Frozen Assets - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Frozen Assets
Even when all is well at the facility, one must expect the worst while braving the elements.


Pharmaceutical Technology
Volume 36, Issue 11, pp. 16

Interruptible power supply

"We are connected to an uninterruptible power supply (UPS)," our GMP Agent-In-Place complained. "When the power went off on our lyophilizer, the UPS should have kicked in immediately. We had $1 million of product in the lyophilizer that was at risk, so the UPS was a good idea. However, on one occasion, the UPS failed to kick in, and as a result of the power outage, the lyophilizer compressors stopped cooling the shelves, and the shelves no longer met the cold temperature requirement. This happened after midnight on a Saturday, so we needed to notify mechanics and experts. It took nearly 13 hours to correct, so we had a deviation of major proportions. We soon replaced the UPS because the existing one was malfunctioning. The batch had to undergo significant laboratory and technical evaluation before being considered for release."

Lack of product stability

"We purchased product from another company," explained our GMP Agent-In-Place. "The product had a room temperature allowance within the usual refrigerated storage requirement. The idea is that the patient could store the product on their counter rather than in a refrigerator. The other company made a change to the stabilizer of the product and their stability studies seemed to show there was no change in product stability. Unfortunately, after we started distribution of the new formula, additional stability data showed the formula would not meet the room temperature allowance and we had to recall several batches. The reason for the delayed information was that the assay for the product was quite variable with a coefficient of variation of 7%. This variability hid the true stability for some time, and we paid the price."

Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the files of Control, a senior compliance officer. If you have a story to share, please email it to Control at

We won't use any names, but if we do use your experience in the column, you'll receive a Pharmaceutical Technology t-shirt.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: Pharmaceutical Technology,
Click here