         (ii)    The potency, that is, the therapeutic activity of the drug product as indicated by            C210
                       appropriate laboratory tests or by adequately developed and controlled clinical data
                       (expressed, for example, in terms of units by reference to a standard).
Acceptance       Numerical limits, ranges, or other suitable measures for acceptance of the results of
criteria         analytical procedures.
                 A molecule resulting from a chemical change in the drug molecule brought about over time
                 and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient         c-5
                 and/or the immediate container / closure system.       Also called decomposition product.
                 Any component of the new drug substance that is not the chemical entity component of the
Impurity         drug product that is not the chemical entity defined as the drug substance or an excipient in         c-5
                 the drug product.
                 A pharmaceutical product type, for example, tablet, capsule, solution, cream, that has not
New         drug
                 previously been registered in a region or Member State, and which contains a drug                     c-5
                 ingredient generally, but not necessarily, in association with excipients.
                 The designated therapeutic moiety, that has not previously been registered in a region or
New         drug
                 Member State (also referred to as a new molecular entity or new chemical entity).           It may    c-5
                 be a complex, simple ester, or salt of a previously approved drug substance.
                 the suitability of either a drug substance or drug product for its intended use.         This term
Quality                                                                                                                c-5
                 includes such attributes as the identity, strength, and purity of the article.
                 A test that is considered to be applicable to particular new drug substances or particular new
Specific test                                                                                                          c-5
                 drug products depending on their specific properties and/or intended use.
                 A list of tests, references to analytical procedures, and appropriate acceptance criteria that
Specification    are numerical limits, ranges, or other criteria for the tests described.     It establishes the set   c-5
                 of criteria to which a drug substance or drug product should conform to be considered
                   acceptable for its intended use. “Conformance to specifications” means that the drug
                   substance and/or drug product, when tested according to the listed analytical procedures,
                   will meet the listed acceptance criteria.     Specifications are binding quality standards that
                   are agreed to between the appropriate governmental regulatory agency and the applicant.
Parametric         완제품의 무균시험대신에 validate 된 멸균공정 사이클을 효과적으로 관리하고
release            모니터링하여 기록한 것을 근거로 무균판정을 내리는 절차.
Parametric         제조공정중에 얻은 정보와 parametric release에 관한 특정 GMP요건에 맞는다는
release            것에 근거하여 원하는 품질을 확보하였음을 보증하는 출하승인 제도.
                  A defined quantity of starting material, packaging material or product processed in one
                     process or series of processes so that it could be expected to be homogeneous.

                   Note : To complete certain stages of manufacture, it may be necessary to divide a batch into
                    a number of sub batches, which are later brought together to form a final homogeneous
                    batch.     In the case of continuous manufacture, the batch must correspond to a defined
                    fraction of the production, characterised by its intended homogeneity.
Batch (or Lot)                                                                                                       EU
                      For control of the finished product, the following definition has been given in Directive
                      75/318/EEC : ‘For the control of the finished product, a batch of a proprietary medicinal
                      product comprises all the units of a pharmaceutical form which are made from the same
                      initial mass of material and have undergone a single series of manufacturing operations
                      or a single sterilisation operation or, in the case of a continuous production process, all
                      the units manufactured in a given period of time’.
                   The set of operations which establish, under specified conditions, the relationship between
Calibration        values indicated by a measuring instrument or measuring system, or values represented by a        EU
                   material measure, and the corresponding known values of a reference standard.
                   An area with defined environmental control of particulate and microbial contamination,
                   constructed and used in such a way as to reduce the introduction, generation and retention
                   of contaminants within the area.
Clean area                                                                                                           EU
                   Note : The different degrees of environmental control are defined in the Supplementary
                         Guidelines for the Manufacture of sterile medicinal products.
Computerised       A system including the input of data, electronic processing and the output of information to
system                   be used either for reporting or automatic control.
                   The action of confining a biological agent or other entity within a defined space.

