MEDATEQ LABS 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.
Schedule -M
ISO 9001 for Chemical manufacturers
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
ISO 22716 for Cosmetic Ingredients
US 21 CFR 210-211 (cGMP), EU GMP part I and EU GDP for Medicinal products
ISO 13485, US 21CFR 820, EU GMP Part 1 with Annex 10 for Sterile Medical Devices and Medical implantable devices
ISO 15378, PS 9000 For Primary packaging for medicinal products
EU IPEC GMP, EU IPEC GDP for Pharmaceutical Excipients
MEDATEQ LABS auditors have cumulative auditing experience of more than 450+ audits. Audit reports of our auditors are accepted across the globe and reviewed during regulatory inspections.
cGMP Consulting Services
GMP Gap Analysis Audit
GMP Training
DMF/Dossier Preparation
Quality Management Systems
Technical Document Writing
Vendor Audit
Documentation
