Microsoft Word - annex 4-2 Korean good manufacturing practices for investigational products in Kor Eng

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1 Enforcement Rule for Medicinal Product Safety Annex 4-2 "Good Manufacturing Practice for Investigational Medicinal Products" KOREAN GOOD MANUFACTURING PRACTICE REGULATION FOR INVESTIGATIONAL MEDICINAL PRODUCTS August 21, 2014 Note: This English version translated by is not officially approved or endorsed by the Korean regulatory authority, the Ministry of Food and Drug Safety. 1

2 [Annex 4-2] GOOD MANUFACTURING PRACTICE FOR INVESTIGATIONAL MEDICINAL PRODUCTS (Article 24, Paragraph 1, Sub-paragraph 2 and Article 30, Paragraph 1, Sub-paragraph 9 of the Enforcement Rule for Medicinal Product Safety) 1. 개요 1. Introduction 1.1 목적 1.1 Purpose 이기준은개발단계에있는임상시험용의약품의제조과정에서 The purpose of this Regulation is to specify good manufacturing 필요한품질, 안전성및유효성을확보하여임상시험에참여하는 practice requirements, in order to assure quality, safety and 시험대상자를보호하고, 시험결과의신뢰성을보증할수있도록 efficacy of investigational medicinal products under development 준수하여야할사항을규정하는것을목적으로한다. stage, to protect subjects participating in clinical trials and to assure the reliability of clinical data. 2. 용어의정의 2. Definitions 이기준에서사용하는용어의뜻은다음과같다. Terms used in this Regulation have the following meanings. 가. " 의뢰서 (Order)" 란의뢰자가임상시험준비또는진행을 A. "Order" means an instructional document provided to an 위하여 임상시험용의약품의 일정단위를 제조 (Process), investigational medicinal product manufacturer by a 포장 (Package), 운송 (Ship) 토록임상시험용의약품제조업자등에게의뢰하는문서를말한다. sponsor to process, package and ship a certain number of units of investigational medicinal products for use in clinical trials. 나. " 임상시험용의약품 기준 자료집 (Product Specification B. "Product Specification File" means a reference file File)" 이란임상시험용의약품의제조, 포장, 품질관리시험, containing or a list referring to files containing, all the 출하승인 및 운송에 대하여 구체적인 서면 지시서를 information necessary to draft the detailed written 작성하는데 필요한 정보를 포함한 자료집 또는 해당 instructions on processing, packaging, quality control 2

3 정보를포함하는문서들에대한목록을말한다. 다. " 무작위배정코드 (Randomization Code)" 란무작위배정과정에서시험대상자를각치료군에배정하기위하여통계학적으로적절하게생성된식별기호목록을말한다. testing, lot release and shipping of an investigational medicinal product. C. "Randomization Code" means a list of identification codes created in a statistically appropriate manner, in which treatment assigned to each subject from the randomization process is identified. 3. 기본원칙 3. General Principles 가. 임상시험용의약품을제조하려는자는별표 1의의약품 A. A person who intends to manufacture an investigational 제조 및 품질관리기준을 준수하여야 하며, medicinal product should comply with "GMP for Medicinal 생물학적제제등인경우별표 3, 방사성의약품인경우별표 3의2, 의료용고압가스인경우별표 3의3을준수하여야 Products" in Annex 1 as well as requirements in Annex 3 for biological products, Annex 3-2 for radiopharmaceuticals 한다. 다만, 이 기준에서 별도로 정하거나 or Annex 3-3 for medicinal gases. However, if otherwise 임상시험용의약품의 개발단계에 따른 특성을 고려하여 specified in this Regulation or if rationale appropriate for 적정한근거가있을경우일부기준을적용하지않을수있다. development stage of the investigational medicinal product is provided, some requirements may not apply. 나. 임상시험용의약품의기준등은개발진행에따라평가등을 B. Specifications for investigational medicinal products 통해 단계에 맞게 강화되어야 하며, 각종 변경들은 should be reinforced over development stages and various 문서화되고추적가능하여야한다. kinds of changes should be documented and traceable. 다. 임상시험용의약품은제조전에별표 4의의약품임상시험관리기준과임상시험계획서등에서정하는이중눈가림, 무작위배정등이유지될수있도록충분히고려하여야한다. C. Prior to production of investigational medicinal products, double-blinding, randomization and others as specified in Good Clinical Practice Regulation in Annex 4 and clinical trial protocol should be sufficiently considered. 4. 적용범위 4. Scope 3

