Microsoft Word - ICH Q7 API GMP Guide

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1 6.7 배치생산기록서검토 (Batch Production Record Review) 6.70 Written procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labelling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed. 배치의출하승인또는유통에앞서, 중간제품이나 API가설정규격에부합하는지결정하기위해, 포장및라벨링을포함하여배치생산및시험관리기록을검토하고승인하는절차문서를확립하고이를준수해야한다 Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. Production and laboratory control records of noncritical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit(s). API 배치의출하승인또는유통에앞서, 주요공정단계의배치생산및시험관리기록서를품질조직 (QU) 이검토하고승인한다. 중요하지않은공정단계의생산및시험관리기록서는품질조직 (QU) 이승인한절차에따라적합한자격을갖춘생산작업자나다른부서가검토할수있다 All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released. 배치출하승인에앞서모든일탈사항, 조사내용, OOS 보고서를배치기록서검토의일환으로검토한다 The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company. 제조사의관리범위밖으로나가는경우를제외하고, 품질조직 (QU) 이중간제품의승인책임과권한을생산부서에위임할수있다. 7. 물품관리 (MATERIALS MANAGEMENT) 7.1 공통 (General Controls) 7.10 There should be written procedures describing the receipt, identification, 42

2 quarantine, storage, handling, sampling, testing, and approval or rejection of materials. 물품의인수, 확인, 격리보관, 보관, 취급, 검체채취, 시험, 적 / 부판정절차를기술한절차문서를구비한다 Manufacturers of intermediates and/or APIs should have a system for evaluating the suppliers of critical materials. 중간제품및 / 또는 API 제조업체는중요물품공급업체의평가시스템을구비해야한다 Materials should be purchased against an agreed specification, from a supplier or suppliers approved by the quality unit(s). 품질조직 (QU) 에서승인한공급업체로부터합의된규격에따라물품을구입한다 If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer. 중요물품공급업체가그물품의제조업체가아닌경우에는실제제조업체의명칭과주소를중간제품및 / 또는 API 제조업체가파악하고있어야한다 Changing the source of supply of critical raw materials should be treated according to Section 13, Change Control. 중요원료공급원의변경은 13 항의변경관리절차에따라처리한다. 7.2 인수와격리보관 (Receipt and Quarantine) 7.20 Upon receipt and before acceptance, each container or grouping of containers of materials should be examined visually for correct labelling (including correlation between the name used by the supplier and the inhouse name, if these are different), container damage, broken seals and evidence of tampering or contamination. Materials should be held under quarantine until they have been sampled, examined or tested as appropriate, and released for use. 물품이납품되면이를인수하기전에, 물품컨테이너별로또는컨테이너그룹별로육안검사를실시해라벨링의정확성 ( 공급업체가사용하는명칭과자체명칭이 43

3 다른경우에이의상관관계포함 ), 컨테이너파손, 밀봉손상여부, 임의변경이나 오염의징후를확인한다. 검체를채취하여필요에따라시험또는검사를실시하고 사용승인이나기까지, 해당물품을격리상태로보관한다 Before incoming materials are mixed with existing stocks (e.g., solvents or stocks in silos), they should be identified as correct, tested, if appropriate, and released. Procedures should be available to prevent discharging incoming materials wrongly into the existing stock. 신규물품을기존재고 ( 예, 사일로의용매나재고 ) 와혼합하기전에, 신규물품이정확한지확인하고적절한경우에는시험한다음에사용을승인한다. 신규물품을기존재고와잘못되게혼합하는사태를방지하기위한절차문서를구비한다 If bulk deliveries are made in non-dedicated tankers, there should be assurance of no cross-contamination from the tanker. Means of providing this assurance could include one or more of the following: 비전용탱크에담은상태로벌크를납품받는경우, 탱크에의한교차오염이없도록해야한다. 이를위한방법으로다음사항을하나이상갖춘다. - certificate of cleaning 세척증명서 - testing for trace impurities 미량불순물시험 - audit of the supplier. 공급업체감사 7.23 Large storage containers, and their attendant manifolds, filling and discharge lines should be appropriately identified. 큰저장컨테이너와이에부속된매니폴드, 충진및토출라인을적절하게식별표시한다 Each container or grouping of containers (batches) of materials should be assigned and identified with a distinctive code, batch, or receipt number. This number should be used in recording the disposition of each batch. A system should be in place to identify the status of each batch. 각물품컨테이너또는컨테이너 ( 배치 ) 그룹별로고유코드, 배치또는인수번호를 44

