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
Tacrolimus
Tacrolimus Monohydrate
Tadalafil
Tafluprost
Tallimustine Tegafur
Talniflumate
Tamoxifen Citrate
Tamsulosin
Tamsulosin HCl
Tandospirone Citrate
Tapentadol
Tapentadol HCl
Taurolidine
Tauroursodeoxycholic Acid
Tavaborole
Tazarotene
Tazobactam Sodium
Tebipenem Pivoxil
Tedizolid (Torezolid)
Teicoplanin
Telaprevir
Telbivudine
Telithromycin
Telmisartan
Telmisartan HCl
Temazepam
Temozolomide
Temsirolimus
Tenatoprazole
Teneligliptin
Tenofovir
Tenofovir Alafenamide Fumarate
Tenofovir Disoproxil
Tenofovir Disoproxil Fumarate
Tenoxicam
Teprenone
Terazosin
Terazosin HCl
Terazosin HCl Dihydrate
Terazosin hydrochloride dihydrate
Terbinafine
Terbinafine Chlorhydrate
Terbinafine HCl
Terbutaline Sulfate
Terconazole
Terfenadine
Terguride
Teriflunomide
Teriparatide
Teriparatide Acetate
Terizidone
Terlipressin
Terlipressin Acetate
Testosterone
Testosterone Cyclopentyl Proprionate
Testosterone Cypionate
Testosterone Enantate
Testosterone Propionate
Testosterone Undecanoate
Tetanus Toxoid
Tetrabenazine
Tetracaine
Tetracaine HCl
Tetracycline
Tetracycline HCl
Tetramethylpyrazine (Ligustrazine)
Tetrazepam
Tetryzoline HCl (Tetrahydrozoline HCl)
Thalidomide
Thebaine
Thenyldiamine
Theobromine
Theobromine Sodium Salicylate
Theophylline
Theophylline Ethylenediamine
Theophylline Ethylenediamine Hydrate
Theophylline Monohydrate
Theophylline Sodium Glycinate
Thiamazole
Thiamine HCl
Thiamine Mononitrate
Thiamine Nitrate
Thiamphenicol
Thiocolchicoside
Thiopental
Thiopental Sodium
Thioridazine HCl
Thiotepa
Thonzylamine HCl
Threonine
Thrombin
Thymol
Thymopentin
Tiabendazole (Thiabedanzole)
Tiagabine
Tiagabine HCl
Tiamulin
Tiamulin Hydrogen Fumarate
Tianeptine Sodium
Tiapride HCl
Tiaprofenic Acid
Tiaprost
Tiaramide HCl
Tibolone
Ticagrelor
Ticarcillin + Clavulanate
Ticlopidine
Ticlopidine HCl
Tigecycline
Tilidine
Tilidine HCl Hemihydrate
Timolol Hemihydrate
Timolol Maleate
Tinidazole
Tioconazole
Tiopronin
Tiotropium Bromide
Tiotropium Bromide Monohydrate
Tipepidine Citrate
Tirilazad
Tirofiban HCl
Tirofiban HCl Monohydrate
Tiropramide
Tiropramide HCl
Tizanidine
Tizanidine HCl
Tobramycin
Tobramycin Sulfate
Tofacitinib (Tasocitinib)
Tofisopam
Tolazamide
Tolbutamide
Tolcapone
Toldimfos Sodium
Tolfenamic Acid
Tolmetin
Tolmetin Sodium
Tolnaftate
Tolperisone HCl
Tolterodine
Tolterodine Tartrate
Tolvaptan
Topiramate
Topiramate HCl
Topotecan
Topotecan HCl
Torasemide
Toremifene
Toremifene Citrate
Torsemide
Tramadol
Tramadol HCl
Tramazoline HCl Monohydrate
Trandolapril
Tranexamic Acid
Travoprost
Trazodone HCl
Trenbolone Acetate
Trepibutone
Treprostinil Diolamine
Treprostinil Sodium
Tretinoin
Triamcinolone
Triamcinolone Acetonide
Triamcinolone Acetonide Acetate
Triamcinolone Diacetate
Triamcinolone Hexacetonide
Triamcinolone-21-Acetate
Triamterene
Triazolam
Tribenoside
Tricaine Mesylate
Triclabendazole
Triclosan
Trientine
Triethylamine (tea)
Trifluoperazine HCl
Trifluridine
Triflusal
Trihexyphenidyl (Benzhexol)
Trihexyphenidyl HCl (Benzhexol HCl)
Triiodthyronine Sodium (T3, Liothyronine Sodium)
Trilostane
Trimebutine
Trimebutine Maleate
Trimegestone
Trimetazidine
Trimetazidine DiHCl
Trimetazidine HCl
Trimethobenzamide
Trimethobenzamide HCl
Trimethoprim
Trimethylamine (tma)
Trimipramine HCl
Trimipramine Maleate
Trioxsalen
Tripolidine
Tripotassium Dicitrate Bismuthate
Tripotassium Dicitrate Bismuthate Non Ammonia
Triprolidine HCl
Triptorelin
Triptorelin Acetate
Triptorelin Pamoate
Tropicamide
Tropisetron HCl
Trospium Chloride
Troxerutin
Troxipide
Trypsin
Tryptophan
Tulathromycin
Tulobuterol
Tulobuterol HCl
Tylosin
Tylosin Tartrate
Tyrosine
Tyrothricin

 

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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