发布时间 : 星期六 文章annual review 产品质量年度回顾英文版模板更新完毕开始阅读480052859a89680203d8ce2f0066f5335a8167aa
XXXXXXXXXXXXX
Quality SOP
Annual Reviews
SOP No.: M-050 Effective: Supersedes: 11/8/01 Page 1 of 2 DBC: 6.17
1.0
PURPOSE:
To perform the annual review of complaints, recalls, returned or salvaged drug products,
notification of rejection forms, out of specification result forms, critical system change control forms, investigation/deviation report forms, product specifications, manufacturing and control procedures.
SCOPE: 2.1
All Customer complaints, recalls, returned or salvaged drug products, notification of
rejection forms, out of specification result forms, critical system change control forms, investigation/deviation reports that occurred throughout the year will be reviewed on an annual basis.
Applies to all products and the documents pertaining to their manufacture.
2.0
2.2
3.0
RESPONSIBILITY:
3.1 It is the responsibility of the Quality Control/Stability Systems Technician to prepare a
separate annual report on each product that is marketed by Company.
3.2 The Quality Assurance Assistant Scientist and/or the QA Manager is responsible for
reviewing the documentation from selected batches of every product.
3.3
3.4 3.5
3.6
The QA/QC Director and/or the QA Manager and/or QC Manager are responsible for: 3.3.1 Reviewing each products annual report.
3.3.2 Perform review of recalls, returned or salvaged drug products, notification of
rejection forms, out of specification result forms, critical system change control forms, investigation/deviation report forms.
The Regulatory Affairs Paralegal is responsible for providing a summary annual review report of all complaints by product.
The Regulatory Affairs Director is responsible for reviewing the summary annual complaint report.
The QA/QC Director is responsible for notifying the responsible officials of the company in writing if an investigation is performed on Returned Drug products or on Drug Products that are salvaged because of improper storage conditions.
Principal Author
Approver/Date
Approver/Date
Approver/Date
XXXXXXXX
Quality SOP
DBC: 6.17
Annual Reviews
SOP No.: M-050 Effective: Supersedes: 11/8/01 Page 2 of 2 4.0
PROCEDURE: 4.1
The records associated with a selected batch/lot of finished product for each bulk formula, including all raw material and packaging material records that are used to manufacture and package the batch/lot of product are reviewed for content and completeness annually. The records for complaints, recalls, returned or salvaged drug products, notification of rejection forms, out of specification result forms, critical system change control forms and investigation/deviation reports are reviewed. The annual review file contains the QC review results summarized by product, QA results summarized for each bulk formulation, and the Regulatory Affairs results summarized by product. 4.2.1
The Regulatory Affairs Paralegal will log all complaints for each product on a list, indicating the type of complaint, it’s frequency and any trends noted. This list is reviewed by the Regulatory Affairs Director to determine any significant changes in frequency or type of complaint for each product from previous years.
The causes for any recalls will be examined and an investigation will be performed to assure all corrections were made to the reason for the recall. The report of the investigation is issued to the responsible officials of the company.
The returned goods policy is reviewed for content and implementation. The returned goods reports are reviewed to assure completeness and accuracy. Any necessary changes will be made as required. If an investigation is required, the responsible officials of the company will be notified.
Notification of Rejection Forms are reviewed and summarized for trends. Critical System Change Control forms are reviewed for completeness.
Out of Specification Result Forms are reviewed and summarized for trends. Investigation/Deviation Reports are reviewed to determine any trends. Recommendations for improvement in an area will be given to the correct department manager.
4.2
4.2.2 4.2.3
4.2.4 4.2.5 4.2.6 4.2.7
4.3
4.4
Each product’s annual report, which contains the following, is reviewed:
4.3.1 Stability Assay test results are recorded for each product on a yearly basis. The
data is reviewed throughout the shelf life of the product. If a product has no expiration date then results are recorded for at least 48 months and reviewed.
4.3.2 Quality Control test results for each batch are reviewed for each product. The data
are tabulated in an Excel spreadsheet and a summary is generated for each product.
Product specifications, Product Control Procedures, the current Formula and the Manufacturing Procedures are updated as needed based on the annual review.
4.5
The annual review is documented and filed.合同管理制度 1 范围
XXXXXXXX
Quality SOP
DBC: 6.17
Annual Reviews
SOP No.: M-050 Effective: Supersedes: 11/8/01 Page 3 of 2 本标准规定了龙腾公司合同管理工作的管理机构、职责、合同的授权委托、洽谈、承办、会签、订阅、履行和变更、终止及争议处理和合同管理的处罚、奖励； 本标准适用于龙腾公司项目建设期间的各类合同管理工作，厂内各类合同的管理，厂内所属各具法人资格的部门，参照本标准执行。 2 规范性引用 《中华人民共和国合同法》 《龙腾公司合同管理办法》 3 定义、符号、缩无 4 职责 4.1 总经理：龙腾公司经营管理的法定代表人。负责对厂内各类合同管理工作实行统一领导。以法人代表名义或授权委托他人签订各类合法合同，并对电厂负责。 4.2 工程部：是发电厂建设施工安装等工程合同签订管理部门；负责签订管理基建、安装、人工技术的工程合同。 4.3 经营部：是合同签订管理部门，负责管理设备、材料、物资的订购合同。 4.5 合同管理部门履行以下职责： 4.5.1 建立健全合同管理办法并逐步完善规范； 4.5.2 参与合同的洽谈、起草、审查、签约、变更、解除以及合同的签证、公证、调解、诉讼等活动，全程跟踪和检查合同的履行质量； 4.5.3 审查、登记合同对方单位代表资格及单位资质，包括营业执照、经营范围、技术装备、信誉、越区域经营许可等证件及履约能力（必要时要求对方提供担保），检查合同的履行情况； 4.5.4 保管法人代表授权委托书、合同专用章，并按编号归口使用； 4.5.5 建立合同管理台帐，对合同文本资料进行编号统计管理； 4.5.6 组织对法规、制度的学习和贯彻执行，定期向有关领导和部门报告工作； 4.5.7 在总经理领导下，做好合同管理的其他工作， 4.6 工程技术部：专职合同管理员及材料、燃料供应部兼职合同管理员履行以下职责： 4.6.1 在主任领导下，做好本部门负责的各项合同的管理工作，负责保管“法人授权委托书”； 4.6.2 签订合同时，检查对方的有关证件，对合同文本内容依照法规进行检查，检查合同标的数量、金额、日期、地点、质量要求、安全责任、违约责任是否明确，并提出补充及修改意见。重大问题应及时向有关领导报告，提出解决方案； 4.6.3 对专业对口的合同统一编号、登记、建立台帐，分类整理归档。对合同承办部门提供相关法规咨询和日常协作服务工作； 4.6.4 工程技术部专职合同管理员负责收集整理各类合同，建立合同统计台帐，并负责 略语