                    Primary containment : A system of containment which prevents the escape of a biological
                       agent into the immediate working environment.            It involves the use of closed
                       containers or safety biological cabinets along with secure operating procedures.
Containment                                                                                                         EU
                    Secondary containment : A system of containment which prevents the escape of a biological
                       agent into the external environment or into other working areas. It involves the use of
                       rooms with specially designed air handling, the existence of airlocks and/or sterilisers for
                       the exit of materials and secure operating procedures. In many cases it may add to the
                       effectiveness of primary containment.
                   An area constructed and operated in such a manner that some attempt is made to control the
                         introduction of potential contamination (an air supply approximating to grade D may
                         be appropriate), and the consequences of accidental release of living organisms.
Controlled area          The level of control exercised should reflect the nature of the organism employed in EU
                         the process. At a minimum, the area should be maintained at a pressure negative to
                         the immediate external environment and allow for the efficient removal of small
                         quantities of airborne contaminants.
                   Contamination of a material or of a product with another material or product.                     EU
                   Checks performed during production in order to monitor and if necessary to adjust the
                   process to ensure that the product conforms its specification.        The control of the          EU
                   environment or equipment may also be regarded as a part of in-process control
                   Equipment or apparatus designed to enable one or more gas containers to be filled
Manifold                                                                                                             EU
                   simultaneously from the same source.
                   All operations of purchase of materials and products, Production, Quality Control, release,
Manufacture                                                                                                          EU
                   storage, distribution of medicinal products and the related control.
                   Holder of a Manufacturing Authorization as described in Article 16 of Directive
Manufacturer                                                                                                         EU
                  All operations, including filling and labeling, which a bulk product has to undergo in order
                  to become a finished product.
Packaging                                                                                                           EU
                  Note : Sterile filling would not normally be regarded as part of packaging, the bulk product
                         being the filled, but not finally packaged, primary containers.
                  All operations involved in the preparation of a medicinal product, from receipt of materials,
Production                                                                                                          EU
                  through processing and packaging, to its completion as a finished product.
                  Action of proving that any equipment works correctly and actually leads to the expected
Qualification     results.      The word validation is sometimes widened to incorporate the concept of              EU
                  Quality Assurance is a wide ranging concept which covers all matters which individually or
                  collectively influence the quality of a product.         It is the sum total of the organized
Quality Control                                                                                                     EU
                  arrangements made with the object of ensuring that medicinal products are of the quality
                  required for their intended use.
                  Records provide a history of each batch of product, including its distribution, and also of all
Record                                                                                                              EU
                  other relevant circumstances pertinent to the quality of the final product.
                  The introduction of all or part of previous batches of the required quality into another batch
Recovery                                                                                                            EU
                  at a defined stage of manufacture.
                  The reworking of all or part of a batch of product of an unacceptable quality from a
Reprocessing      defined stage of production so that its quality may be rendered acceptable by one or more         EU
                  additional operations.
                  There should be appropriately authorised and dated specifications for starting and packaging
Specification     materials, and finished products ; where appropriate, they should be also available for           EU
                  intermediate or bulk products.
                  Sterility is the absence of living organism. The conditions of the sterility test are given in
Sterility                                                                                                           EU
                  the European Pharmacopoeia.
                  Is used in the sense of a regulated pattern of interacting activities and techniques which are
System                                                                                                              EU
                  united to form an organised whole.
                  Action of proving, in accordance with the principles of Good Manufacturing Practice, that
Validation        any procedure, process, equipment, material, activity or system actually leads to the             EU
                  expected results (see also qualification)
                  A submission of information to the FDA by a person who intends it to be referenced during
Master file       the review of an application.        See 21 CFR 314.420 for specific information on drug          GFI
                  master files.
inhibitory        The lowest concentration of a chemical that inhibits the visible growth of the test
concentration     organisms.
