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          中文  |  ENGLISH

          產品研發

          product research and development

            廣州西典醫藥科技有限公司
            電話:0769-2223 5501
            地址:廣東省東莞市松山湖高新技術產業開發區阿里山路19號產業化中心8棟4樓

            東莞西典醫藥科技有限公司
            電話:0769-2223 5501
            地址:廣東省東莞市松山湖高新技術產業開發區阿里山路19號產業化中心8棟4樓

            江蘇西典藥用輔料有限公司
            電話:0523-80103166
            地址:江蘇省泰州市海陵區中國醫藥城四期標準廠房G56幢一至四層西側

            南京西典藥用輔料有限公司
            電話:13851889093
            地址:江蘇省南京市棲霞區緯地路9號江蘇生命科技創新園C6棟3層

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          產品技術轉移


          產品技術轉移是GMP認證檢查的核心內容,也是產品研發和產品報批的關鍵內容。


          技術轉移作為產品從科研向產業化過度的關鍵步驟,需要按照產品技術的本身要求,密切與生產條件相結合,

          同時也需要符合相關的法規規范要求。產品技術轉移項目,需要用科學合理的方法,以及按照規范的程序進行。


          ? 產品技術轉移方案;

          ? 風險管理;

          ? 處方和工藝;

          ? 原材料及供應商;

          ? 質量標準:原輔料、包裝材料、中間產品、成品;

          ? 分析方法驗證

          ? 變更控制;

          ? 清潔驗證;

          ? 工藝驗證;

          ? 穩定性試驗;

          ? 臨床/生物等效性研究;

          ? 產品技術轉移報告;

          ? 產品報批。

           

          新的制藥設施建成后,在進入產品的商業化生產前,首要的任務是產品的技術轉移和產品的報批(新的生產

          批文的申請或原有生產批文的變更補充申請)。

          產品技術轉移需要遵循相關的法規規范,達到產品質量一致性的要求,并完成相應的產品審批。

          產品技術轉移項目,需要用科學合理的方法,以及按照規范的程序進行。

           

          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




           

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