Shortcomings in data governance/data integrity and are a prominent feature in drug GMP warning letters over the past three years. FDA inspections also focused on contracted services. Additional areas were the subject of FDA investigator attention in CY2017 but may have been overshadowed by these two. This article explores several of those other areas.
The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.
Consumer awareness of the quality of goods purchased is good practice in any industry, but in biotech and pharma, it is a regulatory requirement. One of the most common goods we purchase in this industry is a vendor’s services — their time, effort, and resources. Whether it be a lab, CRO, or data management group, the FDA mandates we, as sponsor companies, know the quality of the goods and services we purchase from them.
You have struggled with your CMO for the last six months; slowly, but surely, your requested manufacturing dates for your newly transferred process have edged further and further out. You chose this CMO based on several factors: a capability match, good regulatory history, a passing quality systems audit, a capacity match, and their ability to meet your critical and aggressive timelines. Now, the looming reality is that your critical timeline will not be met, and you are struggling to get a believable commitment from the CMO so you can report back to your own organization.
According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we are bound to ensuring all of our equipment is strictly controlled.