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
Bacampicillin HCl
Bacitracin
Bacitracin Zinc
Baclofen
Baclofen Mesylate
Balofloxacin
Balsalazide
Balsalazide Disodium
Balsalazide Disodium Dihydrate
Balsalazide Sodium
Bambuterol
Bambuterol HCl
Bamifylline HCl
Bamipine Lactate
Barbital
Barium Sulfate
Barnidipine
Barnidipine HCl
Bazedoxifene
Bazedoxifene Acetate
Bazedoxifene HCl
Beclometasone
Beclometasone Dipropionate
Belinostat
Benazepril
Benazepril HCl
Bendamustine
Bendamustine HCl
Bendazac Lysine
Bendroflumethiazide
Benfluorex
Benfluorex HCl
Benfotiamine
Benidipine HCl
Benoxinate HCl (Oxybuprocaine HCl)
Benperidol
Benserazide
Benserazide HCl
Benzalkonium Chloride
Benzbromaron
Benzethonium Chloride
Benzocaine
Benzonatate
Benzoyl Peroxide
Benzphetamine
Benzphetamine HCl
Benztropine Mesylate
Benzydamine HCl
Benzyl alcohol
Benzyl benzoate
Benzyl Nicotinate
Benzylpenicillin
Benzylpenicillin Benzathine
Benzylpenicillin Potassium
Benzylpenicillin Procaine
Benzylpenicillin Sodium
Bepotastine Besylate
Bepotastine Nicotinate
Beraprost
Beraprost Sodium
Betacarotene
Betadex
Betahistine
Betahistine DiHCl
Betahistine HCl
Betahistine Mesylate
Betaine Citrate
Betaine HCl
Betaine Monohydrate
Betamethasone
Betamethasone Acetate
Betamethasone Dipropionate
Betamethasone Disodium Phosphate
Betamethasone Sodium Phosphate
Betamethasone Triene
Betamethasone Valerate
Betamethyl Epoxide
Betaxolol HCl
Bethanechol Chloride
Bexarotene
Bezafibrate
Biapenem
Bicalutamide
Bifonazole
Bilastine
Bimatoprost
Biotin
Biperiden HCl
Bisacodyl
Bismuth Subnitrate
Bisoprolol Fumarate
Bisoprolol Hemifumarate
Bisoxatin Acetate
Bivalirudin
Bleomycin Sulfate
Blonanserin
Boceprevir
Borax
Boric Acid
Bortezomib
Bosentan
Bosentan Monohydrate
Bosutinib (Form-I)
Brefeldin A
Bretazenil
Bretylium Tosylate
Brexpiprazole
Brimonidine
Brimonidine Tartrate
Brinzolamide
Brivaracetam
Bromazepam
Bromfenac
Bromfenac Sodium
Bromhexine HCl
Bromocriptine Mesylate
Bromopride
Bromperidol
Bromperidol Decanoate
Brompheniramine Maleate
Bronopol
Brotizolam
Bucillamine
Buclizine HCl
Budesonide
Bufexamac
Buflomedil HCl
Bumetanide
Buparvaquone
Bupivacaine
Bupivacaine HCl
Buprenorphine
Buprenorphine HCl
Bupropion
Bupropion HBr
Bupropion HCl
Buserelin
Buspirone HCl
Busulfan
Butabarbital
Butabarbital Sodium
Butalbital
Butamirate Citrate
Butenafine HCl
Butenafine Nitrate
Butoconazole Nitrate
Butorphanol Tartrate
Butriptyline HCl

 

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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