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
Octenidine HCl
Octopamine HCl (Norsynephrine HCl)
Octreotide
Octreotide Acetate
Octyl Salicylate
Ofloxacin
Olanzapine
Olanzapine HCl
Oleandomycin
Oleandomycin phosphate
Oleum Hyoscyami
Olmesartan
Olmesartan Cilexetil
Olmesartan Medoxomil
Olopatadine
Olopatadine HCl
Olsalazine Disodium
Olsalazine Sodium
Omeprazole
Omeprazole Magnesium
Omeprazole Sodium
Ondansetron
Ondansetron HCl
Ondansetron HCl Dihydrate
Opipramol DiHCl
Opium
Orciprenaline Sulfate
Orgotein (Superoxide dismutase)
Orlistat
Ornidazole
Orphenadrine
Oseltamivir
Oseltamivir Phosphate
Ospemifene
Oteracil Potassium
Otilonium
Otilonium Bromide
Oxacillin Sodium
Oxacillin Sodium Monohydrate
Oxaliplatin
Oxandrolone
Oxantel Pamoate
Oxaprozin
Oxatomide
Oxatomide Monohydrate
Oxazepam
Oxcarbazepine
Oxetacaine
Oxfendazole
Oxiconazole
Oxiconazole Nitrate
Oxiracetam
Oxolamine
Oxolamine Citrate
Oxolamine Phosphate
Oxomemazine
Oxomemazine HCl
Oxybutynin
Oxybutynin HCl
Oxyclozanide
Oxycodone
Oxycodone HCl
Oxyfedrine HCl
Oxygen
Oxymetazoline
Oxymetazoline HCl
Oxymorphone
Oxymorphone HCl
Oxytetracycline
Oxytetracycline
Oxytetracycline Dihydrate
Oxytetracycline HCl
Oxytocin
Ozagrel
Ozagrel HCl
Ozagrel Sodium

 

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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