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                        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

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                        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




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