<span id="bvxjj"></span><span id="bvxjj"></span>
<span id="bvxjj"></span>
<span id="bvxjj"><dl id="bvxjj"><del id="bvxjj"></del></dl></span><strike id="bvxjj"></strike>
<strike id="bvxjj"><i id="bvxjj"></i></strike><strike id="bvxjj"></strike>
中文  |  ENGLISH

Research and development

    Guangzhou Westpoint Pharmatech. Co., Ltd.
    Tel:0769-2223 5501
    Address: 4th Floor, 8th Building, Industrial Center, No. 19 Alishan Road, Songshan Lake High-tech Industrial Development Zone, Dongguan City, Guangdong Province

    Dongguan Westpoint Pharmatech. Co., Ltd.
    Tel:0769-2223 5501
    Address: 4th Floor, 8th Building, Industrial Center, No. 19 Alishan Road, Songshan Lake High-tech Industrial Development Zone, Dongguan City, Guangdong Province

    Jiangsu Westpoint Pharmaceutical Excipients Co., Ltd.
    Tel:0523-80103166
    Address: West side of 1st to 4th floor of G56 Standard Factory Building of China Pharmaceutical City Phase IV, Hailing District, Taizhou City, Jiangsu Province

Your location:Home >

Product technology transfer

Product technology transfer is the core of GMP inspection and certification. It is also the pivotal of drug development and regulatory approval.

As the important step of the transition from laboratory research to commercial production, technology transfer should be closely accord with production conditions and the requirements of product technology itself. It should also meet the relevant regulations and requirements. Product technology transfer should be based on scientific and practical manner and follow the standard operation procedures.



Product technology transfer program;

Risk management;

Formulation and technology;

Raw materials and suppliers;

Specifications: raw materials, packaging materials, intermediate and finished products;

Analytical method validation;

Change control;

Cleaning validation;

Process validation;

Stability test;

Clinical/bioequivalence studies;

Product technology transfer protocol;

Document for product approval application.


After the completion of a new pharmaceutical facility, the primary task before commercial drug production is the technology transfer of the product and the document preparation for product approval (new product application or post-approval application for an approved drug product).

 

Technology transfer for a drug product should comply with related regulations, totally meet the drug product specifications and are ready to prepare the document for drug product approval.


Oral Solid Dosage Form Development

 

Stage

 

 

Firm’s Responsibility

 

GMP Consulting Responsibility

 

I

 

Establish a manufacturing facility for oral solid dosage form in compliance with cGMP regulation

 

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 making corrections.

 

C) Provide necessary cGMP training based on the identified deficiencies.

 

 

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 consult related to pre-formulation studies

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

B) Provide cGMP consult on process design and development, which include:

· Product characterization and             qualification studies

· Process design and optimization

· Critical parameters and in-process controls

· Analytical method development

· Product development report.

 

 

III

 

Preparation and conducting formal process validation

(three confirming batches at commercial scale)

 

A) Provide consult service on process validation (three confirming batches) to establish process repeatibility 

 

The following process documentation should be established:

· Formulation development report

· Process feasibility 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 tests used to demonstrate process repeatability. Validation batches should concern:

·Particle or granule size distribution

· Bulk density

· Moisture content

· Hardness

· Thickness

· Friability

· Weight uniformity

· Content uniformity

·  Disintegration/dissolution profile

 

 

IV

 

Bioequivalence study (BE)

conducted through CRO

 

 

Monitoring BE study from cGMP requirement

 

V

 

Provide related CMC information for ANDA application

 

ANDA application

· Drug substance section (DMF)

· Drug product section

· Bioequivalence study section

· Others




美女撒尿TXXXX视频_美女撒尿全过程高清视频_美女视频黄的免费看网站_主页