New Services

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EPMC/CQV GMP

URS(DD)

URS through DETAILED DESIGN (DD) & Build (via strategic partner)

FULL ENGINEERING CAPABILITIES:

1) EXECUTION & SUPPORT

2) COMPLIANCE & OPTIMIZATION

3) Drawings, Elevations, Master Plans

4) Process Flows

5) Utilities – HVAC, CS, WFI, PW, Process Gasses, …

6) Commissioning & GMP Validation -- Plans, Execution, Gap Analysis


 

工程管理无缝衔GMP验证 管理

URS贯穿于整个详细设计

(DD)以及建设过程(采用战略合作伙伴)

完整的工程能力: 

1) 执行及支持

2) 合规及优化

3) 图纸、立面图、主计划 

4) 工艺流程

5) 通用工程 – 空调系统、纯蒸汽、注射用水、纯水、工艺气体   

6) 试运行及GMP验证 – 计划、执行、差距分析

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Global GMP compliant method validation and testing: Suite of tests for large molecule therapeutics (including cell and gene therapies), as well as GMP operational (water system, cleaning validation) related methods available for your product development and manufacturing needs.


Including microbiology, cell biology, physical-chemical, qPCR methods, both Compendium and non-Compendium. Services include method transfer, method validation, OOS investigational support, MCB/WCB release testing etc.


GMP方法验证和检测:全套生物大分子(包括细胞基因治疗)产品和GMP运营(水系统,清洁验证)相关的方法和检测,可满足全球GMP要求。

包括微生物,细胞,普通理化,qPCR等药典及非药典方法。方法转移,验证,OOS调查辅助,整体MCB/WCB检测等等。

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Jade Biomedical is the world’s first CQO which provides comprehensive quality and compliance technical and regulatory services for biopharmaceutical companies throughout the entire product life cycle. Jade’s services meet GMP standards for the global market, which includes US, EU and China and PICS etc., and reflect current industry practices.

 
 

Jade’s CQO services includes, but not limited to:

1) Quality Management System (QMS) design, build, and quality plans, QMS gap analysis and remediation

2) Vendor qualification and quality management including that of CDMOs

3) Process control and product quality control strategy from clinical phases to commercial phase, including product specifications, stability studies etc.

4) dDta integrity management

5) IND submission for US, EU and China

6) QbD strategy and execution

7) Technology Transfer

8) Material management

9) Extractable/leachable studies

10) Cleaning validation, process verification, continuous monitoring programs

11) Act as QA for client company in quality risk assessment, deviation, lot release etc.

12) Comparability studies

13) Regulatory inspection preparations

14) CMC chapters for BLA etc.

 
 

驾玉的质量管理承包业务为客户在药品开发到商业化运营全生命周期的GMP质量管理需求提供量体裁衣式的技术服务。驾玉提供的GMP服务满足国际任何一个区域包括美国,欧盟和中国的现行法规和指南,并符合最先进的行业标准。

 
 

这些服务包括 

1)质量体系和质量年度计划的建立,体系查漏提升

2)供应商包括CDMO质量管理

3)产品临床早期到上市的工艺控制和产品质量控制策略包括质量标准和稳定性方案等

4)数据完整性指导

5)欧美中IND申报

6)QbD方案制定和执行

7)技术转移质量管理

8)原材料,辅料,包材质量管理

9)溶析出物研究

10)清洁验证,工艺验证

11)客户公司QA职责的代执行包括质量风险评估

12)变更可比性研究

13)药监机构GMP审计准备

14)BLA中CMC章节支持等等。

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VALIDATED (passive) COLD CHAIN SOLUTIONS capable of maintaining Drug Substance (DS); Drug Product (DP); Cell Products, and other Laboratory & Clinical Samples and other materials ACROSS ALL ENVIRONEMENTAL CONDITIONS for EXTENDED & ROUTINE periods, using ENVIRONMENTALLY FRIENDLY (GREEN) materials.


冷链运输储藏解决方案加验证(非持续制冷):采用环保材料,用以维持原料药(DS)、制剂(DP)、细胞产品,实验室及临床样本等等医药产品在常规条件下和所有其它环境条件下的运输能力。