4 이기준은 약사법 제34조에따른임상시험에사용하는임상시험용의약품에적용하며, 시판중인의약품을대조약등의목적으로사용하기위하여재포장하거나변형하는경우에도이기준을적용한다. This Regulation applies to investigational medicinal products used in clinical trials under Article 34 of the Pharmaceutical Affairs Act. In addition, this Regulation applies to repackaging or modification of commercially available medicinal products for the purpose of using them as comparators. 5. 시설및환경의관리 5. Premise and Environment 가. 의뢰자는임상시험용의약품의제조, 시험, 포장, 보관, 운송업무의전부또는일부를위탁하는경우해당제조소의 A. If a sponsor intends to make another manufacturer perform all or some parts of production, quality control, 제조업허가여부, 제조및품질관리기준준수여부등을 packaging, storage and shipping of investigational 사전에 평가하여야 하고, 제조업자는 해당 medicinal products under contract, the sponsor should 임상시험용의약품관련제조및품질관리체계를확립하고문서화하여야한다. assess the manufacturer for manufacturing business license, compliance with GMP regulation and others in advance. In such instance, the manufacturer should establish and document production and quality control system for the investigational medicinal product. 나. 임상시험용의약품의 제조 및 시험에 사용되는 중요 B. Important facilities and equipment used in production and 기계ㆍ설비에대하여교정및적격성평가를실시하여야한다. quality control of investigational medicinal products should be calibrated and qualified. 다. 임상시험용의약품은독성, 역가등을완전히파악하기어려우므로다품목생산시에는건물및설비의설계, 세척 C. Toxicity, potency and others may not be fully understood for investigational medicinal products. Therefore, for 후검사방법및허용한도설정, 캠페인작업고려등 multi-product manufacturing sites, measures for 교차오염방지대책을마련하여야하며, 필요한경우제품의독성, 세척및제거용이성등평가를실시하여결정한다. prevention of cross-contamination, such as design of equipment and premise, test methods and acceptance limits to be used after cleaning and consideration of 4

5 campaign working, should be developed. If necessary, toxicity of product, easiness of cleaning and removal, and other aspects should be assessed. 6. 조직및역할 6. Organization and Responsibilities 가. 의뢰자는업무의전부를위탁하는경우임상시험용의약품 A. If the sponsor intends to use another manufacturer for all 해당 제조단위의 최종 출하승인 결정 등 품질보증을 operations under contract, the sponsor should have a 담당하는책임자를두어야하며, 책임자는 약사법 제36조제3항에따른제조관리자또는이기준에관한충분한지식과경험을가진사람이어야한다. person responsible for quality assurance of investigational medicinal products, such as lot release. This person responsible for quality assurance should be a qualified person as prescribed in Article 36, Paragraph 3 of the Pharmaceutical Affairs Act or a person having sufficient knowledge and experience in this Regulation. 나. 의뢰자 소속 품질 ( 보증 ) 책임자는 제7.3호의 B. The head of quality (assurance) unit belonging to the 임상시험용의약품 기준 자료집을 개정하고 제9.2호의 sponsor should revise the product specification file of 출하승인시 고려사항을 검토하여 제품 출하를 최종 section 7.3 and make a decision of lot release under 결정한다. 일부공정을위탁할경우에도동일하다. consideration of aspects as prescribed in section 9.2. This requirement should equally apply to cases where some processing steps are contracted to another manufacturer. 다. 연간품질평가와 주요 원자재 제조업자 평가는 C. Annual product quality review and critical material 임상시험용의약품의개발단계를고려하여가능한범위내에서실시한다. supplier assessment should be conducted within the limits of the possible, under consideration of development stage of investigational medicinal products. 7. 문서및기준서 7. Documentation and Specifications 5

