PharmSol 对成品、原料药、中间体和关键起始物料(KSM)进行了完整的一系列审计,以确保 全球客户的产品安全和质量。PharmSol 拥有内部审计团队,审计官通过了各种认证,包括 APIC/CEFIC/ASQ CQA/IRCA 认证。PharmSol 是首批根据 EC 指令 2004/27/EC 对其欧洲客户进行 第三方 GMP 审计的公司之一。PharmSol 已在全球成功进行了 1000 多次 GMP 审计。
PharmSol 根据 ICH Q7、EudraLex 第 4 卷、美国联邦法规 21 章第 11 部分和 PIC/s 药品生产质
量管理规范指南(2017 年 1 月)对生产现场进行确认。
除 GMP 审计外,PharmSol 集团还对研发和分析实验室、CRO、仓储和分发网络进行审计。
PharmSol 还提供独特的商业模式,通过这种模式,原料药、关键起始物料和辅料的生产商可
以显著减少第三方审计和后续 CAPA 的工作量。立即与我们联系,探索独特创新的批量审计
或共享审计业务模式。
PharmSol 集团提供质量尽职调查支持,帮助公司从合规和投资角度审查其厂房。
从环境管理的角度来看,EHS 审计的实施是一项重要内容。PharmSol 集团及其经认证的审计
官团队可协助公司进行 EHS 审计。
Products (API/KSM/Intermediate) | Country | Select Report |
---|---|---|
10-Deacetyl Baccatin III (Intermediate) | China | |
1-chloro-3,5-dimethyladamantane (Intermediate) | Latvia | |
2-Thiophene Ethanol Intermediate | China | |
4-methoxy 2,3,6-trimethyl Benzaldehyde (Intermediate) | China | |
6-Methyluracil | India | |
Acid Acetilsalicilic | China | |
Albendazole | India | |
Ambrisentan | India | |
Ambrisentan (Intermediate) | India | |
Ambroxol Hydrochloride | India | |
Amlodipine | India | |
Amlodipine Besylate | India | |
Amoxicillin Trihydrate | India | |
Anastrozole | India | |
Anlotinib Hydrochloride (Capsules) | India | |
Apremilast | India | |
Aprepitant | India | |
Aripiprazole | India | |
Ascorbic Acid | India | |
Atorvastatin Calcium | India | |
Atorvastatin Calcium (Intermediate) | India | |
Atorvastatin Calcium Trihydrate | India | |
Azithromycin | India | |
Beclomethasone Dipropionate | India | |
Benzocaine | China | |
Beta Lactam Side Chain (Intermediate) | China | |
Betahistine Hydrochloride | 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 | |
Cefepime Hydrochloride and L-Arginine | China | |
Cefoperazone Sodium | China | |
Cefotaxime Sodium Sterile | China | |
Ceftazidime Pentahydrate | China | |
Ceftazidime Pentahydrate with Sodium carbonate | China | |
Ceftriaxone (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 | |
Cilastatin Sodium | India | |
Cinacalcet (Intermediate) | India | |
Cinacalcet Hydrochloride | 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 | |
Cytisine | China | |
Dabigatran Etexilate Mesylate | India | |
Deferasirox | India | |
Dexchlorpheniramine Maleate | India | |
Dexketoprofen Trometamol | India | |
Diclofenac Sodium | India | |
Dimethicone | India | |
Donepezil | India | |
Donepezil Hydrochloride | India | |
Donepezil Hydrochloride (Intermediate) | India | |
Doxorubicin Hydrochloride | India | |
Dronedarone Hydrochloride | India | |
Dronedarone Hydrochloride (Intermediate) | India | |
Dronedarone Hydrochloride (Intermediate) | China | |
Drotaverine Hydrochloride | China | |
Drotaverine Hydrochloride | India | |
Duloxetine Hydrochloride | India | |
Econazole Nitrate | India | |
Epirubicin Hydrochloride | India | |
Eplerenone | China | |
Eplerenone (Intermediate) | China | |
Erythromycin Oxime (Intermediate) | India | |
Exemestane | Taiwan | |
Ezetimibe | India | |
Fampridine | India | |
Febuxostat | India | |
Fesoterodine | India | |
Fexofenadine Hydrochloride | India | |
Finasteride | India | |
Flecainide Acetate | India | |
Fluconazole | India | |
Fluticasone Propionate | India | |
FMOC-Homo-ARG-PBF-OH (KSM) | China | |
Folic Acid | India | |
Formoterol Fumarate Dihydrate | India | |
Fulvestrant | China | |
Furosemide | India | |
Gabapentin | India | |
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 | |
Imipenem Monohydrate | India | |
