Author Archives: Peter H. Calcott

Managing Contract Relationships with Quality Agreements: Keeping in Mind the New FDA Guidance

by

Using contract manufacturing organizations (CMOs) to augment your supply chain is not a new phenomenon in the pharmaceutical industry. One of my first projects in industry involved developing a process for a recombinant protein while manufacturing materials for clinical trials. My team recognized that the company did not have the money to build a plant for manufacturing an unproven product, and it was not bullish to the risk of investing, so we turned to a contract manufacturer in Austria. That…

June 1, 2014

How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 2

by

    Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking questions.   Part 1 of this article described the history of process validation before the FDA’s quality by design (QbD) initiative and discussed QbD in general. It also described the new process validation…

December 1, 2011

How QbD and the FDA Process Validation Guidance Affect Product Development and Operations, Part 1

by

    Earlier this year, the FDA issued its long-awaited process validation guidance document, which had been several years in development. It is well written and effectively articulates what many progressive companies have been thinking and doing for years. But many people in the industry are asking questions: How will it affect our process development programs? How will it affect the submissions and licensure of our products? And how will it aid in our commercial operations? Or will it have…

November 1, 2011