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1 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL 브뤼셀, 2013 년 8 월 16 일 EudraLex The Rules Governing Medicinal in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal for Human and Veterinary Use Part 1 Chapter 2: 작업자 (Personnel) Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use and Article 51 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products. This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. 세부가이드라인발행의법적근거 : 사람의약품관련 EC 법률에관한디렉티브 2001/83/EC의 47조와동물의약품관련 EC 법률에관한디렉티브 2001/82/EC의 51조. 이문서는사람의약품에대한디렉티브 2003/94/EC와동물의약품에대한디렉티브 91/412/EEC에규정된의약품 GMP의원칙과가이드라인의해석을위한지침을제공한다. Status of the document: Revision 문서상태 : 개정 Reasons for changes: Changes have been made in order to integrate the principles of Pharmaceutical Quality System as described in the ICH Q10 tripartite guideline. A section has been added on consultants 변경이유 : ICH 10 " 제약품질시스템 " 의원칙에맞춰변경했다. 컨설턴트관련항목을추가했다. 1

2 Deadline for coming into operation: 16 February 2014 시행일자 : 2014년 2월 16일 2

3 원칙 (Principle) The correct manufacture of medicinal products relies upon people. For this reason there must be sufficient qualified personnel to carry out all the tasks which are the responsibility of the manufacturer. Individual responsibilities should be clearly understood by the individuals and recorded. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs. 의약품의올바른제조는사람에게달려있다. 그렇기때문에제조업체의책임업무모두를수행하기위하여자격을갖춘작업자가충분히있어야한다. 개개인의책임업무를당사자가명확히이해해야하며, 기록해야한다. 모든작업자가자신과관련된 GMP 원칙을인지해야하며, 위생관리를포함하여각자의필요에맞는교육훈련을입사당시는물론이고이후에도지속적으로받아야한다. 공통 (General) 2.1 The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. Senior management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the quality management system and continually improve its effectiveness. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality. 제조업체는필수적인자격과실무경험을갖춘적절한수의작업자를구비해야한다. 고위경영자는품질경영시스템을구축하고유지하며, 품질경영시스템의효과를지속적으로향상시키는데필요한자원 ( 사람, 돈, 물품, 시설, 설비 ) 을파악하고제공한다. 각개인에게부여된책임업무가너무많아품질에리스크가되는상황이발생해서는안된다. 2.2 The manufacturer must have an organisation chart in which the relationships between the heads of Production, Quality Control and where applicable Head of Quality Assurance or Quality Unit referred to in point 2.5 and the position of the Qualified Person(s) are clearly shown in the managerial hierarchy. 제조업체는생산부서의장, 품질관리부서의장, 그리고해당되는경우에는 2.5항의품질보증또는품질조직의장사이의관계와 QP(Qualified Person) 의 3

4 위치를관리계층구조방식으로명확히보여주는조직도를구비해야한다. 2.3 People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. Their duties may be delegated to designated deputies of a satisfactory qualification level. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice. 책임있는지위에있는사람의구체적인직무를문서화하며, 책임업무를수행하는데필요한권한을적절하게구비해야한다. 이들의업무를만족할만한자격을갖춘지정된자에게위임할수있다. GMP 운영과관련된사람의책임업무에설명되지않는중첩부분이나공백이있어서는안된다. 2.4 Senior management has the ultimate responsibility to ensure an effective quality management system is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the quality management system and GMP compliance through participation in management review. 효과적인품질경영시스템을구비하여품질목표를달성하고, 역할과책임, 권한을규정해조직전체에전파하고구축할궁극적인책임이고위경영자에게있다. 고위경영자는품질과관련된전반적인의도와방향을규정한품질방침을확립하고, 경영검토에참여함으로써품질경영시스템의지속적인적합성과효과, 그리고 GMP 기준준수실태를확인한다. 주요책임자 (Key Personnel) 2.5 Senior Management should appoint Key Management Personnel including the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the duties described in Article 51 of Directive 2001/83/EC 1, an adequate number, but at least one, Qualified Person(s) designated for the purpose. Normally, key posts should be occupied by full- 1 Article 55 of Directive 2001/82/EC 4