6 7.1 기준서및지시서 7.1 Specifications and Instructions 가. 기준서 ( 출발물질, 1차 포장재, 반제품, 원료의약품 및 A. Specifications (for starting materials, primary packaging 완제의약품 ), 제품표준서, 공정지시서 및 포장지시서는 materials, intermediates, drug substances and drug 개발단계에적합하게작성하여야한다. 다만, 작업이반복되지않는경우제품표준서와공정지시서는작성하지않을수있다. products), product master file, and processing and packaging instructions should be prepared given the current development stage. However, if operations are not repeated, product master file and processing instructions may not be prepared. 나. 개발이 진행됨에 따라 가목의 문서들은 주기적으로 B. Documents of the above A should be periodically reassessed 평가하고개정하여야한다. 개정문서에는최신자료, 기술, 관련규정및공정서요건등이고려되고이전문서를추적할수있어야한다. and updated during development, as necessary. Each new version should take into account the latest data, current technology used, regulatory and pharmacopeial requirements, and should allow traceability to the previous documents. 다. 변경은제품의품질, 진행중인임상시험에미치는영향등을고려하여문서화된절차에따라실시하고, 조사결과, 근거등이기록되어야한다. C. Any changes should be carried out according to a written procedure, which should address any implications for product quality and on-going clinical trials. Investigations, rationales and others should be documented. 7.2 의뢰서 7.2 Order 의뢰자는임상시험용의약품기준자료집이나임상시험계획서를 The sponsor should prepare the order (it may be transmitted by 참고하여의뢰서를작성 ( 전자적수단으로전송가능 ) 하고사전에 electronic means) while referring to product specification file and 마련된절차에따라승인하여야한다. the relevant clinical trial protocol and approve it according to a written procedure. 6

7 7.3 임상시험용의약품기준자료집 7.3 Product Specification File 동자료집에는다음각목의사항이포함되어야하며, 필요한 This file should include the following information. If necessary, 경우 해당 문서의 목록형태로 작성할 수 있다. 또한, this file can be made in the form of a list of the relevant 임상시험용의약품의특성이나개발단계에따라차이가있을수있다. documents. In addition, the contents may vary depending on the nature of the investigational medicinal product and the development stage. 가. 출발물질, 포장재, 반제품, 원료의약품및완제의약품에대한기준및시험방법 (1) Specifications and test methods for starting materials, packaging materials, intermediates, drug substance and drug product; 나. 제조방법 (2) Manufacturing methods; 다. 공정검사방법 (3) In-process testing and methods; 라. 승인된표시재료 (4) Approved label; 마. 임상시험계획서, 무작위배정코드 ( 필요한경우 ) (5) Clinical trial protocols and randomization codes (if necessary); 바. 위탁업체와의관련계약서 ( 예 : 기술계약서, 품질협약서등 ) (6) Agreements with contract givers (e.g., technical agreements, quality agreements); 사. 안정성시험자료 (7) Stability data; 아. 보관및운송조건 (8) Storage and shipment conditions. 7.4 포장지시서 7.4 Packaging Instructions 가. 임상시험용의약품은일반적으로각시험대상자마다개별포장한다. A. Investigational medicinal products should be normally packed in an individual way for each subject in the clinical trial. 나. 포장작업전에품질관리및보관용검체를고려하여포장 B. The number of units to be packaged should be specified 7

