產(chǎn)品研發(fā)
product research and development
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廣州西典醫藥科技有限公司
電話(huà):0769-2223 5501
地址:廣東省東莞市松山湖高新技術(shù)產(chǎn)業(yè)開(kāi)發(fā)區阿里山路19號產(chǎn)業(yè)化中心8棟4樓
東莞西典醫藥科技有限公司
電話(huà):0769-2223 5501
地址:廣東省東莞市松山湖高新技術(shù)產(chǎn)業(yè)開(kāi)發(fā)區阿里山路19號產(chǎn)業(yè)化中心8棟4樓
江蘇西典藥用輔料有限公司
電話(huà):0523-80103166
地址:江蘇省泰州市海陵區中國醫藥城四期標準廠(chǎng)房G56幢一至四層西側
南京西典藥用輔料有限公司
電話(huà):13851889093
地址:江蘇省南京市棲霞區緯地路9號江蘇生命科技創(chuàng )新園C6棟3層
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產(chǎn)品技術(shù)轉移
產(chǎn)品技術(shù)轉移是GMP認證檢查的核心內容,也是產(chǎn)品研發(fā)和產(chǎn)品報批的關(guān)鍵內容。
技術(shù)轉移作為產(chǎn)品從科研向產(chǎn)業(yè)化過(guò)度的關(guān)鍵步驟,需要按照產(chǎn)品技術(shù)的本身要求,密切與生產(chǎn)條件相結合,
同時(shí)也需要符合相關(guān)的法規規范要求。產(chǎn)品技術(shù)轉移項目,需要用科學(xué)合理的方法,以及按照規范的程序進(jìn)行。
? 產(chǎn)品技術(shù)轉移方案;
? 風(fēng)險管理;
? 處方和工藝;
? 原材料及供應商;
? 質(zhì)量標準:原輔料、包裝材料、中間產(chǎn)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(chǎn)品技術(shù)轉移報告;
? 產(chǎn)品報批。
新的制藥設施建成后,在進(jìn)入產(chǎn)品的商業(yè)化生產(chǎn)前,首要的任務(wù)是產(chǎn)品的技術(shù)轉移和產(chǎn)品的報批(新的生產(chǎn)
批文的申請或原有生產(chǎn)批文的變更補充申請)。
產(chǎn)品技術(shù)轉移需要遵循相關(guān)的法規規范,達到產(chǎn)品質(zhì)量一致性的要求,并完成相應的產(chǎn)品審批。
產(chǎn)品技術(shù)轉移項目,需要用科學(xué)合理的方法,以及按照規范的程序進(jìn)行。
Oral Solid Dosage Form Development
Stage
|
Firm’s 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 |