5 time personnel. The heads of Production and Quality Control must be independent from each other. In large organisations, it may be necessary to delegate some of the functions listed in 2.6 and 2.7. Additionally depending on the size and organisational structure of the company, a separate Head of Quality Assurance or Head of the Quality Unit may be appointed. Where such a function exists usually some of the responsibilities described in 2.6, 2.7 and 2.8 are shared with the Head of Quality Control and Head of Production and senior management should therefore take care that roles, responsibilities, and authorities are defined. 고위경영자는생산부서의장, 품질관리부서의장, 그리고이중에서적어도한명이디렉티브 2001/83/EC의 51조에규정된업무를책임지지않는경우에는그업무를위해한명이상의 QP(Qualified Person) 를포함해중요관리책임자를임명해야한다. 일반적으로상근자가주요지위의업무를맡아야한다. 생산및품질관리부서의장은서로독립되어있어야한다. 큰조직에서는 2.6과 2.7에기술된업무의일부를위임할필요가있을것이다. 또한회사의규모와조직구조에따라, 품질보증부서의장또는품질조직의장을별도로임명할수있다. 이와같은조직을구비한다면, 2.6, 2.7, 2.8의책임업무가운데일부를품질관리부서와생산부서의장과공유하며, 그러므로고위경영자는역할과책임, 권한을신중하게규정해야한다. 2.6 The duties of the Qualified Person(s) are described in Article 51 of Directive 2001/83/EC, and can be summarised as follows: QP의업무는디렉티브 2001/83/EC의 51조에자세히규정되어있으며, 그내용을다음과같이요약할수있다. a) for medicinal products manufactured within the European Union, a Qualified Person must ensure that each batch has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorisation 2 ; 2 According to Article 51 paragraph 1 of Directive 2001/83/EC, the batches of medicinal products which have undergone such controls in a Member State shall be exempt from the controls if they are marketed in another Member State, accompanied by the control reports signed by the qualified person. 디렉티브 2001/83/EC의 51조 1항에따라, 특정회원국에서이와같은관리절차를 5

6 (b) EU에서제조된의약품인경우, QP는해당회원국의법률과판매허가기준에따라각배치를제조하고점검했는지확인한다. in the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the European Union a Qualified Person must ensure that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation. The Qualified Person must certify in a register or equivalent document, as operations are carried out and before any release, that each production batch satisfies the provisions of Article 51. 제3국에서수입되는의약품인경우, 그제품이 EU에서제조되었는지여부와상관없이, 생산배치별로정성적분석전체와최소한모든활성성분의정량적분석, 그리고판매허가기준에따라의약품의품질을보증하는데필요한기타시험이나점검을회원국에서실시했는지 QP가확인한다. QP는업무를진행하면서, 그리고출하승인에앞서각생산배치가 51조의기준을충족함을등록부 (register) 또는그와동등한문서에기록하고증명한다. The persons responsible for these duties must meet the qualification requirements laid down in Article 49 3 of the same Directive, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities. 이업무를책임지는자는상기디렉티브 49조에규정된자격기준을만족해야하며, 제조허가보유자의결정에따라영구적이고연속적으로책임업무를수행해야한다. The responsibilities of a Qualified Person may be delegated, but only to other Qualified Person(s). QP의책임업무를위임할수있지만, 다른 QP에게만위임이가능하다. Guidance on the role of the Qualified Person is elaborated in Annex 거친의약품배치를다른회원국에서판매하고자할때, QP 가서명한관리보고서가 있으면관리절차의면제가적용된다. Article 53 of Directive 2001/82/EC 6

