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
Macrogol
Magnesium Carbonate
Magnesium Gluconate
Magnesium Hydroxide
Magnesium Lactate
Magnesium Metamizole
Magnesium Oxide
Manidipine Dihydrochloride
Maropitant
Maropitant citrate hydrate
Mass Estarin E.
MDTG Methyl-di(2-thienyl)glycolate
Mebeverine HCl
Medroxyprogesterone Acetate
Medroxyprogesterone Acetate micronized
Mefenamic Acid
Megestrol Acetate
Meldonium (Mildronate)
Meloxicam
Memantine HCl
Menthol
Menthol Levo Pellets
Menthol Racemic
Mepivacain HCl
Mesalazine
Metamizole Sodium
Methadone HCl
Methamphetamine HCl
Methenamine Hippurate
Methionine
Methocarbamol
Methothrexate Disodium
Methotrexate
Methyl Cobalamine
Methyl Salicylate
Methylamine
Methylamino Ethanol
Methylcellulose
Methylcysteine HCl
Methyldopa
Methylene Blue
Methylephedrine HCl
Methylergometrine Maleate (Methylergonovine Maleate)
Methylnaltrexone Bromide
Methylphenidate
Methylphenidate HCl
Methylphenobarbital
Methylprednisolone
Methylprednisolone Aceponate
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate (Hydrogen Succinate)
Methylprednisolone Sodium Succinate
Methyltestosterone
Metipranolol
Metoclopramide
Metoclopramide DiHCl
Metoclopramide HCl
Metolazone
Metoprolol
Metoprolol Succinate
Metoprolol Tartrate
Metronidazole
Metronidazole Benzoate
Mexiletine HCl
Mezlocillin Sodium Sterile
Mianserin HCl
Micafungin
Micafungin Sodium
Miconazole
Miconazole Nitrate
Microcrystalline Hydroxyapatite
Micronomicin Sulfate
Midazolam
Midazolam HCl
Midazolam Maleate
Midodrine HCl
Mifepristone
Miglitol
Miglustat
Miglyol
Milbemycin Oxime
Milk Thistle Dry Extract
Milnacipran
Milnacipran HCl
Milrinone
Minocycline HCl
Minocycline HCl Dihydrate
Minodronic Acid
Minoxidil
Mirabegron
Mirtazapine
Mirtazapine Hemihydrate
Misoprostol
Mitiglinide
Mitiglinide Calcium
Mitiglinide Calcium Monohydrate
Mitomycin
Mitotane
Mitoxantrone DiHCl
Mitoxantrone HCl
Mizolastine
Moclobemide
Modafinil
Moexipril HCl
Molsidomine
Mometasone
Mometasone Furoate
Mometasone Furoate Monohydrate
Montelukast
Montelukast Sodium
Morantel Citrate
Morantel Tartrate
Morniflumate
Morphine HCl
Morphine Sulfate
Mosapride
Mosapride Citrate
Moxidectin
Moxifloxacin
Moxifloxacin HCl
Moxisylyte HCl (Thymoxamine HCl)
Moxonidine
Mucopolysaccharidase
Mucoproteose
Mupirocin
Mupirocin Calcium
Mycophenolate
Mycophenolate Mofetil
Mycophenolate Mofetil HCl
Mycophenolate Sodium
Myramistin
Myrtecaine HCl (Nopoxamine 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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