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
Paclitaxel HCl
Paliperidone
Paliperidone Palmitate
Palonosetron
Palonosetron HCl
Pamabrom
Pamidronate Disodium
Pamidronate Disodium Pentahydrate
Pamidronate Sodium
Pamidronic Acid
Pancuronium Bromide
Panteprazole
Pantethine
Pantoprazole
Pantoprazole Magnesium
Pantoprazole Sodium
Pantoprazole Sodium Sesquihydrate
Papaverine HCl
Paracetamol (Acetaminophen)
Paramethasone Acetate
Pargeverine
Paricalcitol
Paromomycin Sulfate (Aminosidine Sulfate)
Paroxetine
Paroxetine HCl
Paroxetine HCl Hemihydrate
Passion Flower Dry Extract
Patiromer
Patiromer Calcium
Pazopanib
Pazopanib HCl
Pefloxacin
Pefloxacin Mesylate
Pemetrexed
Pemetrexed Disodium
Pemetrexed Disodium Hemipentahydrate
Pemetrexed Sodium
Pemoline
Penciclovir
Penethamate Hydriodide
Penicillamine
Penicillin G Amidase
Penicillin G Potassium
Penicillin V
Penicillin V Potassium
Pentazocine
Pentazocine HCl
Pentetrazol
Pentifylline
Pentobarbital Sodium
Pentostatin
Pentoxifylline
Pentoxyverine
Pentoxyverine Tannate
Peramivir Trihydrate
Pergolide
Pergolide Mesylate
Perindopril
Perindopril Arginine
Perindopril Erbumine
Perindopril Tert-Butylamine
Permethrin
Perphenazine
Pethidine HCl (Meperidine HCl)
Phenazone (Antipyrine)
Phenazopyridine HCl
Phendimetrazine
Phendimetrazine Tartrate
Pheneturide (Phenylethylacetylurea)
Pheniramine Maleate
Phenobarbital
Phenobarbital HCl
Phenobarbital Sodium
Phenoxybenzamine HCl
Phenoxymethylpenicillin Potassium
Phenprocoumon
Phentermine
Phentermine HCl
Phentolamine Mesylate
Phenyl Salicylate
Phenylalanine
Phenylbutazone
Phenylephrine
Phenylephrine Bitartrate
Phenylephrine HCl
Phenylephrine Tannate
Phenytoin
Phenytoin Calcium
Phenytoin Sodium
Phloroglucinol, Anhydrous
Pholcodine
Phosphorylcolamine
Phosphorylethanolamin
Phosphoserine
Phosphothreonine
Phthalhydrazide
Phthalyl Sulfacetamide
Phthalylsulphathiazole
Phytomenadione (Vitamine K1)
Picatif Medicinal EP 40 Activated Carbon
Picolinic Acid
Picotamide
Pilocarpine
Pilocarpine HCl
Pilocarpine Nitrate
Pimecrolimus
Pimephylline
Pimobendan
Pimozide
Pinaverium Bromide
Pindolol
Pioglitazone
Pioglitazone HCl
Pipamperone DiHCl
Pipemidic Acid
Pipemidic Acid Trihydrate
Pipenzolate
Pipenzolate Bromide
Piperacillin
Piperacillin + Tazobactam
Piperacillin + Tazobactam Sodium
Piperacillin Sodium
Piperaquine
Piperaquine Phosphate
Piperazine
Piperazine Adipate
Piperazine Citrate
Piperazine Monohydrate
Piprinhydrinate
Piracetam
Pirenzepine DiHCl
Piretanide
Pirfenidone
Piribedil
Piroxicam
Piroxicam _-Cyclodextrin
Pitavastatin
Pitavastatin Calcium
Pitofenone HCl
Pivampicillin
Pivmecillinam HCl
Pizotifen Malate
Plerixafor
Policresulen
Polidocanol
Polymyxin B Sulfate
Polysorbate 80
Pomalidomide
Posaconazole
Potassium Aspartate
Potassium Chloride
Potassium Citrate
Potassium Clavulanate
Potassium Gluconate
Potassium Guaiacolsulfonate
Potassium Iodide
Potassium Nitrite
Potassium Orotate
Potassium P-Aminobenzoate
Povidone
Povidone Iodide
Pralatrexate
Pralidoxime Chloride
Pramipexole
Pramipexole DiHCl
Pramipexole DiHCl Monohydrate
Pramlintide Acetate
Pramocaine HCl (Pramoxine HCl)
Pranlukast Hemihydrate
Pranlukast Hydrate
Pranoprofen
Prasterone (Dehydroepiandrosterone)
Prasugrel
Prasugrel HCl
Prasugrel Maleate
Pravastatin
Pravastatin Sodium
Prazepam
Praziquantel
Prazosin
Prazosin HCl
Prednicarbate
Prednisolone
Prednisolone Acetate
Prednisolone Disodium Phosphate
Prednisolone Hemisuccinate (Hydrogen Succinate)
Prednisolone Sodium Metasulfobenzoate
Prednisolone Sodium Phosphate
Prednisolone Valerate Acetate
Prednisone
Prednisone Acetate
Prednylidene
Pregabalin
Prenoxdiazine HCl
Pridinol
Pridinol Mesylate
Prifinium Bromide
Prilocaine
Prilocaine HCl
Primidone
Pristinamycin
Probenecid
Probucol
Procainamide HCl
Procyclidine
Procyclidine HCl
Progesterone
Proguanil HCl
Proline
Prolyl-Rapamycin
Promazine HCl
Promethazine
Promethazine HCl
Propacetamol
Propacetamol HCl
Propafenone
Propafenone HCl
Propentofylline
Propiverine HCl
Propofol
Propranolol
Propranolol HCl
Propyl Gallate
Propylthiouracil
Propyphenazone
Prostacyclin (Epoprostenol)
Prostacyclin Sodium (Epoprostenol Sodium)
Protamine Sulfate
Prothionamide
Protirelin (Thyrotropin Releasing Hormone)
Protriptylene HCl
Protriptyline
Proxymetacaine HCl (Proparacaine HCl)
Proxyphylline
Prucalopride Succinate
Pseudoephedrine HCl
Pseudoephedrine Sulfate
Pseudoephedrine Tannate
PVP-Iodine
Pyrantel
Pyrantel Embonate
Pyrantel Pamoate
Pyrantel Tartate
Pyrazinamide
Pyridostigmine Bromide
Pyridoxal 5-Phosphate
Pyridoxine HCl
Pyriglutine
Pyrilamine Tannate
Pyrimethamine
Pyronaridine Tetraphosphate

 

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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