8 수량을정하여야하며, 공정각단계마다수량확인등충분한관리가이루어져야한다. prior to the start of the packaging operations, including units necessary for quality control and any reserve samples to be kept. Sufficient controls, such as reconciliations, should take place at each stage of processing. 7.5 제조, 시험및포장기록서 7.5 Processing, Testing and Packaging Records 가. 각종기록서는작업순서를정확히확인할수있도록 A. Individual records should be kept in sufficient detail to 세부사항이기록되어야하며, 사용된절차및변경사항의 allow accurate determination of the sequence of 타당성을제시하는관련설명이포함되어야한다. operations. These records should contain any relevant remarks which justify procedures used and any changes made. 나. 각종기록서는해당제조단위가사용된임상시험종료후 5년이상보관하여야한다. B. Records should be retained for at least 5 years after completion of clinical trial in which the relevant lot of investigational medicinal product was used. 8. 제조 8. Production 8.1 제조작업과밸리데이션 8.1 Production Operations and Validation 가. 임상시험용의약품의 공정 밸리데이션은 시판용 제조에 A. Production processes for investigational medicinal 필요한범위로실시할필요는없으며, 개발진행정도등을고려하여가능한범위내에서실시할수있다. products may not be validated to the extent necessary for commercial production. Validation of production processes for investigational medicinal products may be appropriately performed within the limits of the possible, under consideration of development stage. 8

9 나. 무균제제의경우무균성공정밸리데이션을실시하여야한다. 다. 생물학적제제등은필요한경우바이러스불활화또는제거, 생물유래불순물의불활화또는제거등이입증되어야한다. B. For sterile products, sterilization processes should be validated. C. For biological products, when required, virus inactivation or removal and inactivation or removal of impurities of biological origin should be demonstrated. 8.2 대조약에적용되는원칙 8.2 Principles Applicable to Comparator Product 가. 시판제품을변형시키는경우제품품질의특성에영향을 A. If a commercially available product is modified, data 미치지 않음을 증명하는 자료 ( 안정성, 비교용출, should be available (e.g., stability, comparative dissolution, 생체이용률등 ) 가있어야한다. bioavailability) to demonstrate that these changes do not alter the quality characteristics of the product. 나. 대조약의최초포장에표시된유효기한또는사용기한은다른용기에재포장되는경우에는적용하지않을수있다. B. The expiry or shelf-life date stated for the comparator product in its original packaging may not be applicable to 의뢰자는 타당한 근거에 따라 적절한 유효기한 또는 the product where it has been repackaged in a different 사용기한을설정하여야한다. container. The sponsor should determine a suitable expiry or shelf-life date, taking into account reasonable rationales. 다. 대조약의유효기한또는사용기한은최초포장에표시된유효기한또는사용기한을초과할수없으며, 임상시험기간에적합하여야한다. C. The comparator product's expiry or shelf-life date should not be later than the expiry or shelf-life date of the original package. There should be compatibility of expiry date and clinical trial duration. 8.3 포장공정관리 8.3 Packaging Operations 가. 기준문서와품질관리확인시포장재의서로다른 A. Specifications and quality control checks should include 제조단위의외형상변경등에따른의도하지않은눈가림 measures to guard against unintentional unblinding due 9

