The fundamental process for validation has been in place for 10 years: The pharmaceutical company develops qualifications for a packaging machine, then passes them off to a supplier for equipment designing and manufacturing. After testing and approving the equipment, the pharmaceutical company begins operations.
The Food and Drug Administration made this process at once both easier and more difficult last September with its report "Pharmaceutical cGMP's for the 21st Century – A Risk-Based Approach." Current good manufacturing practices (cGMPs), sometimes known as good automated manufacturing practices (GAMP), have long been a standard practice in the pharmaceutical industry, but new technologies and approaches to quality assurance required more flexibility—and thus more variability—in the validation process.
The cGMP report discusses the integration of more science into the development and deployment of a new product, and it places the onus on pharmaceutical companies to demonstrate an understanding of what can and cannot affect the quality, stability, and efficacy of the product.
"With the FDA's risk-based initiative to cGMPs, the FDA is trying to offer an olive branch to the industry," says Bikash Chatterjee, COO of Pharmatech Associates, a consultancy serving the regulated life sciences industry. "Essentially, the FDA said, 'We're looking for sound science. If you can justify to us that the decisions you have made regarding your critical systems, processes, and equipment are scientifically sound, that's good. Processes are more sophisticated now, and we're trying to rise to meet that challenge.'"
The cGMP guidelines, however, make assumptions that add difficulty to the validation process. For example, the guidelines assume that each system is custom designed, which leads some machinery manufacturers to conclude that the guidelines don't apply to them. As pharmaceutical manufacturers push the issue, more packaging machine manufacturers find themselves being required to provide validation documentation to their customers.
--By Brian Pelletier, Contributing Editor
