FDA: Drugmakers should be hands-on in contractor ops

Expect FDA inspectors to ask drugmakers how they monitor their contract manufacturers. That's according to the FDA's Rick Friedman, paraphrased in the QA Pharm blog.

Recent warning letters have made clear the relationship that the FDA expects between drugmakers and their contractors. Drug companies need to do their up-front work--due diligence audits, quality agreements and supply agreements--but the FDA expects evidence of additional involvement via certain tasks that must not be delegated, says the anonymous columnist.

The FDA inspector must be reassured--reports of GMP audits of contractor facilities must be submitted, for example. Companies should make sure the inspector is aware they have observed their product being manufactured and been hands-on enough to have made the accept/reject decision on final batches of product. The regulator also wants to know drugmakers are monitoring the contractor by tracking product quality data and quality system performance, by approving changes that may affect validated processes, and by approving batch rework and reprocessing.

- read the blog

Suggested Articles

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.

A warning letter says Chinese API maker Yibin Lihao Bio-technical was found lying to the FDA about manufacturing unapproved heparin.

It took four tries over four years, but Perrigo has finally gotten FDA approval of its generic of Teva’s tricky-to-make ProAir HFA asthma inhaler.