Abstract

AN OVERVIEW ON “QUALITY AGREEMENT” BETWEEN MANUFACTURER & CUSTOMER

Chinkal Patel and Dr. Dilip Maheshwari*

ABSTRACT

The API is one of the prime components of the drug. Active Pharmaceutical Ingredients (API) of good quality is core to the Manufacturing of effective and safe essential drugs. Only a limited number of large manufacturers of finished pharmaceutical products have their own API manufacturing capabilities, and none of them can make all required APIs in-house. The author confirms the initial assumption that the API market provides a challenge in particular to small manufacturers, who have limited means to verify the quality of the APIs they are buying. APIC’s target is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relating to APIs and intermediates. APIC established of a Quality Agreement between an API manufacturer and its customer. API Suppliers it is essential to ensure high quality of the substances. Thus, a major element of such a supplier qualification program is the “Quality Agreement” between the manufacturer of the API /intermediate and the buyer or user of the API /intermediate.

Keywords: API, Quality, APIC, Agreement.