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
Abacavir
Abacavir Sulfate
Abamectin
Abiraterone
Abiraterone Acetate
Acamprosate
Acamprosate Calcium
Acarbose
Acebutolol
Acebutolol HCl
Aceclidine
Aceclidine HCl
Aceclofenac
Acefylline
Acefylline Piperazine
Acemetacin
Acenocoumarol
Acetaminophen (Paracetamol)
Acetazolamide
Acetyl DL-Leucine
Acetyl hexapeptide-3 (Argireline Acetate)
Acetyl L-Carnitine HCl
Acetyl L-Glutamine
Acetylcyclosporin A
Acetylcysteine
Acetylisovaleryltylosin Tartrate
Acetylsalicylic Acid
Aciclovir
Aciclovir Sodium
Acipimox
Acitretin
Aclidinium Bromide
Acrivastine
Adapalene
Adefovir Dipivoxil
Adenine
Adrenaline
Adrenaline Tartrate
Afloqualone
Afoxolaner
Agomelatine
Alacepril
Alanine
Albendazole
Alcaftadine
Alclometasone Dipropionate
Alendronate Sodium
Alendronate Sodium Trihydrate
Alendronic Acid
Alfacalcidol
Alfadex
Alfatradiol
Alfentanil HCl
Alfuzosin HCl
Algestone Acetophenide
Alibendol
Alimemazine Tartrate
Aliskiren
Aliskiren Fumarate
Aliskiren Hemifumarate
Alitretinoin
Alizapride HCl
Alkyldiamine Ethoxylate
All-Rac-Alpha-Tocopherol
All-Rac-Alpha-Tocopheryl Acetate
Allantoin
Allopurinol
Almotriptan Malate
Almotriptan Maleate
Alogliptin
Alogliptin Benzoate
Aloin
Alosetron
Alosetron HCl
Alovudine
Alpha Ketoglutaric Acid
Alpha-Lipoic Acid
Alpha-Lipoic Acid Carnitine
Alpha-Lipoic Acid Lysinate
Alphamethyldopa
Alprazolam
Alprostadil
Altrenogest
Aluminium Hydroxide
Aluminium Oxide
Aluminium Phosphate
Aluminium Stearate
Alvimopan Dihydrate
Amantadine HCl
Amantadine Sulfate
Ambazone
Ambrisentan
Ambroxol HCl
Ambroxol Theophyllinate
Ambuphylline
Amcinonide
Amfepramone (Diethylpropion)
Amfepramone HCl (Diethylpropion HCl)
Amidotrizoic Acid Dihydrate
Amifostine
Amifostine Trihydrate
Amikacin
Amikacin Sulfate
Amiloride HCl
Amino Acids
Aminocaproic Acid
Aminoglutethimide
Aminophenazone (Amidopyrine)
Aminophylline
Aminophylline Hydrate
Aminopyrine
Aminosidine (Paromomycin)
Amiodarone
Amiodarone HCl
Amisulpride
Amitraz
Amitriptyline
Amitriptyline HCl
Amlexanox
Amlodipine
Amlodipine Besylate
Amlodipine Maleate
Amlodipine Mesylate
Amlodipine Succinate
Ammonium Bituminosulfonate (Ichthammol)
Ammonium Lactate
Amobarbital
Amobarbital Sodium
Amodiaquine
Amodiaquine Dihydrochloride
Amodiaquine HCl
Amorolfine
Amorolfine HCl
Amoxapine
Amoxicillin
Amoxicillin Sodium
Amoxicillin Sodium
Amoxicillin Trihydrate
Ampalex
Amphetamine Aspartate
Amphetamine Sulfate
Amphotericin B
Ampicillin
Ampicillin Sodium
Ampicillin Trihydrate
Ampicillin with Sulbactam
Amprolium
Amprolium HCl
Amrinone (Inanmrinone)
Amrubicin
Amrubicin HCl
Amtolmetin Guacil
Amylmetacresol
Anacetrapib
Anagrelide HCl
Anastrozole
Anidulafungin
Animal Charcoal
Aniracetam
Antazoline
Antazoline HCl
Antazoline Phosphate
Apixaban
Apomorphine HCl
Apomorphine HCl Hemihydrate
Apraclonidine HCl
Apremilast
Aprepitant
Aprotinin
Argatroban
Argatroban Monohydrate
Arginine
Arginine HCl
Argireline Acetate
Aripiprazole
Arsenic Trioxide
Artemether
Artemotil
Artesunate
Artesunate Sodium
Articaine
Articaine HCl (Carticaine HCl)
Asarone
Ascomycin
Ascorbic Acid
Ascorbyl Palmitate
Asenapine
Asenapine Maleate
Asparaginase
Asparagine Monohydrate
Aspartic Acid
Atazanavir
Atazanavir Sulfate
Atenolol
Atipamezole HCl
Atomoxetine
Atomoxetine HCl
Atorvastatin
Atorvastatin Calcium
Atorvastatin Calcium Trihydrate
Atosiban Acetate
Atovaquone
Atracurium Besylate
Atropine
Atropine Sulfate
Auranofin
Avanafil
Axitinib
Azacitidine
Azanidazole
Azapentacene Sodium Polysulfonate
Azaperone
Azasetron
Azatadine Maleate
Azathioprine
Azelastine
Azelastine HCl
Azelnidipine
Azilsartan
Azilsartan Medoxomil
Azilsartan Potassium Medoxomil
Azithromycin
Azithromycin Dihydrate
Azithromycin Monohydrate
Aztreonam

 

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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