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
Gabapentin
Gabapentin Enacarbil
Gadobenate Dimeglumine
Gadobutrol
Gadodiamide
Gadopentetic Acid Monomeglumine
Gadoteric Acid
Gadoteridol
Galactose
Galamustine
Galantamine
Galantamine HBr
Galocitabine
Gamma-Aminobutyric Acid (GABA)
Ganciclovir
Ganciclovir Sodium
Ganirelix
Ganirelix Acetate
Gastrodin
Gatifloxacin
Gatifloxacin Hemihydrate
Gatifloxacin Sesquihydrate
Gefitinib
Gefitinib Mesylate
Gelatin
Gemcitabine
Gemcitabine HCl
Gemeprost
Gemfibrozil
Gemfibrozil HCl
Gemifloxacin
Gemifloxacin Mesylate
Gentamicin Sulfate (Gentamycin Sulfate)
Gestodene
Gimeracil
Ginkgo Dry Extract
Glatiramer Acetate
Glibenclamide
Glibornuride
Gliclazide
Glimepiride
Glipizide
Glucosamine HCl
Glucosamine Sulfate Potassium Chloride
Glucosamine Sulfate Sodium Chloride
Glucose
Glucose Monohydrate
Glucose-1-Phospate
Glucose-1-Phosphate Disodium
Glucurolactone
Glutamic Acid
Glutamine
Glycerol (Glycerine)
Glycerophosphorylcholine
Glycerophosphorylethanolamine
Glyceryl Trinitrate
Glycine
Glycopyrrolate
Glycopyrronium Bromide
Glycyl-L Glutamine monohydrate
Glycyl-L-Glutamine
Glycyl-L-Tyrosine
Gold Sodium Thiomalate
Gonadorelin Acetate
Goserelin
Gramicidin
Granisetron
Granisetron HCl
Griseofulvin
Guaifenesin (Glyceryl Guaiacolate)
Guaifenesin Tannate
Guanabenz Acetate
Guanfacine HCl
Guanosine
Guanosine Disodium
Guggulsterone

 

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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