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
Haemoglobin Glutamer
Halcinonide
Halobetasol
Halobetasol Propionate
Halometasone
Haloperidol
Haloperidol Decanoate
Halostachine
Heparin Calcium
Heparin Calcium Porcine Origin
Heparin Sodium
Heparin Sodium Porcine Origin
Heptaminol HCl
Herbal Extracts
Hexamidine Diisetionate
Hexetidine
Hexylresorcinol
Histidine
Histidine HCl Monohydrate
Homatropine HBr
Homatropine Methylbromide
Homoharringtonine
Homosalate
Human Chorionic Gonadotropin
Human Menopausal Gonadotropin
Hyaluronidase
Hydralazine
Hydralazine HCl
Hydramethylnon
Hydrochloride Sitapliptine
Hydrochlorothiazide
Hydrocodone
Hydrocodone Bitartrate
Hydrocodone Bitartrate Hydrate
Hydrocodone HCl
Hydrocodone Polistirex
Hydrocortisone
Hydrocortisone 17-Butyrate
Hydrocortisone 17-Valerate
Hydrocortisone Aceponate
Hydrocortisone Acetate
Hydrocortisone Hemisuccinate (Hydrogen Succinate)
Hydrocortisone Sodium Phosphate
Hydrocortisone Sodium Succinate
Hydrogen Peroxide
Hydromorphone
Hydromorphone HCl
Hydroquinone
Hydroxocobalamin Acetate
Hydroxocobalamin Chloride
Hydroxyamphetamine HBr
Hydroxycarbamide (Hydroxyurea)
Hydroxychloroquine
Hydroxychloroquine HCl
Hydroxychloroquine Sulfate
Hydroxyethyl Salicylate
Hydroxyprogesterone Caproate
Hydroxyzine HCl
Hydroxyzine Pamoate
Hymecromone
Hyoscyamine Sulfate
Hypromellose
Hypromellose Phthalate

 

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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