PharmSol führt die komplette Auditkette durch, die den Kunden auf der ganzen Welt Produktsicherheit und -qualität für Endprodukte, APIs, Zwischenprodukte und wichtige Ausgangsmaterialien (KSMs) gewährleistet. PharmSol verfügt über ein eigenes Team von Auditoren, die mit verschiedenen Zertifizierungen wie APIC/CEFIC/ASQ CQA/IRCA akkreditiert sind. PharmSol ist eines der ersten Unternehmen, das für seine europäischen Kunden GMP-Audits nach der EG-Richtlinie 2004/27/EG durchgeführt hat. PharmSol hat weltweit bis heute mehr als 1,000 GMP-Audits erfolgreich durchgeführt.
PharmSol führt die Qualifizierung der Produktionsstandorte in Übereinstimmung mit ICH Q7, EudraLex Volume 4, Code of Federal Regulations 21 CFR Part 11; PIC/s Guide to Good Manufacturing Practice for Medicinal Products, Januar 2017 durch; und Good Manufacturing Practice for Drugs 2010 Revision (MOH Decree No.79)
Zusätzlich zu den GMP-Audits führt die PharmSol Group auch Audits von Entwicklungs- und Analysenlaboren, klinischen Research Organisationen, Warehousing & Distribution Centern durch.
PharmSol bietet auch einzigartige Geschäftsmodelle, mit denen Hersteller von APIs, KSMs und Hilfsstoffen ihre Aufwendungen für Third-Party-Audits und damit CAPAs deutlich reduzieren können. Nehmen Sie jetzt Kontakt mit uns auf und informieren Sie sich über das einzigartige und innovative Geschäftsmodell Bulk Audits oder Shared Audits.
Die PharmSol Group bietet Unterstützung bei der „Quality Due Diligence“ an, die es Unternehmen ermöglicht, ihre Standorte aus Compliance- und Investitionssicht zu überprüfen.
Die Durchführung von EHS-Audits ist aus Sicht des Umweltmanagements ein wichtiges Element. Die PharmSol Group mit ihrem Team von zertifizierten Auditoren kann Unternehmen beim EHS-Audit unterstützen.
Produkte (API/KSM/Zwischenprodukte) | Land | Bericht auswählen |
---|---|---|
10-Deacetyl Baccatin III (Intermediates) | 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) | China |
|
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) | 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 Lakes Towers, Dubai, United Arab Emirates
Hyderabad, India
Nanjing City, Jiangsu Province, PR China
Hong Kong, China
Vielen Dank für Ihre Anfrage. Sie wurde an die zuständige Abteilung weitergeleitet und Ihre Anfrage wird so schnell wie möglich bearbeitet.