                  A specific quantity of material produced in a process or series of processes so that it is
                  expected to be homogeneous within specified limits.            In the case of continuous
Batch (of Lot)    production, a batch may correspond to a defined fraction of the production.     The batch         i-Ai
                  size may be defined either by a fixed quantity or the amount produced in a fixed time
                  The level and type (e.g. objectionable or not) of micro-organisms which may be present in
                  raw materials, API starting materials, intermediates or APIs.     Bioburden should not be
Bioburden                                                                                                           i-Ai
                  considered contamination unless the levels have been exceeded or defined objectionable
                  organisms have been detected.
                  The demonstration that a particular instrument or device produces results within specified
Calibration       limits by comparison with those produced by a reference or traceable standard over an             i-Ai
                  appropriate range of measurements.
Computer          A group of hardware components and associated software, designed and assembled to
system            perform a specific function or group of functions.
                  A process or operation integrated with a computer system.                                         i-Ai
                  The undesired introduction of impurities of a chemical or microbiological nature, or of
Contamination     foreign matter, into or onto a raw material, intermediate, or API during production,              i-Ai
                  sampling, packaging or repackaging, storage or transport.
                  A process step, process condition, test requirement, or other relevant parameter or item that
Critical          must be controlled within predetermined criteria to ensure that the API meets its                 i-Ai
                  Contamination of a material or product with another material or product.                          i-Ai
Impurity              Any component present in the intermediate or API that is not the desired entity.                     i-Ai
Control         (or   Checks performed during production in order to monitor and, if necessary, to adjust the
Process               process and/or to ensure that the intermediate or API conforms to its specifications.
                      A specific quantity of material produced in a process or series of processes so that it is
                      expected to be homogeneous within specified limits.             In the case of continuous
Lot                   production, a batch may correspond to a defined fraction of the production.        The batch         i-Ai
                      size may be defined either by a fixed quantity or the amount produced in a fixed time
                      All operations of receipt of materials, production, packaging, repackaging, labelling,
Manufacture           relabelling, quality control, release, storage, and distribution of APIs and the related             i-Ai
                      Checks performed during production in order to monitor and, if necessary, to adjust the
Process Control                                                                                                            i-Ai
                      process and/or to ensure that the intermediate or API conforms to its specifications.
                      All operations involved in the preparation of an API, from receipt of materials, through
Production                                                                                                                 i-Ai
                      processing and packaging, to its completion as a finished API.
                      Action of proving and documenting that equipment or ancillary systems are properly
                      installed, work correctly, and actually lead to the expected results.    Qualification is part
Qualification                                                                                                              i-Ai
                      of validation, but the individual qualification steps alone do not constitute process
                      The sum total of the organised arrangements made with the object of ensuring that all APIs
Assurance                                                                                                                  i-Ai
                      are of the quality required for their intended use and that quality systems are maintained.
Quality Control
                      Checking or testing that specifications are met.                                                     i-Ai
                      An organizational unit independent of production which fulfills both Quality Assurance and
Quality Unit(s)       Quality Control responsibilities.    This may be in the form of separate QA and QC units or i-Ai
                      a single individual (or group), depending upon the size and structure of the organization.
                      A substance that has been shown by an extensive set of analytical tests to be authentic
                      material that should be of high purity.    This standard may be obtained from an officially
Standard,                                                                                                         i-Ai
                      recognised source or may be prepared by independent synthesis or by further purification of
                      existing production material.
                      A substance of established quality and purity, as shown by comparison to a primary
Standard,                                                                                                                  i-Ai
                      reference standard, used as a reference standard for routine laboratory analysis.
                      Introducing an intermediate or API, including one that does not conform to standards or
                      specifications, back into the process and repeating a crystallization step or other appropriate
                      chemical or physical manipulation steps (e.g., distillation, filtration, chromatography,
Reprocessing                                                                                                               i-Ai
                      milling) that are part of the established manufacturing process.              Continuation of a
                      chemical reaction after an in-process control test shows the reaction to be incomplete is
                      considered to be part of the normal process, and not reprocessing.