10 해제를방지할수있는방안을마련하여야한다. 나. 임상시험용의약품의포장과라벨은외관이유사한눈가림제품들이사용되는경우작업오류를방지하기위한추가조치를마련하여야한다. 다. 눈가림이필요한제품은제조번호를포함한제품의식별이가능할수있으나, 반드시작업전에눈가림유지등을위한방안을갖추어야한다. 비상시에는제품의신속한식별이가능하여야한다. 라. 임상시험용의약품의포장에사용되는무작위배정코드의생성, 보안, 배포, 취급및유지와코드해제방법에대한절차를문서화하여야하며, 기록을작성하고보관하여야한다. 마. 유효기한또는사용기한의변경이필요한경우추가로표시할수있다. 추가로표시하고자하는경우새로운유효기한또는사용기한및최초의제조번호를동일하게표시하되최초의제조번호위에는표시하지않는다. 바. 추가표시사항부착은적절한제조소에서실시되어야하나, 정당한사유가있을경우임상시험실시기관에서실시할수 to changes in appearance between different lots of packaging materials. B. When blinded products with similar appearance are used, additional measures to prevent potential errors should be provided for packaging and labelling of investigational medicinal products. C. Where products are blinded, systems should be in place to ensure that the blinding is achieved and maintained while allowing for identification of blinded products when necessary, including the lot numbers of the products, before the blinding operation. Rapid identification of product should also be possible in an emergency. D. There should be written procedures for generation, security, distribution, handling and retention of any randomization code used for packaging investigational medicinal products, and code-break mechanisms. Appropriate records should be maintained. E. If it is necessary to change the expiry or shelf-life date, an additional label may be affixed to the investigational medicinal product. This additional label should state the new expiry or shelf-life date and original lot number. This label should not be superimposed on the original lot number. F. Attachment of additional labels should be performed at an appropriate manufacturing site. However, when justified, 10

11 있다. 이경우의뢰자는실시기관이적절히수행및기록하도록이중점검등문서화된절차를제공하여야한다. 사. 임상시험용의약품은보관조건에따라운송및보관되고외부포장의개봉또는훼손시쉽게알수있도록포장되어야한다. it may be performed at the investigational site. In such instance, the sponsor should provide written procedures, including double-checking, to assure such operation is appropriately conducted and documented. G. The packaging should ensure that the investigational medicinal product remains in good condition during transport and storage. Any opening or tampering of outer packaging should be readily identifiable. 9. 품질관리 9. Quality Control 9.1 시험관리 9.1 Laboratory Control 가. 품질관리는 임상시험용의약품 기준 자료집 등에 따라 A. Quality control should be performed in accordance with 실시하여야하며, 눈가림효과를확인하고기록하여야한다. the product specification file and the effectiveness of blinding should be assessed and recorded. 나. 보관용검체등은해당제조단위의임상시험종료후 2년이상보관하여야한다. B. Reserve samples should be kept for at least 2 years after completion of the last clinical trial in which the lot was used. 다. 시험방법밸리데이션은개발단계에따라실시하되제3상임상시험실시전에완료하는것을원칙으로한다. C. The degree of analytical method validation may vary depending on development stage. However, analytical method validation should be completed prior to the start of phase 3 clinical trial. 9.2 임상시험용의약품최종출하승인 9.2 Release of Investigational Medicinal Products 제 6 호나목의의뢰자소속품질 ( 보증 ) 책임자는다음사항들을 The head of quality (assurance) unit belonging to the sponsor as 11

12 검토하여적합할경우최종출하승인한다. prescribed in section 6-B should review the following information and make a decision of lot release when requirements are met. (1) 각종기록서가임상시험용의약품기준자료집, 의뢰서, (1) Records demonstrating compliance with product 필요한경우임상시험계획서, 무작위배정코드와부합하는지여부 ( 모든일탈, 계획된변경및추가확인사항, 시험결과와시험자, 판정자등의서명포함 ) specification file, order, clinical trial protocol (if necessary) and randomization code (including all deviations, planned changes and any consequent additional checks, test results and signatures of persons who conducted testing and made a decision); (2) 제조조건 (2) Production conditions; (3) 시설, 공정및시험방법의밸리데이션상태 (3) Validation status of facilities, processes and test methods; (4) 최종포장검사 (4) Examination of finished packs; (5) 필요한경우수입후수행된분석또는시험결과 (5) If necessary, results of any analyses or tests performed after importation ; (6) 안정성시험보고서 (6) Stability reports; (7) 제조원및보관과운송조건확인 (7) The manufacturer and verification of conditions of storage and shipment; (8) 제조업자점검보고서 (8) Reports on audit of the manufacturer; (9) 임상시험용의약품 ( 대조약 포함 ) 수출 허가 등 적절한 (9) Documents certifying that the investigational medicinal 절차를확인할수있는서류 products (including comparator) are authorized for export or other documents for verification of appropriate procedures; (10) 해당하는경우외국규제요건, 적용기준및제조및 (10) Where relevant, overseas regulatory requirements, 품질관리기준증명서 applicable regulations and GMP compliance certificate; (11) 기타제조단위의품질관련자료 (11) All other information relating to the quality of the lot. 12

