GMP audit reports: Diapharm GmbH & Co. KG

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

File downloads

Most independent 4-way Audit System (2 MB)

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

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

Salutation*
First name*
Last name*
E-mail*
Phone*
Company
Message

Selected entries:

API
Zaltoprofen
Zanamivir
Zidovudine
Zileuton
Zilpaterol HCl
Zinc Gluconate
Zinc Histidine Dihydrate
Zinc Insulin
Zinc Orotate Dihydrate
Zinc Oxide
Zinc Stearate
Zinc Undecylenate
Ziprasidone
Ziprasidone HCl
Ziprasidone HCl Monohydrate
Zofenopril
Zofenopril Calcium
Zoledronic Acid
Zolmitriptan
Zolpidem Hemitartrate
Zolpidem Tartrate
Zolpidic Acid
Zonisamide
Zopiclone
Zotarolimus
Zotepine

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.