McGuff Pharmaceuticals Inc Warning Letter 12/28/10 API and Endotoxin

McGuff Pharmaceuticals Inc Warning Letter 12/28/10 API and Endotoxin
CGMP Violations – Barry A Friedman, PhD LLC
2. Your firm has not conducted at least one specific identity test and has not established the reliability of the supplier’s analyses through appropriate validation of the supplier’s results at appropriate intervals [21 C.F.R. §211.84(D)(2)]

For example, your firm accepts and relies upon the Certificate of Analysis (COA) from your active pharmaceutical ingredient (API) suppliers without conducting appropriate validation of the supplier’s results. This is of heightened concern since you have not established endotoxin specification, nor have you performed endotoxin testing on APIs intended to be used in the manufacture of sterile drugs.

In your response, your firm commits to test any APIs with amended specifications in an attempt to correct this deficiency. However, your response fails to explain which specifications are to be amended or which APIs are to be tested. In addition, you do not describe corrective actions regarding products currently in the market manufactured with APIs of questionable quality.

COMMENTS

Firms which purchase Active Pharmaceutical Ingredients (API) from suppliers should assure that the API meet requirements to include identity, strength, quality and purity (21 C.F.R. 211.100). This should also include tests to demonstrate stability (stability indicating test(s)). Such APIs if used as injectable drugs should also contain an endotoxin specification on the Certificate of Analysis (COA) and be demonstrated to comply through in-house testing. Assuming that retained APIs have been maintained or can be obtained through the supplier(s), selected testing of the APIs to include endotoxin may be available to confirm each products’ quality that has been distributed within the market.