GMP审计
PharmSol在全球开展全面的审计来确保产品的安全和质量，包括成品、原料药、中间体、关键起始物料等。PharmSol拥有自己的专业审计团队，获得的认证包括 APIC/CEFIC/ASQ CQA/IRCA。 PharmSol作为第一家为欧洲客户按照 EC Directive 2004/27/EC指南的要求下开展第三方GMP审计的服务公司，目前已经在全球成功开展了超过900次GMP审计。 如果您正在寻找有效的审计报告，请参阅以下清单并点击您所需的具体产品
GMP 审计(QP审计)
PharmSol可根据ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11; PIC/s GMP医药产品2017年1月的指南; 以及《药品生产质量管理规范2010年修订版》(卫生部第79号法令) 法规要求来开展生产场地的审计确认。
GLP/GCP/GDP 审计
除了GMP审计，PharmSol也可以开展以下审计，包括产品开发和检验分析实验室、CRO、仓库以及物流运输环节
可共享的审计
PharmSol同时对原料药、关键起始物料、辅料的生产商提供独特的商业模式，以来显著降低其第三方审计以及后续CAPA的工作量。欢迎同我们联系来共同探讨可共享的审计商业模式。
质量尽职调查
PharmSol可提供质量尽职调查服务来支持企业对其工厂的合规性以及从投资方面的决策。
安全审计（EHS）
EHS审计的开展对于环境管理是非常重要的。PharmSol拥有认证资质的审计团队，可以帮助公司开展EHS审计。
GMP审计报告列单
按Ctrl + F键搜索产品名称
| API | 国家 | 选择报告 |
|---|---|---|
| Ambrisentan | India |
 
|
| Amlodipine Besylate | India |
|
| Amoxicillin Trihydrate | India |
|
| Anastrozole | India |
|
| Aprepitant | India |
|
| Aripiprazole | India |
|
| Ascorbic Acid | China |
|
| Atorvastatin Calcium | India |
|
| Atorvastatin Calcium Intermediate | India |
|
| Bicalutamide | India |
|
| Bromhexine Hydrochloride | India |
|
| Budesonide | India |
|
| Captopril | China |
|
| Cefazolin Sodium Sterile | Italy |
|
| Cefepime Hydrochloride Sterile | China |
|
| Ceftazidime Pentahydrate with Sodium Carbonate Sterile | China |
|
| Cetirizine Dihydrochloride | India |
|
| Chloramphenicol Palmitate | India |
|
| Chlorpheniramine Maleate | India |
|
| Choline Theophylinate | India |
|
| Cinacalcet Hydrochloride | India |
|
| Ciprofloxacin Hydrochloride | India |
|
| Citalopram Hydrobromide | India |
|
| Clarithromycin | China |
|
| Clarithromycin | India |
|
| Clopidogrel Hydrogen Sulphate | India |
|
| Closantel Base | India |
|
| Closantel Sodium | India |
|
| Clotrimazole | India |
|
| Cloxacillin Sodium | India |
|
| Dabigatran Etexilate Mesylate | India |
|
| Deferasirox | India |
|
| Diclofenac Sodium | India |
|
| Dimethicone | India |
|
| Donepezil | India |
|
| Donepezil Hydrochloride Form I | India |
|
| Doxorubicin Hydrochloride | India |
|
| Dronedarone Hydrochloride | India |
|
| Drotaverine Hydrochloride | China |
|
| Duloxetine Hydrochloride | India |
|
| Econazole Nitrate | India |
|
| Epirubicin Hydrochloride | India |
|
| Eplerenone | China |
|
| Ezetimibe | India |
|
| Fampridine | India |
|
| Febuxostat | India |
|
| Fesoterodine | India |
|
| Fluticasone Propionate | India |
|
| Folic Acid | India |
|
| Formoterol Fumarate Dihydrate | India |
|
| Furosemide | India |
|
| Gabapentin | India |
|
| Gentamicin Sulfate | China |
|
| Gliclazide | China |
|
| Glucosamine Hydrochloride | India |
|
| Heparin | China |
|
| Hydrochlorothiazide | China |
|
| Hydrochlorothiazide | India |
|
| Hydrocortisone | China |
|
| Hydrocortisone Acetate | China |
|
| Hyoscine Butyl Bromide | India |
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| Imipenem Cilastatin Sterile | Italy |
|
| Irbesartan | India |
|
| Lacosamide | India |
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| Lacosamide Intermediate | India |
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| Lactose | Germany |
|
| Lamotrigine | India |
|
| Levetirecetam | India |
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| Levocetirizine Dihydrochloride | India |
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| Loratadine | India |
|
| Magnesium Pidolate | India |
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| Meloxicam | India |
|
| Memantine Hydrochloride | India |
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| Meropenem Trihydrate Sterile | Italy |
|
| Metformin Hydrochloride | India |
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| Miconazole Nitrate | India |
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| Modafinil | India |
|
| Moxifloxacin Hydrochloride | India |
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| Naproxen Base | India |
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| Naproxen Sodium | China |
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| Naproxen Sodium | India |
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| Nimesulide | India |
|
| Olanzne | India |
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| Omeprazole | China |
|
| Oxyclozanide | India |
|
| Paracetamol DC 90 Granules | China |
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| Paracetamol | China |
|
| Phenylephrine Hydrochloride | Taiwan |
|
| Phenylephrine Hydrochloride | India |
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| Pioglitazone Hydrochloride | India |
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| Piracetam | China |
|
| Posaconazole Amorphous | India |
|
| Posaconazole Form I | India |
|
| Praziquantel | India |
|
| Pregabalin | China |
|
| Pregabalin | India |
|
| Hydroxizine | India |
|
| Celecoxib | India |
|
| Quetine Fumarate (Form I) | India |
|
| Rafoxanide | India |
|
| Ramipril | China |
|
| Ranitidine Hydrochloride | India |
|
| Ranitidine Hydrochloride (Form-II) | India |
|
| Rasagiline | India |
|
| Riboflavin 5'-Phosphate Sodium | India |
|
| Rosuvastatin Calcium | India |
|
| Salmeterol Xinafoate | India |
|
| Sildenafil Citrate | India |
|
| Simvastatin | India |
|
| Sodium Alendronate Trihydrate | India |
|
| Solifenacin Succinate | India |
|
| Succinylcholine Chloride | India |
|
| Sulfadimidine | China |
|
| Terbinafine Hydrochloride | India |
|
| Thiohene 2-ethanol | China |
|
| Tiotropium Bromide Monohydrate | India |
|
| Tramadol Hydrochloride | India |
|
| Valsartan | India |
|
| Vildagliptin | India |
|
| Voriconazole | India |
|
您的报告
选择您挑选的报告感兴趣？了解更多？请联系我们
我们的机构
PharmSol GmbH
Bad Oldesloe, Germany
PharmSol Europe Limited
Balzan, Malta
Pharmaceutical Solutions FZCO
Jebel Ali, Dubai, United Arab Emirates
Pharmaceutical Solutions DMCC
Jumeirah Lakes Towers, Dubai, United Arab Emirates
PharmSol India Pvt. Ltd.
Hyderabad, India
PharmSol (Nanjing) Pharmaceutical Technology Co.Ltd
Nanjing City, Jiangsu Province, PR China
PharmSol APAC Limited
Hong Kong, China
谢谢！
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