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

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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