Microsoft Word - part820preamblesubpart l handling storage distribution and installation.doc

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1 L. 취급, 보관, 유통, 설치 (Handling, Storage, Distribution, and Installation) (Subpart L) i. 취급 (Handling)(Sec ) 173. One comment on proposed Sec Handling suggested that the procedures be "designed to prevent," rather than be established to "ensure that," problems delineated in the section do not occur. The comment stated that the word "prevent" would add clarity, without compromising the meaning of the sentence. Another comment stated that the handling procedures should apply "prior to distribution," not during "any stage of handling." One comment stated that the requirement does not cover the need for special precautions in handling used devices which may be contaminated, and that this is an important issue covered by ISO/CD " 취급 " 과관련하여, 이섹션에제시된문제들이발생하지않도록 " 보장 " 하기위해서보다는, " 예방하도록 " 절차를설계해야한다는의견이한건있었다. " 예방 " 이란단어는이문장의의미를훼손하지않으면서명확성을더해줄것이라고주장했다. 또한취급절차는 " 취급단계 " 동안이아니라, " 유통이전 " 에적용되어야한다는의견도있었다. 이외에도이기준은오염가능성이있는, 사용되었던의료용구취급시의특별주의사항필요성을다루고있지않으며, 이부분은 ISO/CD 13485에서중요한이슈로다루고있는것이라는의견이한건있었다. FDA does not believe that Sec , now Sec , as written is unclear. The procedures are expected to ensure that mixups, damage, deterioration, contamination, or other adverse effects do not occur. FDA amended the requirement, however, to remove "any stage of" so it reads "during handling." The requirement continues to apply to all stages of handling in which a manufacturer is involved, which may in some cases go beyond initial distribution ( 현재의 ) 은명확하지않다고생각하지않는다. 절차는혼입, 훼손, 품질저하, 오염, 기타부정적영향이발생하지않도록해야한다. 하지만 "-의모든단계 " 를삭제하고 " 취급시에 " 로수정했다. 이기준은제조업체가관여하는모든취급단계에계속적용되며, 경우에따라서는최초유통이상까지이어질수있다. The comparable provision in ISO/CD states, "If appropriate, special 1

2 provisions shall be established, documented and maintained for the handling of used product in order to prevent contamination of other product, the manufacturing environment and personnel." FDA agrees with this requirement and has therefore added the term "contamination" to Secs Handling and Storage. ISO/CD 13485의이에상응하는조항은 " 다른제품, 제조환경, 작업자의오염예방을위하여, 적절한경우에사용했던제품의취급을위한특별조치를확립하고문서화하고유지해야한다 " 고규정하고있다. FDA는이기준에동의하며, 그에따라 " 취급 " 과 820/150 " 보관 " 에 " 오염 " 을추가했다. ii. 보관 (Storage)(Sec ) 174. Two comments stated that proposed Sec Storage should be amended to be similar to ISO 9001, and that the rest of the requirements should be deleted and included in a guidance document. One comment stated that the term "obsolete" should be deleted because, although a device may no longer be sold, thereby making it obsolete, the components for that device may still be stored for customer support of the existing devices " 보관 " 을 ISO 9001과유사하게수정해야하며, 나머지기준은삭제하고가이드라인문서에포함시켜야한다는의견이두건있었다. 또한 " 구형 " 이란표현을삭제해야한다는의견이있었는데, 어떤의료용구가더이상판매되지않아구형이되더라도, 그의료용구의컴포넌트는기존의료용구의고객지원을위해보관할수도있다는이유때문이었다. FDA agrees that Sec , now Sec , could be more consistent with ISO 9001 and has revised the section to harmonize with ISO 9001:1994. FDA has not deleted the term "obsolete." FDA understands that a device may no longer be sold, but that parts and subassemblies may still be required for customer support; therefore, those components or subassemblies are not "obsolete." FDA's intent in this requirement is to ensure that only the appropriate product be used or distributed ( 현재의 ) 이 ISO 9001과유사하게만들수있다는점에동의하여, ISO 9001:1994와조화되도록수정했다. " 구형 " 이란표현은삭제하지않았다. 의료용구가더이상판매되지않더라도부품과서브어셈블리는고객지원을위해여전히필요할수있다는점을이해한다. 그러므로그런컴포넌트나서브어셈블리는 " 구형 " 이아니다. 이 2

