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
R-Baclofen
Rabeprazole Sodium
Racecadotril
Ractopamine
Ractopamine HCl
Rafoxanide
Raloxifene
Raloxifene HCl
Raltegravir
Raltegravir Potassium
Raltitrexed
Ramelteon
Ramipril
Ramosetron HCl
Ranitidine
Ranitidine HCl
Ranolazine
Ranolazine DiHCl
Rapamycin
Rasagiline
Rasagiline Mesylate
Rasagiline Tartrate
Ravuconazole
Rebamipide
Regadenoson
Regadenoson Monohydrate
Regorafenib
Remifentanil HCl
Repaglinide
Reproterol HCl
Reserpine
Residronate Sodium
Retapamulin
Retigabine (Ezogabine)
Revaprazan
Ribavirin
Riboflavin
Riboflavin Sodium Phosphate
Ribonuclease A
Ribostamycin Sulfate
Ridaforolimus
Rifabutin
Rifampicin
Rifamycin
Rifamycin Sodium
Rifapentine
Rifaximin
Rilmenidine Hydrogen Phosphate
Rilmenidine Phosphate
Rilpivirine
Rilpivirine HCl
Riluzole
Rimantadine
Rimantadine HCl
Rimonabant
Riociguat
Risedronate
Risedronate Sodium
Risedronate Sodium Hemipentahydrate
Risperidone
Risperidone HCl
Ristocetin
Ritalinic Acid
Ritodrine
Ritodrine HCl
Ritonavir
Rivaroxaban
Rivastigmine
Rivastigmine Hydrogen Tartrate
Rivastigmine Tartrate
Rizatriptan
Rizatriptan Benzoate
Robenidine HCI
Rocuronium Bromide
Rofecoxib
Roflumilast
Rolapitant
Romidepsin
Ronidazole
Ropinirole
Ropinirole HCl
Ropivacaine HCl
Ropivacaine HCl monohydrate
Ropivacaine Mesylate
Rosiglitazone
Rosiglitazone Maleate
Rosiglitazone Succinate
Rosuvastatin
Rosuvastatin Calcium
Rotigotine
Roxatidine Acetate HCl
Roxithromycin
Rufinamide
Rutoside Trihydrate
Ruxolitinib

 

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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