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 |
|---|---|---|
| 10-Deacetyl Baccatin III (Intermediates) | China |
 
|
| 1-Benzyl-4-(5, 6-dimethoxy-1-Oxoindan-2-ylindenemethyl) Piperidine (DHA) | India |
|
| 1-Bromo-3,5-Dimethyladamantane (MEA) Intermediate | India |
|
| 1-chloro-3,5-dimethyladamantane (M613) Intermediate | Latvia |
|
| 2-Thiophene Ethanol Intermediate | China |
|
| 4-methoxy 2,3,6-trimethyl Benzaldehyde | India |
|
| 6-Methyluracil | India |
|
| Acid Acetilsalicilic | China |
|
| Ambrisentan | India |
|
| Ambrisentan Intermediate | India |
|
| Ambroxol Hydrochloride | India |
|
| Amlodipine Besylate | India |
|
| Amoxicillin Trihydrate | India |
|
| Anastrozole | India |
|
| Apremilast | India |
|
| Aprepitant | India |
|
| Aripiprazole | India |
|
| Ascorbic Acid | China |
|
| Atorvastatin Calcium | India |
|
| Atorvastatin Calcium Intermediate | India |
|
| Atorvastatin Calcium Trihydrate | India |
|
| Azithromycin | India |
|
| Beclomethasone Dipropionate | India |
|
| Benzocaine | China |
|
| Beta Lactam Side Chain (Intermediate) | India |
|
| Betamethasone Dipropionate | India |
|
| Betamethasone Sodium Phosphate | India |
|
| Betamethasone Valerate | India |
|
| Bicalutamide | India |
|
| Bifonazole | India |
|
| Bromhexine Hydrochloride | India |
|
| Budesonide | India |
|
| Canagliflozin | India |
|
| Captopril | China |
|
| Cefazolin Sodium Sterile | Italy |
|
| Cefazolin Sodium Sterile | China |
|
| Cefepime | China |
|
| Cefepime Dihydrochloride Monohydrate sterile | China |
|
| Cefotaxime Sodium Sterile | China |
|
| Ceftazidime Pentahydrate with Sodium carbonate | China |
|
| Ceftriaxone Intermediate (7-ACT) Intermediate | China |
|
| Ceftriaxone Sodium Sterile | China |
|
| Cefuroxime Sodium Sterile | China |
|
| Cefuroxime Sodium Sterile | India |
|
| Cefuroxime Sodium Sterile | Italy |
|
| Celecoxib Capsules | India |
|
| Cetirizine Dihydrochloride | India |
|
| Chloramphenicol Palmitate | India |
|
| Chlorpheniramine Maleate | India |
|
| Choline Theophylinate | India |
|
| Cinacalcet Hydrochloride | India |
|
| Cinacalcet Intermediate (R-(+)-1-(1-Naphthyl) Ethylamine Mandalate Salt) | India |
|
| Ciprofloxacin Hydrochloride | India |
|
| Cisatracurium Besilate | Spain |
|
| Citalopram Hydrobromide | India |
|
| Citicoline Sodium | China |
|
| Clarithromycin | China |
|
| Clarithromycin | India |
|
| Clobetasol Propionate | India |
|
| Clopidogrel Hydrogen Sulphate | India |
|
| Closantel Base | India |
|
| Closantel Sodium | India |
|
| Clotrimazole | India |
|
| Cloxacillin | India |
|
| Dabigatran Etexilate Mesylate | India |
|
| Deferasirox | India |
|
| Dexchlorpheniramine Maleate | 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 |
|
| Eplerenone Intermediate | China |
|
| Ezetimibe | India |
|
| Fampridine | India |
|
| Febuxostat | India |
|
| Febuxostat (Form-G) | India |
|
| Fesoterodine | India |
|
| Fexofenadine Hydrochloride | India |
|
| Flecainide Acetate | India |
|
| Fluconazole | India |
|
| Fluticasone Propionate | India |
|
| FMOC-Homo-ARG-PBF-OH (KSM) | China |
|
| Folic Acid | India |
|
| Formoterol Fumarate Dihydrate | China |
|
| Furosemide | India |
|
| Gabapentin | China |
|
| Gentamicin Sulfate | China |
|
| Gliclazide | China |
|
| Glucosamine Hydrochloride | India |
|
| Glybenclamide | India |
|
| Griseofulvin | China |
|
| Heparin | China |
|
| Hydrochlorothiazide | China |
|
| Hydrochlorothiazide | India |
|
| Hydrocortisone | China |
|
| Hydrocortisone Acetate | China |
|
| Hydroxizine Tablets | India |
|
| Hyoscine Butyl Bromide | India |
|
| Ibuprofen | India |
|
| Imipenem Cilastatin Sterile | Italy |
|
| Intermediate MAEM | China |
|
| Irbesartan | India |
|
| Isoniazid | India |
|
| Ivabradine Intermediate | India |
|
| Ivabradine Intermediate | China |
|
| Ketotifen Hydrofumarate | China |
|
| Lacosamide | India |
|
| Lacosamide Intermediate | India |
|
| Lactose | Germany |
|
| Lamotrigine | India |
|
| Letrozole | India |
|
