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
Famciclovir
Famotidine
Faropenem
Faropenem Sodium
Fasudil HCl
Febantel
Febantel HCl
Febuxostat
Felbamate
Felbinac
Felodipine
Felypressin
Fenbendazole
Fenethylline
Fenofibrate
Fenofibric Acid
Fenofibric Cholinate
Fenoprofen
Fenoprofen Calcium
Fenoprofen Calcium Dihydrate
Fenoterol HBr
Fenoverine
Fenpiverinium Bromide
Fenretinide
Fenspiride
Fenspiride HCl
Fentanyl
Fentanyl Citrate
Fenticonazole
Fenticonazole Mononitrate
Fenticonazole Nitrate
Ferrous Ammonium Citrate
Ferrous Carboxymaltose
Ferrous Citrate
Ferrous Fumarate
Ferrous Gluconate
Ferrous Sodium Gluconate
Ferrous Sulfate
Ferrous Sulfate Heptahydrate
Fesoterodine
Fesoterodine Fumarate
Fexofenadine
Fexofenadine HCl
Fidaxomicin
Finasteride
Fingolimod
Fingolimod HCl
Firocoxib
Flavours and colours
Flavoxate HCl
Flecainide Acetate
Flecainide Acetate
Fleroxacin
Flibanserin
Flomoxef Sodium
Florfenicol
Florfenicol HCl
Floxuridine
Fluanisone
Flubendazole
Flucloxacillin
Flucloxacillin Magnesium
Flucloxacillin Magnesium Octahydrate
Flucloxacillin Sodium
Fluconazole
Flucytosine
Fludarabine Phosphate
Fludrocortisone
Fludrocortisone Acetate
Flufenamic Acid
Fluindione
Flumazenil
Flumequine
Flumetasone
Flumetasone Pivalate
Flunarizine DiHCl
Flunarizine HCl
Flunisolide
Flunisolide Hemihydrate
Flunitrazepam
Flunixin Meglumine
Fluocinolone Acetonide
Fluocinonide
Fluocortolone
Fluorescein Sodium
Fluorometholone
Fluorometholone Acetate
Fluoxetine
Fluoxetine HCl
Fluoxymesterone
Flupentixol Decanoate
Flupentixol DiHCl
Flupirtine Maleate
Fluprednidene Acetate
Fluprednisolone
Flurandrenolide
Flurazepam DiHCl
Flurazepam HCl
Flurbiprofen
Flurbiprofen Sodium
Flurocitabine
Flutamide
Fluticasone Dipropionate
Fluticasone Furoate
Fluticasone Propionate
Flutrimazole
Fluvastatin
Fluvastatin Sodium
Fluvoxamine Maleate
Folic Acid
Follicle Stimulating Hormone
Fomepizole
Fondaparinux
Fondaparinux Sodium
Formoterol
Formoterol Fumarate
Formoterol Fumarate Dihydrate
Fosamprenavir Calcium
Fosaprepitant
Fosaprepitant Dimeglumine
Fosfomycin
Fosfomycin Calcium
Fosfomycin Phenethylamine
Fosfomycin Sodium
Fosfomycin Trometamol
Fosinopril
Fosinopril Sodium
Fosphenytoin
Fosphenytoin Sodium
Fospropofol
Fotemustine
Framycetin Sulfate
Frovatriptan
Frovatriptan Succinate
Fudosteine
Fulvestrant
Furazidin
Furazolidone
Furosemide
Fusidic Acid

 

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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