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ISO 15378:2017
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)- 발행일 : 2017-09-14
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 76 : Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use |
|---|---|
| 적용범위 | ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards. In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. |
| 국제분류(ICS)코드 |
03.100.70 : 관리시스템
11.040.01 : 일반 의료장비 |
| 페이지수 | 79 |
| Edition | 4 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 15378:2017/Amd 1:2024상세보기 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) — Amendment 1: Climate action changes | 2024-02-23 | 표준 |
| 2 | ISO 15378:2017상세보기 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) | 2017-09-14 | 표준 |
| 3 | ISO 15378:2015상세보기 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) | 2015-10-06 | 구판 |
| 4 | ISO 15378:2011상세보기 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) | 2011-10-25 | 구판 |
| 5 | ISO 15378:2006상세보기 | Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP) | 2006-03-01 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ISO 2233:2000 - Packaging — Complete, filled transport packages and unit loads — Conditioning for testing
- ASTM F1886/F1886M-16 - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- ISO 4180:2019 - Packaging — Complete, filled transport packages — General rules for the compilation of performance test schedules
- ASME A17.1-2016/CSA B44-16 - Safety Code for Elevators and Escalators
- ISO 21266-1:2018 - Road vehicles — Compressed gaseous hydrogen (CGH2) and hydrogen/natural gas blends fuel systems — Part 1: Safety requirements
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification
- KS B ISO/TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO/TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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