3 기준에서추구하는 FDA 의의도는, 적절한제품만이사용되거나출하되도록하는데있다. FDA has deleted the requirement that control numbers or identifications be legible and visible because it believes the requirement is inherent in Sec (a), which requires the manufacturer to establish procedures to prevent mixups. To do this, a manufacturer must ensure that product can be properly identified. 관리번호또는식별표시가판독성과가시성을갖추어야한다는기준은삭제했다. 혼입방지절차를확립해야한다는 (a) 에이기준이내재되어있다고봤기때문이다. 이를위해제조업체는제품이적절하게식별되도록해야한다 A comment stated that restricting access to designated areas through the use of keys, bar code readers, or other means, should be sufficient to meet the intent of the requirement in proposed Sec (b), without the need for written procedures for authorizing receipt. 열쇠, 바코드판독기, 또는기타수단으로지정지역접근을제한하면, 접수승인절차문서가없어도 (b) 기준의의도를충족시키는데충분하다는의견이있었다. FDA has not deleted the requirement for procedures, now in Sec (b), to authorize receipt of product because the agency believes that strict control over product in storage areas and stock rooms results in decreased distribution of nonconforming product. Thus, even where locked storage rooms are utilized, the procedures should detail, among other things, who is permitted access and what steps should be followed prior to removal. 보관지역및창고의제품에대한엄격한관리가부적합제품의유통감소로이어질수있다고믿기때문에, 제품입고승인절차를갖추도록한이기준 ( 현재의 (b)) 을삭제하지않았다. 그러므로시건장치를갖춘보관실을활용하더라도, 무엇보다도접근이허용된자와물품반출에앞서따라야할단계를상세히기술한절차가있어야한다. iii. 출하 (Distribution)(Sec ) 176. A few comments on proposed Sec Distribution stated that there are times when "first in, first out" inventory procedures may not be in the best interest of the customer. The comments said that especially when expiration dating is defined and labeled, a "first in, first out" system should not be required. The GHTF and other EU comments stated that if a new section "Contract review," similar to 3

4 ISO 9001:1994, section 4.3 was not added to the regulation, the requirement that "purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution" should be added to this section " 출하 " 와관련하여, " 선입선출 " 절차가고객의이익에도움이되지않는경우도있다는의견이일부있었다. 특히유효일자가지정되고라벨에명시되어있을때, " 선입선출 " 시스템은필요하지않다고주장했다. GHTF와 EU는, ISO 9001:1994 섹션 4.3과유사한 " 계약검토 " 섹션을이규정에추가하지않는다면, " 의료용구의출하승인에앞서모호성과오류를해결하기위해구매주문서를검토해야한다 " 는기준을이섹션에추가해야한다고주장했다. FDA agrees with the comments. FDA has amended the requirement in Sec to state that the procedures must ensure that "expired devices or devices deteriorated beyond acceptable fitness for use" are not distributed. FDA has also added the sentence on reviewing purchase orders. 이들의견에동의한다. " 유효기간이지난의료용구나허용용도적합성을벗어나는수준으로품질이저하된의료용구 " 는출하할수없도록 의기준을수정했다. 또한구매주문서의검토에관한문장을추가했다 A few comments on proposed Sec (b) stated that class I devices should be exempt, or that the requirement should apply only to critical devices, because all devices do not require control numbers. Other comments stated that the term "consignee" should be defined, or the word "primary" should be added before "consignee" for clarity (b) 와관련하여클래스 I 의료용구는면제대상으로하거나이기준을핵심의료용구에만적용해야한다는의견이일부있었다. 모든의료용구에관리번호가필요하지않다는것이다. 또한 " 인수자 " 의의미를정의하거나, 의미를명확히하기위하여 " 인수자 " 앞에 " 일차 " 를추가해야한다는의견이있었다. FDA agrees in part with the comments and in Sec (b) has added the term "initial" before "consignee" to make clear that the requirement for maintaining distribution records extends to the first consignee. FDA has retained the word "consignee" and notes that it is a person to whom the goods are delivered. FDA has also clarified Sec (b)(4) by requiring "Any control number(s) used." Therefore, if the manufacturer is required by Sec to have control numbers, 4

5 these must be recorded along with any control numbers voluntarily used. Logically, control numbers are used for traceability so they should be recorded in the DHR distribution records. FDA disagrees, however, that the requirement to maintain distribution records should not apply to class I devices. The information required by this section is basic information needed for any class of product in order to conduct recalls or other corrective actions when necessary. 이들의견에부분적으로동의하여, 출하기록서의유지기준이최초인수자까지확대됨을명확히하기위해, " 인수자 " 앞에 " 최초 " 를추가했다. " 인수자 " 란표현은그대로유지했으며, 인수자는상품이전달된사람을의미한다. 또한 " 사용된관리번호 " 를요구함으로써, (b)(4) 의의미를명확히했다. 그러므로 에따라제조업체가관리번호를부여한다면, 자발적으로사용한관리번호와함께이정보를기록해야한다. 관리번호는추적관리에사용되므로, 그정보를 DHR 출하기록서에기록해야한다. 하지만출하기록서유지기준을클래스 I 의료용구에적용해서는안된다는의견에는동의하지않는다. 이섹션이요구하는정보는, 필요할때리콜또는기타시정조치를취하기위하여모든클래스의제품에필요한기본정보이다. iv. 설치 (Installation)(Sec ) 178. Several comments received on proposed Sec , Installation stated that not all devices require installation. Several comments on the Working Draft asked that, "The results of the installation inspection shall be made available to FDA upon request" be deleted because this was redundant with FDA's access to these documents under Sec " 설치 " 와관련하여, 모든의료용구가설치를필요로하는것은아니라는의견이다수있었다. 또한 " 설치검사의결과를요청시에 FDA에제공해야한다 " 는 에의거한 FDA의이들문서접근과중복되기때문에삭제해야한다는의견도많았다. FDA agrees with the first set of comments. As discussed in Sec , the installation requirements only apply to devices that are capable of being installed. However, to further clarify the requirements in Sec , FDA has made clear that the requirement applies to "devices requiring installation." FDA also agrees that the sentence on document availability is redundant with Sec for all records and has deleted the sentence. 첫번째의견에동의한다 에서설명한바와같이, 설치기준은설치가가능한 5

