仿制药质量一致性评价改剂型药品评价1. 原辅料控制： 晶型，不同pH条件下溶解度，粒度与粒度分布， pKa， LogP， 原料药和辅料相容性，分析检测辅料与制剂性能相关的关键特性。2. 质量控制：药物在多介质中的溶出曲线，杂质谱与杂质含量，新杂质结构确证，杂质定量测定与毒性水平研究，反映剂型特点其他关键项目。3. 稳定性试验：性状，溶出曲线，杂质谱及新增杂质及含量测定。改盐基药品评价1. 原料药控制：结构鉴定，成盐证据。理化性质：溶解度（不同 pH, 不同溶剂）， pKa (pKb)，吸湿性（临界相对湿度及吸湿曲线）及晶型。质量控制：结构鉴定确证，杂质分析方法验证。稳定性试验: 各质控项目试验的比较和分析, 晶型,有关物质及含量测定等。2. 制剂 2.1 剂型与产品组成 2.2 原辅料控制：晶型，不同 pH 条件下溶解性，粒度分布，pKa, LogP 及原料药和辅料相容性等 2.3 质量控制 2.4 稳定性试验H & Y Analytical Services is an independent consultant and contractor company for advanced analytical services for pharmaceutical industry. The services involve strategic consulting, including pharmaceutical analytical method design, development, justification of pre-determined acceptance criteria, validation protocol and validation plan to meet FDA and ICH Guidelan requirements. The services also involve reviewing analytical related documents, including QA/QC, justification of specifications, reference standards, Drug Master File (DMF), FDA audit and NDA/ANDA submission.H&Y Analytical Services171 E. Brittany LnHainesville, IL 60030E-mail: hyanalyticalservices@gmail.comPhone: 847-527-8581Mobile；224-360-9369

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热烈祝贺杭州领业医药有限公司在2018年9月通过了FDA的GMP和ANDA批准前现场检查。这个才成立两年的QC实验室，第一次接受FDA现场检查就以零缺陷通过！！！

提供药物分析指导，培训，研发问题解答。提高研发团队技术水平。评估及完善QC实验室GMP符合性，协助QC实验室通过FDA的现场核查。指导ANDA申报文件的准备，审阅及完成。

• Evaluation/qualification of international vendors/suppliers for start materials and intermediates. Review contract lab protocol/result/reports.• Update/prepare DMF (quality) to support regulatory submission/filing in different countries.• Prepare audit and FDA inspection, review analytical methods, validation packages, initial/review gap assessments from start materials, intermediate, in-process testing to final API. Develop responses to FDA questions. Coordinate responses and explain to gaps, discrepancies or issues.• Review/approval change requests (CR) for regulatory test method (RTM).Lipase, Amylase and Protease test in Pancrelipase.

As a SME, responsible for: • Analytical support API manufacture from raw material, in-process, PJ/PV to QC API release.• Analytical support API commercial release in TPM by review/pre-approval COAs, analytical data and resolve analytical issues. • Review TPM related QA/QC documents, including laboratory investigation report (LIR), OOS, CAPA, CR, VCR, exception documents, method validation package to meet USP/EP/JP requirements and compliance with cGMP/FDA/ICH requirements. • Justification of new and changed specification, stability retests periods and extensions.• Troubleshooting, simplify analytical method for cost-efficiency and effectiveness.• As group leader of continue education, collected information of new analytical technologies, columns, instruments, and USP/EP/ new requirements. Arrange onsite seminars/presentations.Major achievements: • Responsible for the API released in a TPM. No analytical issues from internal audits and FDA inspections for more than 5 years at the TPM for this API. • Good communication skills as liaison between groups within Abbott QC/QA, regulatory and TMPs in many countries for a wide variety of analytical aspects. A Gold Award was obtained for this accomplishment.• Improved/simplified a USP/EP HPLC method for cyclosporine assay and related impurities.• For an incoming intermediate, evaluated 8 international vendors, (including reviewed DMFs, COAs, tested samples,) qualified 4 vendors, recommended 2 vendors with successful validation runs and stability data.• Developed/validated a novel endotoxin LAL method to determination of "hidden" endotoxin in a biological drug product and in-process samples.• As the first author, issued + 100 internal scientific reports, memoirs, plus BOPs, STMs and RTMs. Obtained 2 Gold awards, 7 Silver Awards and several other awards.

Responsible for:• Physical/chemical characterization of new drug candidate, bulk drugs/dosage form/excipients, including solubility/stability/shelf-life, x-ray powder diffraction (PXDR), pKa/LogD, TGA/DSC, USP dissolution/intrinsic dissolution rate (IDR), excipient/drug compatibility, solid state pharmaceuticals, viscosity, solvate/hydrate, particle size (wet/dry), hot-stage microscopy, VTI.Major achievement: • For an on market drug product with a serious dissolution problem, found and demonstrated the root cause (a new, and more stable crystal form with significant lower solubility). Based on the finding, the drug product was re-formulated and kept on the market. This outstanding performance and lasting contribution was recognized and awarded.

Responsible for:• Troubleshooting and improve an analytical method for a contracted OTC drug product stability testing. Develop/validate analytical methods for new and existing formulations.• Maintained a QC lab instruments and initial/review SOPs, IQ/OQ/PQ documents to compliance with cGMP/FDA requirements, dealing with QA audit and FDA inspection. • Assisted PhD students for instrument analysis lab work.Major achievements: • Improved and stabilized a challenged stability method, tested/released more than 100 stability samples per month for a contract OTC sample. This work enables the continuation of the contract for the QC lab.• Recommended by the Dean office and three famous professors of College of Pharmacy, University Iowa, to US immigration office as "National Interest First Priority" candidate for US Permanent Resident, and obtained the USA "Green Card" for me and my family.

• Responsible for develop a challenging analytical method for determination of tea polyphenols in human and animal fluids, including the test of metabolites both in vivo and in vitro by using rat liver perfusion, hepatocytes, S-9 and microsomes.Major achievements • Developed a novel 8-channel, 3-D HPLC-ECD method combination with enzyme digestion of the sample. Demonstrated for the first time that the determination of tea polyphenol (EGCG) in human plasma and urine. The results were published. A $1 million additional research funding was obtained for continued studies.

• As keynote speaker, responsible for the courses of "Advanced Bioanalytical Chemistry", • As keynote speaker, responsible for the courses of "Advanced Bioanalytical Chemistry", "Bioengeenering & Biotechnology" and "Drug Metabolism" for MS degree students.• As the group leader, responsible for the China National Bioengineering/Biotechnology Project. • As the project leader, responsible for a bio-engineering project of China Pharmaceutical University.Major achievement: Developed a chromatographic MS method, separated, and identified 14 drug metabolites of a Chines traditional medicine in rat urine. The results were lectured in "Shanghai International Conference for Chines Medicine", and published.

Responsible for drug analysis and local drug quality control, including sample testing and inspection of local pharmaceutical companies and hospital formulation preparation rooms.