                      Subjecting an intermediate or API that does not conform to standards or specifications to
Reworking             one or more processing steps that are different from the established manufacturing process           i-Ai
                      so that its quality may be made acceptable (e.g., recrystallizing with a different solvent).
                      A list of tests, references to analytical procedures, and appropriate acceptance criteria that
                      are numerical limits, ranges, or other criteria for the test described.     It establishes the set
Specification         of criteria to which a material should conform to be considered acceptable for its intended          i-Ai
                      use.      “Conformance to specification” means that the material, when tested according to
                      the listed analytical procedures, will meet the listed acceptance criteria.
                      A documented program that provides a high degree of assurance that a specific process,
Validation            method, or system will consistently produce a result meeting predetermined acceptance                i-Ai
                      A written plan stating how validation will be conducted and defining acceptance criteria.
Validation            For example, the protocol for a manufacturing process identifies processing equipment,
Protocol              critical process parameters/operating ranges, product characteristics, sampling, test data to
                      be collected, number of validation runs, and acceptable test results.
                      최종제품의 시험결과에 의하지 않고 validation결과를 근거로 하여 멸균공정의 주
Parametric                                                                                                                 JP
                      요 파라미터(온도, 습도, 압력, 시간, 등) 및 제조기록등을 조사하여 출하여부를
release                                                                                                                    XIII
                      판단하는 일.
Dedicated             Specific for a gas for medicinal use                                                                 M-gs
Packaging             All the operations, including filling and labelling, that must be undergone by a bulk product        M-gs
                     to become a finished product.
                     Medical device for pressure reduction.             M-gs
공정발리데이션              어떤 공정이 미리 설정한 규격과 품질특성 (예를들면, 역가, 순도, 안정성, 안전
(Process             성 등) 에 적합한 제품을 일관되게 생산할 수 있다는 것을 확실하게 보증할 수 P&V
Validation)          있고 그 결과를 문서화하는 것
                     의약품의 제조에 있어 공업화연구의 결과나 유사품목에 대한 과거의 제조실적
예측적발리데이션             등을 토대로 하여 품질에 영향을 미치는 변동요인 (원료 및 자재의 물성, 공정
(Prospective         조건 등. 이하 “변동요인”이라 함) 을 특정하여 그 변동요인에 대한 허용조건이 P&V
Validation)          품질기준에 적합한 의약품을 항상 일정하게 제조하는 데 타당하다는 것을 검증
                     하는 것이다.
(Concurrent /        실제로 의약품을 생산하면서 실시하는 것으로 변동요인이 허용조건 내에 있다는
Ongoing              것을 공정관리 등에 의해서 확인하는 것을 말한다.
재발리데이션               공정의 변경 또는 제조작업환경의 변화가 있는 경우에 공정의 성질과 제품의 품
(Revalidation)       질에 나쁜 영향을 미치지 않는다는 것을 확인하기 위하여 실시하는 것이다.
변경시 재발리
데이션                  의약품의 품질에 영향을 미치는 원료, 자재, 제조방법, 공정관리방법, 설비·기기
Revalidation         및 지원 시스템 (작업환경, 공조설비, 제조용수 등) 에 변경이 있을 때 실시한다.
after Change
정기적 재발리
데이션                  의도적인 변경이 없는 경우에도 스케줄에 따라서 재발리데이션을 할 필요가 있
(Periodic            는데 작업을 하면서 실시하는 점에서는 동시적 발리데이션이라고 할 수 있다.
회고적 발리데              예측적 발리데이션을 하지만 회고적 발리데이션은 기업에 새롭게 발리데이션이
이션                   도입되었을 때 또는 정기적 재발리데이션의 실시시기 및 실시항목을 정하기 위
Retrospective        하여 기존 제품의 제조기록 및 시험데이터를 통꼐학적 방법으로 해석하는 것이
Validation           다.