13 9.3 안정성시험 9.3 Stability Testing 가. 안정성시험은자체수립한계획또는제24조제1항에따라식품의약품안전처장에게제출한안정성시험계획에따라 A. Stability testing should be performed according to the established plan or the stability testing plan submitted to 실시하고 그 결과 등을 근거로 임상시험용의약품의 the Minister of Food and Drug Safety pursuant to Article 유효기한 또는 사용기한, 포장방법 및 저장조건을 24, Paragraph 1 and stability data should be used to 설정하여야한다. establish expiry or shelf-life period, packaging method and storage conditions of an investigational medicinal product. 나. 임상시험용의약품은 1개 이상의 제조단위에 대하여 B. Long-term stability testing should be performed with more 장기보존시험등을하여야하며, 시험결과제품의품질에 than one lot of an investigational medicinal product and, if 영향을 미치는 경우에는 유효기한 또는 사용기한을 stability data indicates any effect on product quality, the 조정하여야한다. expiry or shelf-life period should be accordingly adjusted. 다. 사용기간 연장을 진행할 경우 제24조제1항에 따라 C. If it is intended to extend the expiry period, the stability 식품의약품안전처장에게제출한안정성시험계획에따라안정성시험을실시하고, 품질에문제가발생할경우시정조치계획등을첨부하여신속히보고하여야한다. testing should be performed according to the stability testing plan submitted to the Minister of Food and Drug Safety pursuant to Article 24, Paragraph 1. If any quality issue is observed, it should be reported as soon as possible together with corrective action plan. 10. 원자재및제품의관리 10. Control of Materials and Products 가. 임상시험용의약품을취급하는작업원은취급시눈가림이 A. Personnel engaged in handling of investigational 유지될수있도록적절한절차를마련하여문서화하고이를준수하여야한다. medicinal products should follow written procedures designed to assure maintenance of blinding. 나. 실시기관간의임상시험용의약품이동은타당한사유가 B. Transfers of investigational medicinal products from one 있을 경우로 제한되며, 제6호나목의 의뢰자 소속 trial site to another should be allowed only when there are 품질 ( 보증 ) 책임자는의뢰자관리를벗어난기간동안해당 justifiable reasons. There should be written procedures 13

14 임상시험용의약품의이력등을검토하여사용가능여부를결정하는등절차를문서화하여야한다. 다. 제조소에서임상시험용의약품의표시사항재부착작업을하는경우제6호나목의의뢰자소속품질 ( 보증 ) 책임자의승인이필요하며, 관련기록등전과정이추적가능하여야한다. designed to assure that the head of quality (assurance) unit belonging to the sponsor as prescribed in section 6-B reviews the product history while outside of the control of the sponsor to approve use of such investigational medicinal products. C. If investigational medicinal products are re-labelled at the manufacturing site, the head of quality (assurance) unit belonging to the sponsor as prescribed in section 6-B should approve it. Records should be retained and full traceability ensured. 11. 불만처리, 회수, 반품, 및폐기 11. Complaints, Recalls, Returns and Destruction 가. 의뢰자는 제품 품질 관련 불만이 있으면 임상시험, A. The sponsor should investigate any complaint relating to 시험대상자및제품개발에미치는영향들을조사하여야하며, 의뢰자와제조업자가다른경우조사방법등에대해협의하는절차를문서화하여야한다. the quality of the product to identify any potential impact on clinical trial, subjects and product development. There should be a procedure for discussion of investigations between the manufacturer and the sponsor (if different). 나. 의뢰자는 임상시험용의약품 회수 절차를 문서화하여야 B. The sponsor should have written procedures for recall of 하며, 제조업자, 시험자와모니터요원등의역할과의무 investigational medicinal products. Roles and 등을포함하여야한다. responsibilities of manufacturer, clinical investigators, monitors and others should be included in such written procedures. 다. 의뢰자는임상시험에사용되는대조약등의공급자로부터공급제품의회수필요성을통보받는시스템을갖추고있어야한다. C. The sponsor should have a system to assure that the supplier of any comparator or others to be used in a clinical trial communicates to the sponsor the need to 14

