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
Ambrisentan India
Amlodipine Besylate India
Amoxicillin Trihydrate India
Anastrozole India
Aprepitant India
Aripiprazole India
Ascorbic Acid China
Atorvastatin Calcium India
Atorvastatin Calcium Intermediate India
Bicalutamide India
Bromhexine Hydrochloride India
Budesonide India
Captopril China
Cefazolin Sodium Sterile Italy
Cefepime Hydrochloride Sterile China
Ceftazidime Pentahydrate with Sodium Carbonate Sterile China
Cetirizine Dihydrochloride India
Chloramphenicol Palmitate India
Chlorpheniramine Maleate India
Choline Theophylinate India
Cinacalcet Hydrochloride India
Ciprofloxacin Hydrochloride India
Citalopram Hydrobromide India
Clarithromycin India
Clarithromycin China
Clopidogrel Hydrogen Sulphate India
Closantel Base India
Closantel Sodium India
Clotrimazole India
Cloxacillin Sodium India
Dabigatran Etexilate Mesylate India
Deferasirox 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
Ezetimibe India
Fampridine India
Febuxostat India
Fesoterodine India
Fluticasone Propionate India
Folic Acid India
Formoterol Fumarate Dihydrate India
Furosemide India
Gabapentin India
Gentamicin Sulfate China
Gliclazide China
Glucosamine Hydrochloride India
Heparin China
Hydrochlorothiazide China
Hydrochlorothiazide India
Hydrocortisone China
Hydrocortisone Acetate China
Hyoscine Butyl Bromide India
Imipenem Cilastatin Sterile Italy
Irbesartan India
Lacosamide India
Lacosamide Intermediate India
Lactose Germany
Lamotrigine India
Levetirecetam India
Levocetirizine Dihydrochloride India
Loratadine India
Magnesium Pidolate India
Meloxicam India
Memantine Hydrochloride India
Meropenem Trihydrate Sterile Italy
Metformin Hydrochloride India
Metformin Hydrochloride DC India
Miconazole Nitrate India
Modafinil India
Moxifloxacin Hydrochloride India
Naproxen Base India
Naproxen Sodium China
Naproxen Sodium India
Nimesulide India
Olanzne India
Omeprazole China
Oxyclozanide India
Paracetamol DC 90 Granules China
Paracetamol China
Phenylephrine Hydrochloride Taiwan
Phenylephrine Hydrochloride India
Pioglitazone Hydrochloride India
Piracetam China
Posaconazole Amorphous India
Posaconazole Form I India
Praziquantel India
Pregabalin China
Pregabalin India
Hydroxizine India
Celecoxib India
Quetine Fumarate (Form I) India
Rafoxanide India
Ramipril China
Ranitidine Hydrochloride India
Ranitidine Hydrochloride (Form-II) India
Rasagiline India
Riboflavin 5'-Phosphate Sodium India
Rosuvastatin Calcium India
Salmeterol Xinafoate India
Sildenafil Citrate India
Simvastatin India
Sodium Alendronate Trihydrate India
Solifenacin Succinate India
Succinylcholine Chloride India
Sulfadimidine China
Terbinafine Hydrochloride India
Thiohene 2-ethanol China
Tiotropium Bromide Monohydrate India
Tramadol Hydrochloride India
Valsartan India
Vildagliptin India
Voriconazole India

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Our Establishments

PharmSol GmbH

Bad Oldesloe, Germany

PharmSol Europe Limited

Balzan, 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