                     의약품의 분석에 사용하는 시험법이 그 의도에 부합된다는 것, 즉 시험법의 오
시험법 발리데
                     차로 인한 판정오류의 확률이 허용되는 정도라는 것을 과학적으로 입증하는 것 P&V
                     그 방법으로 얻어진 시험결과(실측치)와 진실의 수치 (참값)와 일치하는 정도를
(Accuracy/Tru                                                           P&V
                     나타내는 것이다.
정도                   시험법의 정도는 균일한 재료로부터 다수의 검체를 시험했을 때 시험결과 간에
(Precision)          일치(재현성) 하는 정도를 나타내는 것을 말한다.
                     공존이 예측되는 불순물, 분해물, 배합성분 등의 존재 하에서 이 성분들의 영향
                     을 받지 않고 분석 대상물을 정확하게 특이적으로 측정할 수 있는 능력을 말한         P&V
감도                   농도의 미소변화를 기록할 수 있는 시험법의 성능을 말하는 것으로서 Calibration
(Sensitivity)        curve의 경사에 해당한다. 검출한계나 정량한꼐와는 다르다.
                     정상적인 시험조건 (시험실, 시험자, 시험기기, 시약 로트, 분석 소요시간, 분석
견뢰성                  온도, 분석날짜 등) 의 변화 하에서 동일한 시료를 분석하여 얻어지는 시험결과
(Reggedness)         의 재현성의 정도를 말한다.     이것은 시험법이 시험변수 및 환경 변수의 영향
                     을 받는 정도를 말한다.
                     분석조건의 약간의 변화(반응액의 pH, 시약의 양 등의 차) 에 의해서 영향을 받
                     는 정도를 말하며 그 분석법에 대한 신뢰성의 지표가 된다.     완건성과 견뢰성      P&V
                     을 같은 의미로 쓰기도 한다.
직선성                  시료중에 함유되어 있는 분석대상물의 양 또는 농도에 대하여 직선적인 비례관
(Linearity)          계를 나타내는 능력을 말한다.
범위                   적절한 진도와 정도 또는 직선성을 가지고 측정된다는 것이 증명된 분석대상물
(Range)              의 최고농도와 최저농도 또는 양의 사이(간격)를 말한다.
                     시료에 포함되는 분석대상물의 검출이 가능한 최소량 또는 최저 농도를 말하며
(Limit          of                                                      P&V
                     검출한계에서는 정량을 할 수 없는 경우도 있다.
정량한계               시료중에 포함되어 있는 분석대상물의 정량이 가능한 최소량 Ehsms 최저농도를
(Limit        of                                                          P&V
설치적격성 황
인                  설비·기기가 설계규격대로 제작되었는지, 또 소기의 기능을 발휘할 수 있도록
(Installation      적절히 설치되었는지를 시방서와 실물을 대조하여 현장에서 검증하고 기록하는               P&V
Qualification,     것이다.
가동성능 적격
성 확인               설비가 설계규격 범위내의 조건에서 적절하게 운전되는지를 검증하는 것이다.
(Operational                                                P&V
                   IQ는 정지상태에서의 검증이지만 OQ는 가동상태에서의 실제 검증이다.
제조성능 적격
성           확인     OQ단계가 끝난 설비를 사용하여 챨렌지시험 등의 방법으로 제조방법, 제조설비
(Performance       등이 공정조건의 범위 내에서 실제로 규정된 품질의 제품을 일관되게 생산될 수             P&V
Qualification,     있는지를 검증함으로서 종합적으로 제조공정의 능력을 평가하는 것이다.
                   표준기를 사용하여 계측기기가 나타내는 값과 참값을 비교하여 오차가 허용범위
                   내에 있음을 확인하고 허용오차 범위를 벗어났을 때는 보정하거나 수리하여 기 P&V
                   준범위 내에 들도록 조정하는 것을 말한다.
