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
N-Acetyl-DL-Methionine
N-Acetyl-L-Cysteine
N-Acetyl-L-Tyrosine
N-Acetylcysteine
Nabumetone
Nadifloxacin
Nadolol
Nafamostat Mesylate
Nafcillin
Nafcillin Sodium
Naftidrofuryl Hydrogen Oxalate
Naftifine HCl
Naftopidil
Naftopidil DiHCl
Nalaxone HCl
Nalbuphine HCl
Nalidixic Acid
Naloxone
Naloxone HCl
Naloxone HCl Dihydrate
Naltrexone
Naltrexone HCl
Naproxen
Naproxen
Naproxen Aminobutanol
Naproxen Sodium
Naratriptan HCl
Nateglinide
Nebivolol
Nebivolol HCl
Nedaplatin
Nefazodone HCl
Nelarabine
Nelfinavir Mesylate
Neomycin Sulfate
Neostigmine Bromide
Neostigmine Methylsulfate
Neotame
Nepafenac
Netilmicin
Netilmicin Sulfate
Netupitant
Nevirapine
Nevirapine Hemihydrate
Niacin (Nicotinic Acid)
Nicametate Citrate
Nicergoline
Niclosamide
Niclosamide Ethanolamine
Niclosamide Monohydrate
Nicorandil
Nicotinamide (Niacinamide)
Nicotine
Nicotine Beta-Cyclodextrin
Nicotine Bitartrate Dihydrate
Nicotine Ditartrate Dihydrate
Nicotine Polacrilex
Nicotine Resinate
Nicotine Salicylate
Nicotine Sulfate
Nicotinic Acid
Nifedipine
Niflumic Acid
Nifuratel
Nifuroxazide
Nigericin
Nilotinib
Nilotinib HCl
Nilotinib HCl Hydrate
Nilutamide
Nimesulide
Nimodipine
Nimorazole
Nimustine HCl
Nisoldipine
Nitazoxanide
Nitisinone
Nitrazepam
Nitrendipine
Nitrofural (Nitrofurazone)
Nitrofurantoin
Nitrogen
Nitroglycerine (Glyceryl Trinitrate)
Nitroscanate
Nitrous Oxide
Nitrovin HCl
Nitroxoline
Nitroxynil
Nizatidine
Nolatrexed DiHCl
Nomegestrol Acetate
Nonoxinol
Noradrenalin Tartrate
Nordoxepin HCl
Norepinephrin HCl (Noradrenaline HCl)
Norepinephrin Tartrate (Noradrenaline Tartrate)
Norepinephrine Bitartrate (Noradrenaline Bitartrate)
Norethindrone
Norethindrone Acetate
Norethisterone
Norethisterone Acetate
Norethisterone Enanthate
Norfenefrine HCl (Norphenylephrine HCl)
Norfloxacin
Norgestimate
Norgestrel
Noroxycodone
Noroxymorphone
Nortriptyline HCl
Noscapine
Noscapine HCl
Novobiocin Sodium
Nystatin

 

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.

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