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
S-Carboxymethylcysteine
S-Carboxymethylcysteine-L-Lysinate
Saccharin Sodium
Sacubitril
Safinamide
Salbutamol (Albuterol)
Salbutamol Sulfate (Albuterol Sulfate)
Salicylamide
Salicylic Acid
Salmcalcitonin
Salmeterol
Salmeterol Xinafoate
Sapropterin DiHCl (Tetrahydrobiopterin DiHCl)
Saquinavir Mesylate
Sarpogrelate
Sarpogrelate HCl
Saw Palmetto extract
Saxagliptin
Saxagliptin HCl
Scopine HCL
Scopolamine (Hyoscine)
Scopolamine Butylbromide (Hyoscine Butylbromide)
Scopolamine HBr (Hyoscine HBr)
Scopolamine Methonitrate (Hyoscine Methonitrate)
Secnidazole
Selamectin
Selegiline
Selegiline HCl
Selenium Sulfide
Selenomethionine
Seletracetam
Selexipag
Sennoside A+B
Serine
Sertaconazole Nitrate
Sertraline
Sertraline HCl
Sesame Oil
Sevelamer Carbonate
Sevelamer HCl
Sevoflurane
Sibutramine HCl
Sildenafil
Sildenafil Citrate
Silodosin
Silver Sulfadiazine
Silver Vitellinate
Silymarin
Simeticone
Simvastatin
Simvastatin with Butylhydroxyanisole
Sirolimus
Sisomicin Sulfate
Sitafloxacin Hydrate
Sitagliptin
Sitagliptin Malate
Sitagliptin Phosphate
Sitagliptin Phosphate Monohydrate
Sitagliptin Sulfate
Sivelestat Sodium Tetrahydrate
Sobrerol (Cyclidrol)
Sodium Acetate Trihydrate
Sodium Ascorbate
Sodium Azide
Sodium Bicarbonate
Sodium Carbonate
Sodium Chloride
Sodium Cholate
Sodium Cromoglicate
Sodium Desoxycholate
Sodium Dichloroacetate
Sodium Fluoride
Sodium Fusidate
Sodium Hyaluronate
Sodium Hydrogen Carbonate
Sodium Lactate
Sodium Methoxide
Sodium Nitroprusside
Sodium Nucleinate
Sodium Oxybate
Sodium Picosulfate
Sodium Salicylate
Sodium Stearate
Sodium Stearyl Fumarate
Sodium Thiomethoxide
Sodium Valproate
Sofosbuvir
Softigen
Solifenacin
Solifenacin Succinate
Somatostatin
Sorafenib
Sorafenib Tosylate
Sorbitol
Sotalol HCl
Soya-Bean Oil
Sparfloxacin
Spectinomycin DiHCl Pentahydrate
Spectinomycin Sulfate Tetrahydrate
Spinosad
Spiramycin
Spiramycin Adipate
Spiramycin Embonate
Spironolactone
St. JohnÕs Wort Dry Extract
Stanozolol
Stavudine
Stearic Acid
Streptomycin Sulfate
Strontium Ranelate
Succinate
Sucralfate
Sufentanil
Sufentanil Base
Sufentanil Citrate
Sugammadex
Sulbactam Sodium
Sulconazole Nitrate
Sulfabenzamide HCl
Sulfacetamide HCl
Sulfacetamide Sodium
Sulfadiazine
Sulfadiazine Sodium
Sulfadimidine (Sulfamethiazine)
Sulfadimidine Sodium (Sulfamethiazine Sodium)
Sulfadoxine
Sulfamethizole
Sulfamethoxazole
Sulfanilamide
Sulfasalazine
Sulfathiazole
Sulfinpyrazone
Sulindac
Sulpiride
Sultamicillin
Sultamicillin Tosilate
Sultamicillin Tosilate Dihydrate
Sultiame
Sumatriptan
Sumatriptan Succinate
Sunitinib
Sunitinib Malate
Superoxide Dismutase
Suplatast Tosilate
Suvorexant
Suxamethonium Chloride (Succinylcholine Chloride)
Suxibuzone
Synephrine (Oxedrine)
Synephrine Tartrate (Oxedrine Tartrate)

 

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!
I agree to the privacy policy. I consent that reports related to products supported by Diapharm may be disclosed to a third party.
X

We are using cookies.

We use third party cookies for usage statistics and to further improve our website.