                   분석법의 정확성은 참값으로 인증 또는 합의된 갑과 실제 측정치 사이에 일치되
정확성                는 정도를 말한다.      실제에 있어서는 참값(True value) 과 측정치 (Measured
(Accuracy,                                                                 P&V
                   value) 의 총 평균과의 차로 나타낸다. 정밀성은 시험법의 정확도를 측정하는
                   시험법의 정밀성이란 균일한 검체로부터 다수의 시료를 취하여 반복하여 시험을
                   실시하는 경우에 각 시험결과 사이의 일치하는 정도를 일컫는다.          정밀성은 통 P&V
                   상의 조작 조건에서 시험법의 재현성의 정도를 아는 척도이다.
                   단시간에 동일 조건하에서 측정                                       P&V
성                  동일시설 내에서 시험일자, 시험실시자, 기구, 기기 등을 변경시켜 측정하는 경
(Intermediate      우의 정밀성
성                  다른 시설에서 분석일자, 분석자, 분석기기, 시약의 Lot 등을 다른 조건으로, 균
(Reproducibilit    일한 검체로부터 채취한 복수의 시료를 반복해서 분석할 때의 정밀도이다.
                   시료중에 존재하는 분석대상물의 검출가능한 최저량을 말한다.         검출한계는 한
검출한계               계시험의 특정치로서 반드시 정량할 수 있어야 할 필요는 없다.        한계시험에서
(Detection         는 검체 농도가 일정수준이상에 있는지 이하에 있는지를 입증하는 것을 목적을              P&V
Limit)             하고 있다.  일반적으로 검출한계는 시료중의 검체농도 (%, ppm, ppb등) 로 표
                   적절한 정밀성과 정확성을 가지고 정량되는 시료 중에 존재하는 분석대상물의
                   최저의 양을 말한다.   정량한계는 원료약품중의 불순물 또는 최종완제품 중의
정량한계               분해물과 같이 시료중의 함량이 얕은 수준에 있는 화합물로 인한 정량분석의 특
(Quantitation                                                             P&V
                   성치이다.  이것은 일정한 실험조건 하에서 측정할 수 있는 분석대상물의 최저
                   농도를 가리킨다.   정량한계는 시료 중의 검체농도 (%, ppm, ppb등) 로서 표시
                공존이 예측되는 불순물, 분해물, 배합성분 드으이 존재하에서 분석대상물을 정
                확히 측정할 수 있는 능력을 말한다.                             즉, 시험법의 특이성은 시료 matrix중에
                존재할 것으로 예상되는 성분의 영향을 받지 않고 분석대상물을 정확하고도 특
                이적으로 측정하는 능력을 말한다.                           특이성은 불순물, 분해물, 관련화합물을 함
                유하는 시료의 시험으로부터 얻어지는 시험결과의 편차 (bias) 의 정도 또 첨가
                물질이 포함되지 않는 시료의 시험결과와 비교하는 경우에는 시험결과의 편차의
                정도로서 나타낸다.                                                                                      P&V
                각 시험이나 분석방법에 대하여 위의 정의는 다음과 같은 의미를 갖는다.
                확인시험 : 분석대상무르이 존재를 확실히 한다.
                순도시험 : 시행되는 모든 분석조작으로 분석대상물의 불순물 (유연물질, 중금
                속, 잔류용매) 의 함량을 정확히 알 수 있다.
                정량 : 정확한 결과를 알려주는 데 이것은 검체 중 분석대상물의 함량 또는 역
                가를 알 수 있다.
                분석법의 직선성이란 일정한 범위 내에서 시료중의 분석 대상물의 농도 (양) 와
                직접적으로 또는 잘 정의된 수학적 전환에 의해서 직선관계에 있는 측정치를 부                                                      P&V
                여하는 능력을 말한다.
