EQUIPMENT VALIDATION IS NOT PROCESS VALIDATION

Posted on June 11, 2014

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

FDA plans major overhaul, looks to be more specialized

Posted on February 12, 2014

5 months ago the FDA announced that in response to “unparalleled challenges” posed by advances in science, globalization and product complexity, the agency would need to realign its programs. With very little detail it was revealed that it would be led by a Program Alignment Group (PAG) consisting of all executive-level members of each of the FDA’s regulatory centers, as well as the Office of Regulatory Affairs (ORA).

In a memorandum distributed to high...

We do what we do for a reason

Posted on January 08, 2014

There was a talk given at a recent conference by a man named Rick Roberts, who has been a victim of both drug shortages and counterfeit drugs. Mr. Roberts grew up in small town in the US. Due to health problems, he had an inhaler from age one. Because of this, he had many trips to the pharmacy growing up and became very interested in the field, eventually deciding he wanted to be a pharmacist. Mr. Roberts went to college in San Francisco, California, and unfortunately contracted...