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
Ibandronate Sodium
Ibrutinib
Ibudilast
Ibuprofen
Ibuprofen Lysinate
Ibuprofen Sodium Dihydrate
Ibutamoren
Ibutilide Fumarate
Icatibant
Icatibant Acetate
Idarubicin
Idarubicin HCl
Idebenone
Idoxuridine
Ifenprodil Tartrate
Ifosfamide
Iloperidone
Iloprost
Imatinib
Imatinib Mesylate
Imidacloprid
Imidapril HCl
Imipenem
Imipenem Monohydrate
Imipenem with Cilastatin
Imipenem with Cilastatin Sodium
Imipramine
Imipramine HCl
Imipramine Pamoate
Imiquimod
Indacaterol
Indapamide
Indinavir Sulfate
Indobufen
Indometacin (Indomethacin)
Indometacin Sodium (Indomethacin Sodium)
Ingenol Mebutate
Inosine
Inosine Disodium Salt
Inositol
Insulin, Bovine
Iobitridol
Iodochlorohydroxyquinoline
Iohexol
Iopamidol
Iopromide
Ipratropium Bromide
Ipriflavone
Irbesartan
Irinotecan
Irinotecan HCl
Irinotecan HCl Trihydrate
Iron Dextran
Iron Sucrose
Irsogladine Maleate
Isocarboxazid
Isoconazole
Isoconazole Nitrate
Isoflupredone Acetate
Isoflurane
Isoleucine
Isometheptene
Isometheptene Mucate
Isoniazid
Isonixine
Isoprenaline (Isoproterenol HCl)
Isoprenaline Sulfate
Isopropyl Alcohol
Isopropylmethylphenol (ipmp)
Isosorbide Dinitrate
Isosorbide Mononitrate
Isosorbide Nitrate
Isosulfan Blue
Isotretinoin
Isotretinoin M
Isoxsuprine HCl
Isradipine
Itopride
Itopride HCl
Itraconazole
Ivabradine
Ivabradine HCl
Ivacaftor
Ivermectin
Ivy Leaf extract
Ixabepilone
Ixazomib

 

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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