                분석방법의 범위란 적절한 정밀성, 정확성, 직선성을 부여하는 대상물의 하한 및
                상한의 양(농도) 사이에 있는 영역을 말한다.                                 범위는 분석대상물에 의해 얻어                      P&V
                지는 시험결과와 같은 단위 (%, ppm등) 로 표시된다.
                건실성의 평가는 분석법의 개발단계에서 고려되어야 하고 연구중에 있는 분석과
                정의 type 에 의존되고 있다.                   강건성은 분석법 특정치의 고의적인 변경과 관련
                하여 분석의 신뢰성을 보여주어야 한다.
건실성             분석조건하에서 측정이 변동을 받기 쉬우면 그 분석조건은 적절하게 조절되어야
(Robustness)    하거나 조작 설명서에 주의사항이 첨가되어야 한다;.                                        일련의 건실성의 평가는
                분석조작의 유효성이 사용할 때마다 유지되고 있음을 보장하기 위하여 일련의
                System Suitability Characteristics (예로서 resolution test)가 확립되어야 한다는 것이
                분석법의 견뢰성이란 정상적인 시험조건 범위 내의 여러 조건 아래에서 동일 시
                료를 분석할 때에 얻어진 분석결과의 재현성 (Reproducibility)의 정도를 의미한
                다.      여러가지 조건이란 실험실이 다르고 분석의 일시가 다르고 분석시의 온도
                가 다른 것 등을 가리킨다.                     견뢰성이란 통상 조작과 호나경상읩 usehd이 분석                                P&V
                결과에 주는 영향의 정도가 작은 것을 나타낸다.                                     견뢰성은 실험실과 실험자가
                변함에 따라 변동되는 것을 고려하여 정상적인 실험 조건 하에서의 재현성의 척
시스템적합성          시스템적합성 시험은 많은 분석법의 중요 부분 가운데 하나이다.                                                이 시험은
시험              장치, 전자, 분석조작 및 분석해야 할 검체가 종합적으로 평가될 수 있는 주요한
(System         system을 고성한다는 개념에 기초를 두고 있다.                                  특정실험조작을 위해 확립되                    P&V
Suitability     어야 할 system적합성 시험의 특성치는 Validation해야 할 조작의 type 에 의존하
Test)           고 있다.
                Numerical limits, ranges, or other suitable measures for acceptance which the drug
                substance or drug product or materials at other stages of their manufacture should meet to      Q6B
                conform with the specification of the results of analytical procedures
                An action limit is an internal (in-house) value used to assess the consistency of the process
Action Limits                                                                                                   Q6B
                at less critical steps.  These limits are the responsibility of the manufacturer
                Any adventitiously introduced material (e.g., chemical, biochemical, or microbial species)
Contaminants                                                                                                    Q6B
                in the drug substance / drug product not intended to be part of the manufacturing process.
                An ingredient added intentionally to the drug product or drug substance which should not
Excipient                                                                                                       Q6B
                have pharmacological properties in the used quantity.
                Any component present in the drug substance or drug product which is not the desired
Impurity        product, a product-related substance, or excipient (including added buffer components). It      Q6B
                may be either process or product-related.
In-House        A primary reference material is an appropriately characterized material prepared by the
Primary         manufacturer from a representative lot(s) for the purpose of biological assay and
Reference       physicochemical testing of subsequent lots, and against which in-house working reference
Material        material is calibrated.
In-House        the in-house working reference material is a material prepared similarly to the primary
Working         reference material and is established solely to assess and control subsequent lots for the
Reference           individual attribute in question.       It is always calibrated against the in-house primary
Material            reference material.
                    Impurities that are derived from the manufacturing process.         They may be derived from
                    cell substrates, culture (e.g., inducers, antibiotics, or media components), or from              Q6B
                    downstream processing (e.g., processing reagents or column leachables).
