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
L-Alanyl-L-Glutamine
L-Arginine-L-Aspartate
L-Aspartic Acid
L-Carnitine Nitrile Hydrochloride
L-Glutamic acid
L-Lysine H2O
L-Lysine Hydrate
L-Methionine
L-Methylcysteine HCl
L-Ornithine-L-Aspartate
L-Phenylalanine
L-Valine
Labetalol HCl
Lacidipine
Lacosamide
Lactic Acid
Lactitol Monohydrate
Lactobionic Acid
Lactulose
Lacydypine
Lafutidine
Lamivudine
Lamotrigine
Lanoconazole
Lanreotide
Lanreotide Acetate
Lansoprazole
Lanthanum Carbonate
Lapatinib
Lapatinib Ditosylate
Latamoxef Sodium
Latanoprost
Leflunomide
Lenalidomide
Lercanidipine
Lercanidipine HCl
Letrozole
Leucine
Leucovorin Calcium
Leuprolide
Leuprorelin Acetate (Leuprolide Acetate)
Levamisole
Levamisole HCl
Levamlodipine Besylate
Levetiracetam
Levobunolol HCl
Levobupivacaine
Levobupivacaine HCl
Levocabastine HCl
Levocetirizine
Levocetirizine DiHCl
Levocetirizine Hemihydrate
Levocloperastine Fendizoate
Levodopa (L-DOPA)
Levodropropizine
Levofloxacin
Levofloxacin Hemihydrate
Levofolinate
Levomenthol
Levomepromazine Maleate
Levomethadone HCl
Levomethamphetamine
Levomilnacipran HCI
Levonordefrine HCl
Levonorgestrel
Levorphanol Tartrate
Levosalbutamol (Levalbuterol)
Levosalbutamol HCl (Levalbuterol HCl)
Levosalbutamol Sulfate (Levalbuterol Sulfate)
Levosalbutamol Tartrate (Levalbuterol Tartrate)
Levosimendan
Levosulpiride
Levothyroxine Sodium (L-Thyroxine Sodium)
Lidamidine HCl
Lidocaine
Lidocaine HCl
Limaprost
Linaclotide
Linagliptin
Linagliptin HCl
Lincomycin HCl
Linezolid
Liraglutide
Lisdexamfetamine
Lisdexamfetamine dimesylate
Lisinopril
Lisinopril Dihydrate
Lisofylline
Lithium Carbonate
Lobaplatin
Lomefloxacin HCl
Lomustine
Lonazolac Calcium
Loperamide
Loperamide HClÊ
Loperamide Oxide Monohydrate
Lopinavir
Loratadine
Loratadine HCl
Lorazepam
Lorcaserine
Lormetazepam
Lornoxicam
Losartan
Losartan Potassium
Loteprednol Etabonate
Lovastatin
Loxapine
Loxapine Succinate
Loxoprofen
Loxoprofen Sodium
Lubiprostone
Lufenuron
Luliconazole
Lumacaftor
Lumefantrine
Lumiracoxib
Lurasidone
Lurasidone HCl
Lymecycline
Lynestrenol
Lysergic Acid
Lysine Acetate
Lysine HCl
Lysine salt

 

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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