4 부여하고표시한다. 각배치의처리기록에이번호를사용한다. 각배치의상태를 표시하는시스템을구비한다. 7.3 신규생산물품의검체채취와시험 (Sampling and Testing of Incoming Production Materials) 7.30 At least one test to verify the identity of each batch of material should be conducted, with the exception of the materials described below in A supplier's Certificate of Analysis can be used in place of performing other tests, provided that the manufacturer has a system in place to evaluate suppliers. 7.32항에기술된물품을제외하고, 물품배치별로최소 1개의확인시험을실시한다. 다른시험항목은공급업체의성적서 (Certificate of Analysis) 로대체할수있다. 다만공급업체평가시스템을구비해야한다 Supplier approval should include an evaluation that provides adequate evidence (e.g., past quality history) that the manufacturer can consistently provide material meeting specifications. Full analyses should be conducted on at least three batches before reducing in-house testing. However, as a minimum, a full analysis should be performed at appropriate intervals and compared with the Certificates of Analysis. Reliability of Certificates of Analysis should be checked at regular intervals. 공급업체승인을위해서는평가를실시하여그제조업체가규격에부합하는물품을일관되게공급할수있다는적절한증거 ( 예, 과거품질내역 ) 를확보할필요가있다. 자체시험을축소하기전에최소 3개배치에대해모든분석을실시한다. 그러나최소한적절한주기로모든분석항목을시험하여 COA와비교한다. COA의신뢰성을주기적으로점검한다 Processing aids, hazardous or highly toxic raw materials, other special materials, or materials transferred to another unit within the company s control do not need to be tested if the manufacturer s Certificate of Analysis is obtained, showing that these raw materials conform to established specifications. Visual examination of containers, labels, and recording of batch numbers should help in establishing the identity of these materials. The lack of on-site testing for these materials should be justified and documented. 45

5 공정보조물, 유해원료또는고독성원료, 기타특수물품또는회사의관리범위이내에서다른부서로이전되는물품은시험할필요가없다. 다만이들원료가설정규격에부합함을보여주는제조업체의 COA를확보해야한다. 용기의육안검사, 라벨, 배치번호기록이이들물품의확인에도움이된다. 제조소에서이들물품을시험하지않는다면, 이에대한타당성을증명하고문서화한다 Samples should be representative of the batch of material from which they are taken. Sampling methods should specify the number of containers to be sampled, which part of the container to sample, and the amount of material to be taken from each container. The number of containers to sample and the sample size should be based upon a sampling plan that takes into consideration the criticality of the material, material variability, past quality history of the supplier, and the quantity needed for analysis. 검체는검체가채취된해당물품배치를대표할수있어야한다. 검체채취대상컨테이너의수, 컨테이너가운데검체채취부위, 컨테이너별검체채취량이규정된검체채취방법을구비한다. 물품의중요성, 물품변동성, 공급업체의과거품질이력, 분석에필요한양을고려해검체채취계획을수립하고이를토대로검체채취대상컨테이너의수와검체량을결정한다 Sampling should be conducted at defined locations and by procedures designed to prevent contamination of the material sampled and contamination of other materials. 지정장소에서검체채취대상물품의오염과다른물품의오염을방지할수있는방법으로검체를채취한다 Containers from which samples are withdrawn should be opened carefully and subsequently reclosed. They should be marked to indicate that a sample has been taken. 검체채취대상컨테이너를조심스럽게개봉하고다시밀봉한다. 검체가채취되었음을컨테이너에표시한다. 7.4 보관 (Storage) 7.40 Materials should be handled and stored in a manner to prevent degradation, contamination, and cross-contamination. 46

6 분해, 오염, 교차오염을방지할수있는방식으로물품을취급하고보관한다 Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate, suitably spaced to permit cleaning and inspection. 파이버드럼, 백, 박스에보관된물품을바닥에서공간을띄워보관하며, 적절한경우에는세척과검사가가능하게적절한공간을두어관리한다 Materials should be stored under conditions and for a period that have no adverse affect on their quality, and should normally be controlled so that the oldest stock is used first. 품질에부정적영향을주지않는조건과기간동안물품을보관하며, 가장오래된재고를가장먼저사용할수있도록관리한다 Certain materials in suitable containers can be stored outdoors, provided identifying labels remain legible and containers are appropriately cleaned before opening and use. 적합한컨테이너에담은일부물품을야외에보관할수도있다. 다만식별표시라벨의판독성이유지되어야하고컨테이너를개봉하여사용하기전에적절하게세척한다 Rejected materials should be identified and controlled under a quarantine system designed to prevent their unauthorised use in manufacturing. 부적합물품은그상태를표시하고허가없이제조에사용되지않게격리상태로관리한다. 7.5 재평가 (Re-evaluation) 7.50 Materials should be re-evaluated as appropriate to determine their suitability for use (e.g., after prolonged storage or exposure to heat or humidity). 물품이사용에적합한지결정하기위해물품을적절하게재평가한다 ( 예, 장기보관이후또는열이나습기에노출된이후 ). 8. 생산및공정관리 (PRODUCTION AND IN-PROCESS CONTROLS) 8.1 생산작업 (Production Operations) 47

Microsoft Word - ICH Q7 API GMP Guide

Microsoft Word - ICH Q7 API GMP Guide 분해, 오염, 교차오염을방지할수있는방식으로물품을취급하고보관한다. 7.41 Materials stored in fiber drums, bags, or boxes should be stored off the floor and, when appropriate, suitably spaced to permit cleaning and inspection. 파이버드럼,