| Levetiracetam | India |
|
| Levocetirizine Dihydrochloride | India |
|
| Lincomicin Hydrochloride | China |
|
| Lisinopril Dihydrate | China |
|
| Loratadine | India |
|
| M-077: 2-Hydroxy-5-nitro benzyl triphenyl phosphonium bromide moiety | India |
|
| M-077: 2-Hydroxy-5-nitro benzyl triphenyl phosphonium bromide moiety Intermediate | China |
|
| Magnesium Pidolate | India |
|
| Meloxicam | India |
|
| Memantine Hydrochloride | India |
|
| Meropenem Trihydrate Sterile | Italy |
|
| Metformin Hydrochloride | India |
|
| Metformin Hydrochloride DC | India |
|
| Metoclopramide Hydrochloride | India |
|
| Miconazole Nitrate | India |
|
| Mirabegron | India |
|
| Modafinil | India |
|
| Mometasone Furoate | India |
|
| Montelukast Sodium | India |
|
| Moxifloxacin Hydrochloride | India |
|
| Moxifloxacin Hydrochloride Monohydrate | India |
|
| Mycophenolate Mofetil | India |
|
| N-(3,5-Dimethyl-1-Adamentyl) Acetamide (MEB) Intermediate | India |
|
| Naproxen Base | India |
|
| Naproxen Sodium | India |
|
| Naproxen Sodium | China |
|
| Nimesulide | India |
|
| Olanzapine | India |
|
| Olanzapine Intermediate (5-Methyl-2-(2-nitroanilino) thiophene-3-carbonitrile) | India |
|
| Olanzapine Intermediate (Amino benzodiazepine hydrochloride) | India |
|
| Olmesartan Medoxomil | India |
|
| Omeprazole | China |
|
| Ondansetron Hydrochloride Dihydrate | India |
|
| Oxcarbazepine | India |
|
| Oxyclozanide | India |
|
| Oxcarbazepine | India |
|
| Oxyclozanide | India |
|
| Paclitaxel Side Chain (Intermediate) | China |
|
| Paracetamol | China |
|
| Paracetamol DC 90 Granules | China |
|
| Paricalcitol | India |
|
| Perindopril | India |
|
| Phenylephrine Hydrochloride | Taiwan |
|
| Phenylephrine Hydrochloride | India |
|
| Pio Imino Compound (Intermediate) | China |
|
| Pioglitazone Hydrochloride | India |
|
| Piracetam | China |
|
| Posaconazole Amorphous | India |
|
| Posaconazole Form I | India |
|
| Praziquantel | India |
|
| Pregabalin | India |
|
| Pregabalin | China |
|
| Pregabalin Intermediate | India |
|
| Pregabalin Intermediate (R-(-)-3-(2-amino-2-oxoethyl)-5-methyl hexanoic acid) | China |
|
| QUETINE FUMARATE (FORM I) | India |
|
| Rafoxanide | India |
|
| Ramipril | China |
|
| Ranitidine Hydrochloride | India |
|
| Ranitidine Hydrochloride (Form-II) | India |
|
| Rasagiline | India |
|
| Riboflavin 5 - Phosphate sodium | India |
|
| Rifampicin (Form I) | China |
|
| Risperidone | India |
|
| Ropinirole Hydrochloride | India |
|
| Rosuvastatin Calcium | India |
|
| Salmeterol Xinafoate | India |
|
| Scopolamine Hydrobromide | India |
|
| Sildenafil Citrate | India |
|
| Sildenafil Citrate Intermediate (5-(2- ethoxyphenyl)-1-methyl-3-n-propyl-1, 6 dihydro-7 H- pyrazolo-[4, 3-d] pyrimidine-7-one) (EMP)) | India |
|
| Sildenafil Intermediate | India |
|
| Simvastatin | India |
|
| Sitagliptin Hydrochloride | India |
|
| Sitagliptin Hydrochloride Intermediate (SMS (Boc-(R)-3-Amino-4-(2,4,5-triflurophenyl) butanoic acid)) | China |
|
| Sodium Alendronate Trihydrate | India |
|
| Solifenacin Succinate | India |
|
| Succinylcholine Chloride | India |
|
| Sulbactam Sodium | China |
|
| Sulfadimidine | China |
|
| Tadalafil | India |
|
| Telmisartan | India |
|
| Temozolomide | India |
|
| Terbinafine Hydrochloride | India |
|
| Ticagrelor Form II | India |
|
| Tiotropium Bromide Monohydrate | India |
|
| Tramadol Hydrochloride | India |
|
| Type-I Clear Glass Vials | France |
|
| Valganciclovir KSM ((S)-3-(Benzyloxycarbonyl)-4-Isopropyl-2,5-Oxazolidine dione) | India |
|
| Valsartan | India |
|
| Valsartan Intermediate | China |
|
| Valsartan Intermediate (Biphenyl Valine Oxalate) | India |
|
| Vildagliptin | India |
|
| Vildagliptin Intermediate (1-Aminoadamantane-3-ol) | India |
|
| Vildagliptin Intermediate (1-Aminoadamantane-3-ol) | China |
|
| 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
Mosta, 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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