The validation related observations that were noted in
warning letter to Nartex Laboratorios Homeopaticos S.A. de C.V. Are below.
1. The firm did not adequately validate the process and qualify the equipment used to manufacture your drug products.
2. They acknowledged that their firm had not performed any process validation or equipment validation for a variety of their homeopathic drug products distributed to the United States.
1. They did not validate supplier COA for appropriate written specifications for purity, strength, and quality.
1. They did not provide details about how they plan to establish the reliability of their supplier’s COA through appropriate validation of the supplier’s test results at appropriate intervals.
These types of areas that were covered in the
“Guide to inspections of dosage form drug manufacturer’s – CGMPs”
