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
Valaciclovir HCl
Valdecoxib
Valerian Dry Aqueous Extract
Valerian Dry Hydroalcoholic Extract
Valganciclovir
Valganciclovir HCl
Valine
Valnemulin
Valproate
Valpromide
Valsartan
Vancomycin
Vancomycin HCl
Vandetanib
Vardenafil
Vardenafil HCl
Varenicline
Varenicline HCl
Varenicline Tartrate
Vasopressin
Vecuronium Bromide
Vemurafenib
Venlafaxine
Venlafaxine Chlorhydrate
Venlafaxine HCl
Verapamil
Verapamil HCl
Vidarabine Monohydrate
Vidarabine Monophosphate
Vigabatrin
Vilanterol Trifenatate
Vilazodone
Vilazodone HCl
Vildagliptin
Vinblastine Sulfate
Vincamine
Vincamone (Eburnamonine)
Vincristine Sulfate
Vindesine
Vinorelbine
Vinorelbine Ditartrate
Vinorelbine Tartrate
Vinpocetine
Vitamin A Acetate
Vitamin A Palmitate
Vitamin B1
Vitamin B12
Vitamin B15
Vitamin B17
Vitamin B2
Vitamin B2
Vitamin B3
Vitamin B4
Vitamin B5
Vitamin B6
Vitamin B6 Dipalmitate
Vitamin B6 Tripalmitate
Vitamin B9
Vitamin C
Vitamin D3
Vitamin D3 crude
Vitamin D3 crystalline
Vitamin E
Vitamin H
Vitamin K1
Vitamin K2
Vitamin K3
Vitamin K4
Voglibose
Voriconazole
Vorinostat
Vortioxetine HBr

 

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!
I agree to the privacy policy. I consent that reports related to products supported by Diapharm may be disclosed to a third party.
X

We are using cookies.

We use third party cookies for usage statistics and to further improve our website.