15 라. 의뢰자는별표 4 의약품임상시험관리기준제8호거목에 따라실시기관으로부터사용하지않은임상시험용의약품의 반납관련절차를문서화하여야한다. 또한임상시험기간 동안 실시기관에 공급, 사용 또는 반납된 임상시험용의약품의 수량을 확인하고 기록을 작성ㆍ보관하여야한다. 마. 의뢰자는반납받거나사용하지않은임상시험용의약품은 별도의 지정된 장소에 보관하고 사전에 문서화된 폐기절차에 따라 폐기 관련 법령 등을 준수하여 폐기하여야한다. 근거자료와임상시험용의약품의제품명, 제조번호, 유효기한또는사용기한, 반납한실시기관명, 시험대상자번호 ( 또는무작위배정코드 ), 실제폐기수량 등폐기에관한기록을임상시험별로작성ㆍ보관하여야 한다. recall any product supplied. D. The sponsor should have written procedures for return of any remaining investigational medicinal products from trial sites in accordance with 8-O of Good Clinical Practice Regulation in Annex 4. In addition, the sponsor should reconcile quantities of investigational medicinal products supplied, used and returned during clinical trial period and records on such reconciliation should be prepared and kept. E. The sponsor should store investigational medicinal products returned or not used in a separately designated area and destroy them according to written procedures and in compliance with applicable laws and regulations. Records on destruction of investigational medicinal products, such as product name, lot number, expiry or shelf-life date, trial sites which returned investigational medicinal products, subject codes (or randomization codes), and quantity of products actually destroyed as well as supporting documents should be maintained for individual clinical trials. 12. 교육및훈련 12. Education and Training 무작위배정코드취급, 포장공정관리등작업원이해당업무를 Personnel should be trained in handling of randomization codes, 수행할수있도록필요한임상시험관련교육을실시하여야 packaging operations and others relating to clinical trials to 한다. assure that they perform their assigned functions. 15

16 13. 실태조사등 13. Inspection 13.1 실태조사실시 13.1 Conduct of Inspection 식품의약품안전처장은진행중또는종료된임상시험에대해서 For on-going or completed clinical trials, the Minister of Food 의뢰자 또는 제조업자가 이 기준에 따라 적절히 and Drug Safety may perform inspection to verify if the sponsor 임상시험용의약품제조및품질관리를수행하였는지여부를판정하기위하여실태조사를실시할수있다. or the manufacturer performed production and quality control of investigational medicinal product in compliance with this Regulation 실태조사경비 13.2 Inspection fee 의뢰자는수익자부담원칙에따라실태조사에필요한경비의전부 The sponsor should pay all or part of expenses needed for 또는일부를부담한다. inspection according to the "Benefiter Pays Principle" 기타 13.3 Others 식품의약품안전처장은이기준을실시하기위하여이기준의 The Minister of Food and Drug Safety may define detailed 실시에관한세부사항을정할수있다. procedures and requirements for implementation of this Regulation. 16

ISO17025.PDF

ISO17025.PDF ISO/IEC 17025 1999-12-15 1 2 3 4 41 42 43 44, 45 / 46 47 48 49 / 410 411 412 413 414 5 51 52 53 54 / 55 56 57 58 / 59 / 510 A( ) ISO/IEC 17025 ISO 9001:1994 ISO 9002:1994 B( ) 1 11 /, / 12 / 1, 2, 3/ (