GMP Audit Reports

Our international team at Diapharm Global Audit Solutions organises audits to verify the compliance of API & Excipient manufacturers according to GMP criteria.

Audit Services with Highest Quality and Independence

Our audits are carried out by qualified auditors of blue inspection body, an accredited and independent inspection body. The accreditation ISO 17020 (type A) ensures the highest quality and independence as well as the best possible acceptance of the audit reports by authorities worldwide.

Diapharm coordinates audits in a 4-Way Audit System so that auditors are commercially independent of both the manufacturer and the client. The auditors will provide the audit report regardless of the outcome of the audit.

Our audit services include:

  • Complete audit report
  • Documents on the qualification and independence of auditors
  • CAPA plan and declaration to confirm the GMP compliance of the manufacturer
  • CAPA Follow-up
  • Management of required documents, e.g. CDAs and contracts

Diapharm's independent 4-way-Audit-System:

Your advantages:

  • Highest quality (Type A accredited)
  • Cost-efficient audits
  • More time and capacity for your quality management
  • Internationally accepted GMP audit reports

Diapharm is a leading provider of audits of API and Excipient manufacturers, among other types of audits. For detailed information on whether a current audit report is available for your specific products, please click on the production site and send us a request.

For an overview of all audit reports, please contact us!
Contact our international team: audits@diapharm.de! audits(at)diapharmREMOVETHIS.de
 

Eimear Schulte
Associate Director Global Audit Solutions
Christine Brauner
Consultant

Choose the APIs for which you need an audit report / a new API audit

We also provide audits of starting materials, excipients and intermediates.








Selected entries:

API
Ebastine Fumarate
Ecabet Sodium
Econazole
Econazole Nitrate
Edaravone
Edoxaban
Efavirenz
Eletriptan
Eletriptan HBr
Eliglustat Tartrate
Eliglustat Tartrate
Eliglustat Tartrate
Eltrombopag Olamine
Elvitegravir
Emedastine Difumarate
Empagliflozin
Emtricitabine
Enalapril
Enalapril Maleate
Enilconazole
Enocitabine
Enoxacin
Enoxaparin Sodium
Enprofylline
Enrofloxacin
Enrofloxacin HCl
Entacapone
Entecavir
Entecavir Monohydrate
Eosin Disodium
Epalrestat
Eperisone HCl
Ephedrine HCl
Ephedrine Sulfate
Ephedrine Tannate
Epinastine
Epinastine HBr
Epinastine HCl
Epinephrine (Adrenaline)
Epinephrine Tartrate
Epirubicin
Epirubicin HCl
Eplerenone
Epothilone B
Eprinomectin
Eprosartan
Eprosartan Mesylate
Eptifibatide
Erdosteine
Ergoloid Mesylate (Codergocrine Mesylate)
Ergometrine Maleate (Ergonovine Maleate)
Ergonamine Tartrate
Ergosterol
Ergotamine Tartrate
Eribulin Mesylate
Erlotinib
Erlotinib HCl
Ertapenem
Ertapenem Sodium
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin Lactobionate
Erythromycin Oxime Base
Erythromycin Phosphate
Erythromycin Propionate
Erythromycin Stearate
Erythromycin Thiocyanate
Escitalopram
Escitalopram HBr
Escitalopram Oxalate
Eslicarbazepine
Eslicarbazepine Acetate
Esmolol HCl
Esomeprazole
Esomeprazole Cyclodextrin Complex
Esomeprazole Dihydrate
Esomeprazole Magnesium
Esomeprazole Magnesium Dihydrate
Esomeprazole Magnesium Trihydrate
Esomeprazole Potassium
Esomeprazole Sodium
Esomeprazole Trihydrate
Estazolam
Estradiol
Estradiol Benzoate
Estradiol Cypionate
Estradiol Hemihydrate
Estradiol Valerate
Estramustine
Estramustine Phosphate
Estramustine Sodium Phosphate
Estriol
Eszopiclone
Etacrynic Acid
Etamiphylline
Etamiphylline Camsylate
Etamsylate
Ethacridine Lactate
Ethacrynate Sodium
Ethacrynic Acid
Ethambutol
Ethambutol HCl
Ethaverine
Ethinyl Estradiol
Ethionamide
Ethopabate
Ethosuximide
Ethyl L-Cysteine HCl
Ethyl Salicylate
Ethylamine
Ethyleicosapentaenoic Acid
Ethyleneglycol Salicylate
Ethylmorphine HCl
Etidronate Disodium
Etilefrine HCl
Etizolam
Etodolac
Etofenamate
Etofylline (Theofibrate)
Etofylline Nicotinate
Etomidate
Etonogestrel
Etoposide
Etoposide Phosphate
Etoricoxib
Etravirine
Everolimus
Exemestane
Exenatide
Ezetimibe

 

Every GMP compliance audit is subject to a signed and valid confidentiality agreement with the audited API supplier. We obtain the API supplier’s consent prior to distribution of the audit report.

Contact us!
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