7 QP 의역할에관한자세한사항은부록 16 을참조한다. 2.7 The head of the Production Department generally has the following responsibilities: 생산부서의장은일반적으로다음업무를책임진다. i. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality; 필요품질을확보하기위해적절한문서에따라제품을생산하고보관하도록한다. ii. To approve the instructions relating to production operations and to ensure their strict implementation; 생산작업과관련된지시문서를승인하고이지시문서를철저하게준수하도록한다. iii. To ensure that the production records are evaluated and signed by an authorised person; 생산기록서를허가받은자가평가하고서명하게한다. iv. To ensure the qualification and maintenance of his department, premises and equipment; 그의부서, 시설, 설비의적격성평가와유지관리를책임진다. v. To ensure that the appropriate validations are done; 적절하게밸리데이션을하도록한다. vi. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. 부서원에대해최초교육훈련및지속적교육훈련을실시하고필요에따라교육훈련내용을조정하게한다. 2.8 The head of Quality Control generally has the following responsibilities: 품질관리부서의장은다음업무를책임진다. i. To approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products; 출발물질, 포장자재, 중간제품, 벌크제품, 최종제품의적합성을평가하고승인하거나부적합결정을내린다. ii. To ensure that all necessary testing is carried out and the associated records evaluated; 필수적인모든시험을실시하고관련기록을평가하게한다. 7

8 iii. To approve specifications, sampling instructions, test methods and other Quality Control procedures; 규격문서, 검체채취지시문서, 시험방법, 기타품질관리절차문서를승인한다. iv. To approve and monitor any contract analysts; 수탁시험자를승인하고모니터한다. v. To ensure the qualification and maintenance of his department, premises and equipment; 그의부서, 시설, 설비의적격성평가와유지관리를책임진다. vi. To ensure that the appropriate validations are done; 적절하게밸리데이션을하도록한다. vii. To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need. 부서원에대해최초교육훈련및지속적교육훈련을실시하고필요에따라교육훈련내용을조정하게한다. Other duties of Quality Control are summarised in Chapter 6. 품질관리부서의기타업무는 6장에요약되어있다. 2.9 The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the quality management system. These may include, subject to any national regulations: 생산부서의장, 품질관리부서의장, 그리고해당되는경우에는품질보증부서의장이나품질조직의장은, 특히품질경영시스템의디자인, 효과적인구축, 모니터, 유지관리를포함하여, 품질과관련된책임업무를일반적으로일부공유하거나공동으로책임진다. 이에해당되는업무는각국규정에따라다르지만다음사항을포함한다. i. The authorisation of written procedures and other documents, including amendments; 개정을포함하여절차문서와기타문서의승인 ii. The monitoring and control of the manufacturing environment; 제조환경모니터및관리 8

9 iii. Plant hygiene; 시설위생 iv. Process validation; 공정밸리데이션 v. Training; 교육훈련 vi. The approval and monitoring of suppliers of materials; 물품공급업체승인및모니터 vii. The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities; 수탁제조업체와기타 GMP 관련아웃소싱업체의승인및모니터 viii. The designation and monitoring of storage conditions for materials and products; 물품과제품의보관조건지정및모니터 ix. The retention of records; 기록서보관 x. The monitoring of compliance with the requirements of Good Manufacturing Practice; GMP 기준준수실태모니터 xi. The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality; 제품품질에영향을줄수있는요소의모니터를위한실사, 조사, 검체채취 xii. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement 공정성능, 제품품질, 품질경영시스템의경영검토참여및지속적개선추진 xiii. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. 품질관련문제를적절한수준의경영자에게효과적이고적시에보고하는절차구비 교육훈련 (Training) 9

