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Chris Vasquez replied to the topic Discussion Topic: The critical path in the forum Project Management Process and Medical Device Development 8 years, 3 months ago
I had that happen to me when I was working in the consumer sector, I was reforming out of a ester that is now discontinued, it was believed that it was going to be a very simple reform of a popular tanning lotion, we make a batch of the tanning lotion then put it on stability, and it was believed that we were going to have passing results, since it incorporated less the 1 percent of the overall mixture, so as a result the packaging department contacted suppliers and mass produced the new packaging that removed this ester early on in its labeling. A week goes by, while the lotion is in the stability, we notice that the lotion completely failed stability with a complete separation of the emulsion, like I said before it was believed to be a very simple reform and this was not expected, a month later and probably 15 different test batches, we were able to stablize the product for production with the label specific raw materials, if we had not been able the resolve this issue within the month time frame that upper level management gave us, we would have lost alot of money from the packaging alone. Listen learned… ensure that formula is stable before mass producing packaging with specified ingredient list.
Chris