                    Product-related impurities are molecular variants of the desired product arising from
Product         –
                    processing or during storage (e.g., certain degradation products), which do not have
Related                                                                                                               Q6B
                    properties comparable to these of the desired product with respect to activity, efficacy, and
                    Product – related substances are molecular variants of the desired product which are active
Product         –
                    and have no deleterious effect on the safety and efficacy of the drug product.            These
related                                                                                                               Q6B
                    variants possess properties comparable to the desired product and are not considered
                    A specification is a legally binding list of tests, references to analytical procedures, and
                    appropriate acceptance criteria with numerical limits, ranges, or other criteria for the tests
Specification       described, which establishes the set of criteria to which a drug substance or drug product or     Q6B
                    materials at other stages of their manufacture should conform to be considered acceptable
                    for its intended use.
                    The accuracy of an analytical procedure expresses the closeness of agreement between the
Accuracy            value which is accepted either as a conventional true value or an accepted reference value        V-AP
                    and the value found. This is sometimes termed trueness.
                    The analytical procedure refers to the way of performing the analysis.       It should describe
Analytical          in detail the steps necessary to perform each analytical test.      This may include but is not
procedure           limited to : the sample, the reference standard and the reagents preparations, use of the
                    apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.
                    The detection limit of an individual analytical procedure is the lowest amount of analyte in
Detection Limit                                                                                                       V-AP
                    a sample which can be detected but not necessarily quantitated as an exact value.
                    the linearity of an analytical procedure is its ability (within a given range) to obtain test
Linearity           results which are directly proportional to the concentration (amount) of analyte in the           V-AP
                    The precision of an analytical procedure expresses the closeness of agreement (degree of
                    scatter) between a series of measurements obtained from multiple sampling of the same
                    homogeneous sample under the prescribed conditions.            Precision may be considered at
                    three levels : repeatability, intermediate precision and reproducibility.
Precision           Precision should be investigated using homogeneous, authentic samples.           However, if it   V-AP
                    is not possible to obtain a homogeneous sample it may be investigated using artificially
                    prepared samples or a sample solution.
                    The precision of an analytical procedure is usually expressed as the variance, standard
                    deviation or coefficient of variation of a series of measurements.
                    The quantitation limit of an individual analytical procedure is the lowest amount of analyte
                    in a sample which can be quantitatively determined with suitable precision and accuracy.
                    The quantitation limit is a parameter of quantitative assays for low levels of compounds in       V-AP
                    sample matrices, and is used particularly for the determination of impurities and/or
                    degradation products.
                    The range of an analytical procedure is the interval between the upper and lower
                    concentration (amounts) of analyte in the sample (including these concentrations) for which
Range                                                                                                                 V-AP
                    it has been demonstrated that the analytical procedure has a suitable level of precision,
                    accuracy and linearity.
                    Repeatability expresses the precision under the same operating conditions over a short
Repeatability                                                                                                         V-AP
                    interval of time.     Repeatability is also termed intra-assay precision.
                    Reproducibility expresses the precision between laboratories (collaborative studies, usually
Reproducibility                                                                                                       V-AP
                    applied to standardization of methodology).
                    The robustness of an analytical procedure is a measure of its capacity to remain unaffected
Robustness          by small, but deliberate variations in method parameters and provides an indication of its        V-AP
                    reliability during normal usage.
                    Specificity is the ability to assess unequivocally the analyte in the presence of components
                    which may be expected to be present.               Typically these might include impurities,
                    degradants, matrix, etc.
Specificity         Lack of specificity of an individual analytical procedure may be compensated by other             V-AP
                    supporting analytical procedure(s).

                    This definition has the following implications :Identification : to ensure the identity of an

Purity Tests : to ensure that all the analytical procedures performed allow an accurate
   statement of the content of impurities of an analyte, i.e. related substances test, heavy
   metals, residual solvents content, etc.

Assay (content or potency) : to provide an exact result which allows an accurate statement
   on the content or potency of the analyte in a sample.

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