Imipenem Monohydrate & Cilastatin Sodium | India | |
Irbesartan | India | |
Isoniazid | India | |
Isotretinoin | China | |
Ivabradine | 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 | |
MAEM (Intermediate) | China | |
Magnesium Pidolate | India | |
Meloxicam | India | |
Memantine Hydrochloride | India | |
Memantine Hydrochloride (Intermediate) | India | |
Meropenem Trihydrate | India | |
Meropenem Trihydrate & Sodium Carbonate | India | |
Meropenem Trihydrate Sterile | Italy | |
Metamizole Sodium | China | |
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 | |
Naproxen Base | India | |
Naproxen Sodium | India | |
Naproxen Sodium | China | |
Nicotinic Acid | India | |
Nimesulide | India | |
Olanzapine | India | |
Olanzapine (Intermediate) | India | |
Olmesartan Medoxomil | India | |
Omeprazole | China | |
Ondansetron Hydrochloride Dihydrate | India | |
Oxcarbazepine | India | |
Oxyclozanide | India | |
Paclitaxel Side Chain (Intermediate) | China | |
Paracetamol | China | |
Paracetamol DC 90 Granules | China | |
Paricalcitol | India | |
Pemetrexed Disodium Hemipentahydrate | China | |
Perindopril | India | |
Phenylephrine Hydrochloride | Taiwan | |
Phenylephrine Hydrochloride | India | |
Phthalimido Amlodipine (Intermediate) | India | |
Pio Imino Compound (Intermediate) | China | |
Pioglitazone Hydrochloride | India | |
Piracetam | China | |
Posaconazole | India | |
Posaconazole Amorphous | India | |
Posaconazole KSM | India | |
Praziquantel | India | |
Pregabalin | India | |
Pregabalin | China | |
Pregabalin (Intermediate) | India | |
Pregabalin (Intermediate) | China | |
Pyrazinamide | India | |
Quetine Fumarate | India | |
Rafoxanide | India | |
Ramipril | China | |
Ranitidine Hydrochloride | India | |
Rasagiline | India | |
Riboflavin 5 - Phosphate sodium | India | |
Rifampicin | China | |
Riluzole | Taiwan | |
Risperidone | India | |
Rivastigmine Hydrogen Tartrate | India | |
Ropinirole Hydrochloride | India | |
Rosuvastatin Calcium | India | |
Salmeterol Xinafoate | India | |
Scopolamine Hydrobromide | India | |
Sildenafil Citrate | India | |
Sildenafil Citrate (Intermediate) | India | |
Simvastatin | India | |
Sitagliptin Hydrochloride | India | |
Sitagliptin Hydrochloride (Intermediate) | China | |
Sodium Alendronate Trihydrate | India | |
Solifenacin Succinate | India | |
Solifenacin Succinate (Intermediate) | India | |
Stoppers (Packing Material) | France | |
Succinylcholine Chloride | India | |
Sugammadex (Injection) | China | |
Sulbactam | China | |
Sulbactam Sodium | China | |
Sulfadimidine | China | |
Tadalafil | India | |
TAEM (Intermediate) | China | |
Telmisartan | India | |
Temozolomide | India | |
Terbinafine Hydrochloride | India | |
Ticagrelor | India | |
Ticagrelor (Intermediate) | India | |
Tiotropium Bromide Monohydrate | India | |
Tramadol Hydrochloride | India | |
Tranexamic Acid | China | |
Type-I Clear Glass Vials | France | |
Valganciclovir (KSM) | India | |
Valsartan | India | |
Valsartan (Intermediate) | China | |
Valsartan (Intermediate) | India | |
Vildagliptin | India | |
Vildagliptin (Intermediate) | India | |
Vildagliptin (Intermediate) | China | |
Vinorelbine Tartrate | China | |
Voriconazole | India |
Bad Oldesloe, Germany
Mosta, Malta
Jebel Ali, Dubai, United Arab Emirates
Jumeirah Lake Towers, Dubai
Heliopolis, Cairo, Egypt
Hyderabad, India
中国 江苏省 南京市
中国 香港
Makati City, Philippines
Ho Chi Minh City, Vietnam