Regulatory Affairs

Audits (Pharma GMP Audit Solutions) :-

GMP Compliance | GMP Consultancy Services | GMP Audit Pharmaceutical | GMP Gap Analysis Audit | GMP Training | DMF/Dossier Preparation | cGMP Consulting Services | Quality Management Systems | Technical Document Writing

KNORS Pharma qualified auditors perform third party audits of manufacturers of Drug Products, Active Pharmaceutical Ingredients, Raw Materials, Packing Materials and Intermediates. Our auditors are trained to perform audits as per standards

  1. US 21 CFR 210-211 (cGMP), EU GMP part I and EU GDP for Medicinal products
  2. ISO 13485, US 21CFR 820, EU GMP Part 1 with Annex 10 for Sterile Medical Devices and Medical implantable devices
  3. EU GMP part II for API (ICH Q7) , EU GDP for API, US 21 CFR 210-211 (cGMP) for Active Pharmaceutical Ingredients, Pharmaceutical Intermediates, Pharmaceutical Raw Materials
  4. ISO 22716 for Cosmetic Ingredients
  5. ISO 15378, PS 9000 For Primary packaging for medicinal products
  6. EU IPEC GMP, EU IPEC GDP for Pharmaceutical Excipients
  7. ISO 9001 for Chemical manufacturers

KNORS Pharma Solution auditors have cumulative auditing experience of more than 300 audits. Audit reports of our auditors are accepted across the globe and reviewed during regulatory inspections.