Microsoft Word - ICH Q7 API GMP Guide

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1 1. 서론 (INTRODUCTION) 1.1 목적 (Objective) This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. 이문서 ( 가이드 ) 는적절한품질관리시스템에서활성제약성분 (API) 제조를위한 GMP 관련가이드라인을제공하기위한것이다. 또한 API가보유하는것으로주장하거나표시된품질과순도기준에부합하도록하기위한것이다. In this Guide "manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls. In this Guide the term "should indicates recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at least an equivalent level of quality assurance. For the purposes of this Guide, the terms "current good manufacturing practices and "good manufacturing practices are equivalent. The Guide as a whole does not cover safety aspects for the personnel engaged in the manufacture, nor aspects of protection of the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws. 이가이드에서 제조 (manufacturing) 라함은물품의인수, 생산, 포장, 재포장, 라벨링, 재라벨링, 품질관리, 출하승인, 보관, 유통및관련관리활동모두를포함하는것으로정의된다. 이가이드에서 should 는적용대상이아니거나적어도동등한수준의품질보증을제공하는것으로증명된다른방법으로대체되지않는한, 적용할것으로기대하는권고사항을의미한다. 이가이드에서 "CGMP(Current Good Manufacturing Practices)" 와 "GMP(Good Manufacturing Practices)" 는동등한것이다. 전체적으로이가이드는제조작업자의안전문제나환경보호부분은다루지않는다. 이런부분은제조업체의고유한책임이며국가별관련법규에따라규제된다. 7

2 This Guide is not intended to define registration/filing requirements or modify pharmacopoeial requirements. This Guide does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents must be met. 이가이드는등록 / 신고기준을규정하거나약전기준의변형을위한것이아니다. 이가이드는시판 / 제조허가나의약품신청과관련하여 API에관한구체적인등록 / 신고기준을설정하는해당규제기관의권한에영향을미치지않는다. 등록 / 신고문서의모든사항을준수해야한다. 1.2 법적적용 (Regulatory Applicability) Within the world community, materials may vary as to the legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this Guide. 법적으로 API로분류되는물품은국가에따라다를수있다. 어떤물품이제조된지역이나국가또는그물품이의약품생산에투입된지역이나국가에서그물품을 API로분류한다면, 이가이드에따라제조되어야한다. 1.3 적용범위 (Scope) This Guide applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidelines for drug (medicinal) products as defined by local authorities. 이가이드는사람의약품제조에사용되는 API의제조에적용된다. 무균 API 제조의경우에는 API를무균상태로만들기직전까지적용된다. 무균 API의멸균및무균공정은이가이드의대상이아니며, 규제기관이정한의약품 GMP 가이드라인을따라야한다. This Guide covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or 8

3 by any combination of these processes. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section 18. 이가이드는화학적합성, 추출, 세포배양 / 발효, 또는천연물로부터의회수, 또는이들공정의조합에의해제조되는 API를대상으로한다. 세포배양 / 발효에의해제조되는 API에관한구체적인사항은 18항에서다루고있다. This Guide excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this Guide. In addition, the Guide does not apply to medical gases, bulkpackaged drug (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals. 모든백신, 전세포, 전혈및혈장, 혈액및혈장유래제품 ( 혈장분획 ), 유전자치료제 API는이가이드의적용대상에서제외된다. 하지만혈액또는혈장을원료로사용해생산된 API는적용대상에포함된다. 세포기질 ( 포유류, 식물, 곤충또는미생물세포, 조직또는형질전환동물을포함한동물유래 ) 및초기공정단계에 GMP가적용될수있으나이가이드의대상은아니다. 이외에도의료용가스, 벌크포장의약품, 방사성의약품관련제조 / 관리에는이가이드가적용되지않는다. Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products). 19항에는특히임상시험을위한의약품 ( 임상시험의약품 ) 의생산에사용되는 API의제조와관련된가이드라인이기술되어있다. An "API Starting Material is a raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials normally have defined chemical properties and structure. 9

4 "API 출발물질 " 은 API 생산에사용되는것이며중요한구조적부분으로 API 구조에통합되는원료, 중간제품또는 API를의미한다. API 출발물질을시중에서구입하거나계약또는합의에따라하나이상의공급업체로부터구입하거나자체적으로생산할수있다. API 출발물질은일반적으로화학적특징과구조가규명되어있다. The company should designate and document the rationale for the point at which production of the API begins. For synthetic processes, this is known as the point at which "API Starting Materials" are entered into the process. For other processes (e.g. fermentation, extraction,, etc), this rationale should be established on a case-by-case basis. Table 1 gives guidance on the point at which the API Starting Material is normally introduced into the process. 업체는 API 생산이시작되는부분을정하고그근거를문서화해야한다. 합성공정인경우에이부분은 API 출발물질 이공정에도입되는시점에해당된다. 다른공정 ( 예, 발효, 추출, 정제등 ) 인경우에는상황별로그근거를설정한다. 일반적으로 API 출발물질이공정에도입되는시점에관한가이드라인이표 1에정리되어있다. From this point on, appropriate GMP as defined in this Guide should be applied to these intermediate and/or API manufacturing steps. This would include the validation of critical process steps determined to impact the quality of the API. However, it should be noted that the fact that a company chooses to validate a process step does not necessarily define that step as critical. 이시점부터이가이드에규정된적절한 GMP 기준을중간제품및 / 또는 API 제조단계에적용한다. API의품질에영향을주는것으로확인된중요공정단계의밸리데이션도실시한다. 그러나어떤공정단계를밸리데이션하기로결정했다고해서, 그공정단계가반드시중요한단계라는의미는아니다. The guidance in this document would normally be applied to the steps shown in gray in Table 1. It does not imply that all steps shown should be completed. The stringency of GMP in API manufacturing should increase as the process proceeds from early API steps to final steps,, and packaging. processing of APIs, such as granulation, coating or physical manipulation of particle size (e.g. milling, micronizing), should be 10

5 conducted at least to the standards of this Guide. 이문서의가이드라인은일반적으로표1의회색으로표시된단계에적용된다. 그렇다고이표의모든단계를실시해야한다는의미는아니다. 공정이초기단계에서정제및포장등마지막단계로갈수록, API 제조에적용되는 GMP 기준을더욱강화된다. 과립화, 코팅또는입자크기의물리적조작 ( 예, 밀링, 마이크로나이징 ) 같은 API의물리적처리공정은적어도이가이드의기준에따라실시한다. This GMP Guide does not apply to steps prior to the introduction of the defined "API Starting Material". 이 GMP 가이드는지정 API 출발물질 의투입이전단계에적용되지않는다. 11

6 Table 1: Application of this Guide to API Manufacturing Type of Manufacturing Application of this Guide to steps used in this type of manufacturing Chemical Production of the Production of Manufacturing API Starting the API Intermediate(s) Material Starting Material into process API extracted Cutting and from plant plant initial the API Starting sources extraction(s) Material into process API derived Cutting, from animal organ, fluid, or mixing, and/or the API Starting sources tissue initial Material into processing process Biotech/ Establishment of Maintenance Cell culture fermentation master cell bank of working cell and/or cell culture and working cell bank fermentation bank "Classical" Establishment of Maintenance Fermentation cell bank of the cell the cells into to produce an bank fermentation API API consisting Cutting/ of plants and/or comminuting comminuted cultivation and or powdered harvesting herbs Herbal Cutting and Further extracts used plants initial extraction as API extraction GMP 기준적용강화 12

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