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产品研发

product research and development

    广州西典医药科技有限公司
    电话:0769-2223 5501
    地址:广东省东莞市松山湖高新技术产业开发区阿里山路19号产业化中心8栋4楼

    东莞西典医药科技有限公司
    电话:0769-2223 5501
    地址:广东省东莞市松山湖高新技术产业开发区阿里山路19号产业化中心8栋4楼

    江苏西典药用辅料有限公司
    电话:0523-80103166
    地址:江苏省泰州市海陵区中国医药城四期标准厂房G56幢一至四层西侧

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产品技术转移


产品技术转移是GMP认证检查的核心内容,也是产品研发和产品报批的关键内容。


技术转移作为产品从科研向产业化过度的关键步骤,需要按照产品技术的本身要求,密切与生产条件相结合,

同时也需要符合相关的法规规范要求。产品技术转移项目,需要用科学合理的方法,以及按照规范的程序进行。


• 产品技术转移方案;

• 风险管理;

• 处方和工艺;

• 原材料及供应商;

• 质量标准:原辅料、包装材料、中间产品、成品;

• 分析方法验证

• 变更控制;

• 清洁验证;

• 工艺验证;

• 稳定性试验;

• 临床/生物等效性研究;

• 产品技术转移报告;

• 产品报批。

 

新的制药设施建成后,在进入产品的商业化生产前,首要的任务是产品的技术转移和产品的报批(新的生产

批文的申请或原有生产批文的变更补充申请)。

产品技术转移需要遵循相关的法规规范,达到产品质量一致性的要求,并完成相应的产品审批。

产品技术转移项目,需要用科学合理的方法,以及按照规范的程序进行。

 

Oral Solid Dosage Form Development

 

Stage

 

 

Firms Responsibility

 

GMP Consulting

 

I

 

Establish an oral solid dosage form manufacturing facility with acceptable CGMP compliance

 

A) Conduct a system-based auditing

1) Quality System

2) Materials System

3) Facilities and Equipment System

4) Production System

5) Packaging and Labeling System

6) Laboratory Control System

 

B) Provide an auditing report to identify deficiencies and to recommend corrective actions.

 

C) Provide necessary CGMP trainings based on the deficiencies identified.

 

 

II

 

A) Conducting suitability studies on

· API

· Key excipients

· Formulation

· Product specification

· Product package

· Product stability

 

B) Development of manufacturing process

 

C) Manufacture of one pilot batch for stability and BE studies

 

A) Provide CGMP consulting related to pre- formulation studies

· Pre-formulation report to provide data to support the product formulation and process design

 

B) Provide CGMP consulting on process design and development, which include:

· Product characterization and qualification studies

· Process design and process optimization

· Critical parameters and in-process controls

· Analytical method development

· Product development report.

 

 

III

 

Preparation and conducting formal process validation

(three conforming batches at commercial scale)

 

A) Provide consult service on formal process validation (three conforming batches) to establish process reproducibility and consistency

 

The following process documentations should be established:

· Formulation development report

· Process feasibility report

· Product development report

 

Validation Master Plan (Protocol and final report)

a) DQ/IQ/OQ/PQ

b) Cleaning validation

c) Analytical methods validation

d) Formal process validation

e) Out of specifications

 f) Change controls

g) Product stability report

 

B) The test used to demonstrate process reproducibility and consistency among validation (or conforming) batches should be:

· Particle or granule size distribution

· Bulk density

· Moisture content

· Hardness

· Thickness

· Friability

· Weight uniformity

· Potent uniformity

· Disintegration/dissolution profile

 

 

IV

 

Bioequivalence study (BE) conducted through CRO

 

 

Monitoring BE study from CGMP perspective

 

V

 

Provide related CMC information for preparation ANDA application

 

ANDA application preparation

· Drug substance section (DMF)

· Bioequivalence study section

· Drug product section

· Others