QA-002-10上海惠氏.docVIP

PURPOSE 目的 The purpose of this Standard Operating Procedure (SOP) is to provide the standard format for GMP related documents and SWNCL system documentations. 本标准操作规程为GMP相关文件和公司体系文件提供标准化的结构和格式。 SCOPE 范围 This procedure applies to all System Manual and Level III documents (Including related electronic documents in H: \SWNCL_SYSTEM and in H:\SWNCL_SOP and in H:\SWNCL_FormLabel ) including, but not limited to, 本规程适用于所有体系文件及Level III 文件（包括其相应的在H: \SWNCL_SYSTEM, H:\SWNCL_SOP H:\SWNCL_FormLabel中的电子文件）,包括但不限于下列文件： ISO9001Quality Manuals Procedure Documents ISO9001质量手册及程序文件 Food Safety Management Manual 和Supportive Safe Measures(SSM) 食品安全管理手册和安全支持性措施 ISO14001 and OHSAS18001 system Manual Procedure Documents ISO14001和OHSAS18001环境、职业健康和安全体系手册和程序文件 Standard Operating Procedure ，Forms, Attachments, Labels, Product Testing Standard, Purchase Specification of packaging material. 标准操作规程，质量记录表格，附件，标示，产品测试标准，包装材料采购标准 RELATED DOCUMENTS 相关文件 QA-007 Documentation Management 文件管理规程 QA-076 Form/Label Management 表格/标签管理规程 RESPONSIBILITY 职责 All SWNCL employees must follow the standard format in attachment when draft/revise the GMP related document. The divisions in SWNCL are required to comply with the rule as coding the relevant quality system documents. 所有SWNCL员工必须按照附件中的标准格式起草和修改与GMP相关的文件。各部门在编写体系文件时需遵守此SOP中的有关规定。 Definition 定义 1. Purpose: 目的: Identifies intent of the document. 明确建立文件的目的和意图。 2. Scope: 范围: Presents the applicable business types that must comply. 列出该文件适用的业务范围。 3. Responsibility: 职责: Presents the responsible departments or person of the current procedure. 列出当前程序的归口负责部门。 4. Procedure: 程序: Presents how to fufill requirements. 逐一列出达到某一目标要求的各个具体步骤。 5. Related Documents: 相关文件: Presents all the documents related to the current procedure. 列出所有与当前程序相关的文件。 6. References: 参考: Presents all the documents referred to create/revise the current SOP. 列出编写或改写当前标准操作规程时参阅的文件/资料。 7. Attachments: 附件: Lists all of the doc