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
D-Amphetamine
D-Amphetamine Saccharate
D-Amphetamine Sulfate
D-Biotin
Dabigatran Etexilate
Dabigatran Etexilate Mesylate
Dabigatran Etexilate Tartrate
Dabigatran HCl
Dacarbazine
Daclatasvir
Dactinomycin (Actinomycin D)
Dalfopristin
Danazol
Danofloxacin Mesylate
Dantrolene
Dantrolene Sodium
Dantron
Dapagliflozin
Dapoxetine
Dapoxetine HCl
Dapsone
Daptomycin
Darifenacin
Darifenacin HBr
Darunavir
Darunavir Ethanolate
Darunavir Monohydrate
Darunavir N-Propanolate
Dasatinib
Daunorubicin
Daunorubicin HCl
Decitabine
Deferasirox
Deferiprone
Deferoxamine
Deferoxamine Mesylate
Deflazacort
Degarelix Acetate
Delapril HCl
Delaviridine
Delmadinone Acetate
Demeclocycline HCl
Demecolcine
Denbufylline
Deoxycholic Acid
Deoxyribonuclease I
Deprodone
Deprodone Propionate
Dequalinium
Dequalinium Chloride
Deracoxib
Descarbamoylcefuroxime
Desipramine HCl
Desloratadine
Desmopressin
Desmopressin Acetate
Desogestrel
Desonide
Desonide Phosphate
Desoximetasone
Desoxycorticosterone Pivalate (Desoxycortone Pivalate)
Desvenlafaxine
Desvenlafaxine Fumarate
Desvenlafaxine Succinate
Detomidine HCl
DevilÕs Claw Dry Extract
Dexamethasone
Dexamethasone 17-Valerate
Dexamethasone Acetate
Dexamethasone Dipropionate
Dexamethasone Disodium Phosphate
Dexamethasone Isonicotinate
Dexamethasone Sodium Metasulfobenzoate
Dexamethasone Sodium Phosphate
Dexamfetamine Sulfate
Dexbrompheniramine Maleate
Dexchlorpheniramine Tannate
Dexibuprofen
Dexketoprofen Trometamol
Dexlansoprazole
Dexmedetomidine HCl
Dexmethylphenidate HCl
Dexpanthenol
Dexpramipexole
Dexpramipexole DiHCl Monohydrate
Dexrazoxane
Dextran
Dextroamphetamine Saccharate
Dextroamphetamine Sulfate
Dextromethorphan
Dextromethorphan HBr
Dextromethorphan Tannate
Dextropropoxyphene HCl
Dextrose
Diacerein
Diaminazine Diaceturate
Diatrizoate Meglumine
Diatrizoate Sodium
Diatrizoic Acid
Diazepam
Diazepinone N-Oxide
Diazoxide
Dibunafone Disodium
Dibunafone Sodium
Dicaffeine Malate
Dichloralphenazone
Diclazuril
Diclofenac
Diclofenac Diethylamine
Diclofenac Dimethylaminoethanol
Diclofenac Epolamine
Diclofenac Potassium
Diclofenac Resinate
Diclofenac Sodium
Dicloxacillin Sodium
Dicycloverine (Dicyclomine)
Dicycloverine HCl (Dicyclomine HCl)
Didanosine
Dienogest
Diethylamine Salicylate
Diethylcarbamazine Citrate
Diethylpropione Chlorohydrate
Diflorasone
Diflorasone Diacetate
Difloxacin HCl
Diflucortolone Valerate
Diflunisal
Difluprednate
Digitoxin
Digoxin
Dihydralazine Mesylate
Dihydralazine Sulfate
Dihydro Cyclosporin A
Dihydro Cyclosporin C
Dihydro Cyclosporin H
Dihydroartemisinin
Dihydrocodeine Hydrogentartrate
Dihydrocodeine Phosphate
Dihydroergocristine Mesylate
Dihydroergocryptine Mesylate
Dihydroergotamine Mesylate
Dihydroergotoxine Mesylate
Dihydrostreptomycin Sulfate
Dihydrotachysterol
Dihydrotachysterol-2
Dihydroxycholecalciferol
Diiodohydroxyquinoline
Diloxanide Furoate
Diltiazem HCl
Dimenhydrinate
Dimercaprol
Dimercaptosuccinic Acid
Dimethyl Ether
Dimethyl Fumarate
Dimethylamine
Dimethylamino Ethanol
Dimeticone
Dimetindene Maleate
Diminazene Diaceturate
Dinoprost
Dinoprost Tromethamine
Dinoprostone
Diosgenin
Diosmin
Diphenhydramine
Diphenhydramine Citrate
Diphenhydramine HCl
Diphenhydramine Tannate
Diphenoxylate
Diphenoxylate HCl
Diprenorphine
Diprophylline (Dyphylline)
Dipyridamole
Diquafosol Tetrasodium
Dirithromycin
Disopyramide Phosphate
Disulfiram
Dithranol
DL-Dropropizine
DL-Methionine
Dobutamine HCl
Docetaxel
Docetaxel Trihydrate
Docosanol
Docusate Sodium
Dofetilide
Dolasetron Mesylate
Dolutegravir
Domperidone
Domperidone Maleate
Donepezil
Donepezil HCl
Dopamine HCl
Doramectin
Doripenem
Dorzolamide
Dorzolamide HCl
Dosulepin HCl (Dothiepin HCl)
DOTA Base
Doxapram
Doxapram HCl
Doxazosin
Doxazosin Mesylate
Doxepin
Doxepin HCl
Doxercalciferol
Doxifluridine
Doxofylline
Doxorubicin
Doxorubicin HCl
Doxycycline
Doxycycline HCl
Doxycycline Hyclate
Doxycycline Monohydrate
Doxylamine Hydrogen Succinate
Doxylamine Succinate
Dragosantol
Dronedarone
Dronedarone HCl
Droperidol
Dropropizine
Drospirenone
Drotaverine
Drotaverine HCl
Droxidopa
Dry Vitamin E
Duloxetine
Duloxetine HCl
Dutasteride
Dutasteride HCl
Dutogliptin
Dydrogesterone

 

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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