10 2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product. 제조업체는업무때문에생산및보관지역이나품질관리시험실을출입하는모든작업자 ( 기술자, 유지관리작업자및세척작업자포함 ) 와제품품질에영향을줄수있는업무를하는기타작업자에대해교육훈련을실시해야한다 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept. 품질경영시스템과 GMP의이론과실무에대한기초교육훈련이외에도, 신입사원에대해서는각자에부여된업무에맞는적절한교육훈련을실시한다. 지속적인교육훈련또한실시하며, 교육훈련의실무적효과를주기적으로평가한다. 교육훈련프로그램이있어야하며, 상황에따라생산부서의장이나품질관리부서의장이교육훈련프로그램을승인한다. 교육훈련기록서를보관해야한다 Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training. 고활성, 독성, 감염성, 감작성물품을취급하는지역이나청정지역과같이오염이발생하면위험할수있는지역에서근무하는작업자를상대로그에맞는교육훈련을실시한다 Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised. 방문자나교육훈련을받지않은작업자가생산및품질관리지역에들어가지못하게하는것이바람직하다. 불가피한경우에는특히개인위생과지정보호 10

11 복장에관한정보를이들에게제공해야한다. 이들을철저하게감독한다 The pharmaceutical quality system and all the measures capable of improving its understanding and implementation should be fully discussed during the training sessions. 제약품질시스템과제약품질시스템의이해및구축을증진시킬수있는모든대책을교육훈련시에충분히다루어야한다. 개인위생 (Personnel Hygiene) 2.15 Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions. 구체적인위생프로그램을수립하고공장내부의다양한필요에맞춰조정한다. 이때작업자건강, 위생업무, 복장과관련된절차도포함하여프로그램을수립한다. 업무때문에생산지역과관리지역을출입하는모든사람이이절차를이해하고철저하게준수해야한다. 경영자가위생프로그램준수를촉진하고교육훈련시에위생프로그램을광범위하게다루어야한다 All personnel should receive medical examination upon recruitment. It must be the manufacturer s responsibility that there are instructions ensuring that health conditions that can be of relevance to the quality of products come to the manufacturer s knowledge. After the first medical examination, examinations should be carried out when necessary for the work and personal health. 작업자채용시에건강검진을실시한다. 제조업체는제품품질과관련이있는건강상태를보고하도록지도할책임이있다. 최초건강검진이후에도작업과개인건강을위해필요하면검진을실시한다 Steps should be taken to ensure as far as is practicable that no person affected by an infectious disease or having open lesions on the exposed 11

12 surface of the body is engaged in the manufacture of medicinal products. 감염성질병에걸린사람또는신체의노출부위에병소가있는사람이의약품 제조에관여하지못하도록가능한모든조치를취한다 Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out. 제조지역에들어가는모든사람은해당업무에적절한보호복장을착용해야한다 Eating, drinking, chewing or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or in any other area where the product might be adversely affected should be forbidden. 생산및보관지역에서음식을먹거나음료수를마시거나껌을씹거나담배를피우거나, 음식물, 음료수, 흡연물품또는개인의약품을보관해서는안된다. 일반적으로제조지역이나제품이부정적영향을받을수있는기타모든지역에서비위생적행위를금지해야한다 Direct contact should be avoided between the operator s hands and the exposed product as well as with any part of the equipment that comes into contact with the products. 제품과접촉하는설비부분및노출된제품과작업자의손이직접접촉하지않도록한다 Personnel should be instructed to use the hand-washing facilities. 작업자에게수세시설의사용방법을지도한다 Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the annexes. 무균제품같이특별한제품의제조에적용되는구체적인기준은부록을참고한다. 컨설턴트 (Consultants) 2.23 Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are 12

13 retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants. 컨설턴트는해당주제에대해조언을할수있는적절한교육, 교육훈련, 경험또는이들의조합을구비해야한다. 컨설턴트가제공한서비스의종류와컨설턴트의이름, 주소, 자격에관한사항을기술한기록서를구비한다. 13

Microsoft Word - template for the written confirmation for active substances exported to the EU

Microsoft Word - template for the written confirmation for active substances exported to the EU Brussels, 10/07/2012 SANCO/SF/sl/ddg1.d.6(2012)997444 Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use, in accordance with