6 의료용구에만적용된다. 그러나 의기준을보다명확히하기위하여, 이기준이 " 설치를필요로하는의료용구 " 에적용된다는점을분명히했다. 또한문서접근성관련 문장이 의기록서기준과중복된다는지적에동의하며, 이문장을삭제했다 Several comments raised the issue of applying the regulation requirements to third party installers. 이기준을제 3 자설치업체에적용하는문제와관련하여많은의견이접수되었다. FDA has rewritten Sec Persons who install medical devices have been regulated under the original CGMP under Sec (k) which describes a manufacturer as one who "assembles or processes a finished medical device," and continue to be regulated under this quality system regulation under Sec (o). Section Installation of the original CGMP discussed the manufacturer or its authorized representative and persons other than the manufacturer's representative. This regulation eliminates that terminology. Under the revised requirement in Sec (a), the manufacturer establishes installation and inspection instructions, and where appropriate test procedures. The manufacturer distributes the instructions and procedures with the device or makes them available to person(s) installing the device. Section (b) requires that the person(s) installing the device follow the instructions and procedures described in Sec (a) and document the activities described in the procedures and instructions to demonstrate proper installation 을다시작성했다. 의료용구를설치하는자는최초 CGMP의 820.3(k) 에의거하여규제를받았다. 이조항은제조업체를 " 최종의료용구를조립또는가공 " 하는자로규정하고있다. 또한의료용구를설치하는자는 820.3(o) 에의거하여이품질시스템규정의대상으로계속규제된다. 최초 CGMP의섹션 " 설치 " 는제조업체또는그의공인대표자및제조업체대표자이외의다른자에대해거론했다. 이규정은그런표현을배제한다. 수정된 (a) 에의거하여, 제조업체는설치및검사지시사항, 그리고적절한경우에는시험절차를확립한다. 제조업체는의료용구와함께그지시사항및절차를배포하거나그의료용구를설치하는자가활용할수있게한다. 섹션 (b) 는의료용구를설치하는자가 (a) 에기술된지시와절차를따르고, 그절차및지시에기술된활동사항을기록하여설치가적절하게이루어졌음을증명해야한다고요구하고있다. 6

7 The revised provisions in Sec (b) explicitly require that the installation be performed according to the manufacturer's instructions, regardless of whether the installer is employed by or otherwise affiliated with the manufacturer. Section (b) requires records to be kept by whomever performs the installation to establish that the installation was performed according to the procedures. Such records will be available for FDA inspection. FDA does not expect the manufacturer of the finished device to maintain records of installation performed by those installers not affiliated with the manufacturer, but does expect the third party installer or the user of the device to maintain such records. 수정된 (b) 는, 설치자가제조업체의고용인이거나계열관계에있건, 제조업체의지시에따라설치를수행해야한다고명확히요구한다. 섹션 (b) 는설치를수행한자가기록서를유지하여설치가절차에따라수행되었음을보여주어야한다고요구한다. 그리고그기록서는 FDA 실사대상이다. 최종의료용구제조업체와계열관계에있지않은설치업체에의해수행된설치에관한기록서를최종의료용구제조업체가유지하고있으리라기대하지않지만, 제 3자설치업체또는의료용구사용자는그런기록서를유지해야할것이다. FDA believes that making these requirements explicit in the regulation is necessary to ensure that devices are safe and effective, and that they perform as intended after installation. FDA notes again that installers are considered to be manufacturers under the original CGMP regulation and that their records are, and will continue to be, subject to FDA inspections when the agency deems it necessary to review such records. 이런기준을규정에명확히해두는것이의료용구의안전성과유효성확보와설치이후의료용구의올바른기능에필요하다고믿는다. 최초 CGMP 규정에따르면설치업체도제조업체로간주되고, FDA가이들업체의기록서를검토할필요가있다고판단하면, 이들업체의기록서는 FDA 실사대상이되며, 앞으로도그럴것이다. 7

Microsoft Word - part820preamblesubpart D document controls.doc

Microsoft Word - part820preamblesubpart D document controls.doc D. 문서관리 (Document Controls)(Subpart D) 93. One comment stated that subpart D of part 820 should be titled "Document Controls," instead of the proposed "Document and Record Controls" because the "record"