Gmp/QP Audits

PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). PharmSol has in-house team of Auditors who are accredited with various certifications including APIC/CEFIC/ASQ CQA/IRCA. PharmSol is one of the first companies to have conducted third party GMP audits for its European clients in compliance with EC Directive 2004/27/EC. PharmSol has successfully conducted over 900 GMP audits across the globe.

GMP Audits (QP Audits)

PharmSol conducts qualification of the manufacturing sites in accordance with ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11; PIC/s Guide to Good Manufacturing Practice for Medicinal Products, January 2017; and Good Manufacturing Practice for Drugs 2010 Revision (MOH Decree No. 79).

GLP/GCP/GDP Audits

In addition of GMP Audits, PharmSol Group also conducts Audit of Development and Analytical Laboratory, CRO, Warehousing & Distribution Network.

Bulk Audits/Shared Audits

PharmSol also offers unique business models whereby manufacturers of APIs, KSMs, Excipients can significantly reduce their load of Third Party Audits and consequent CAPAs. Get in touch with us now and explore the unique and innovative Bulk Audits or Shared Audits business model.

Quality Due Diligence

PharmSol Group offers Quality Due Diligence support facilitating company’s review their facility from Compliance & Investment perspective.

Supply Security Audits (EHS)

Implementation of EHS Audits are important element from environmental management perspective. PharmSol Group with its team of certified Auditors can assist companies for EHS Audit.

GMP Audit Reports

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API Country Select Report
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 China
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) China
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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Our Establishments

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