Wednesday, April 20, 2005

Some times despite my attempts not to prejudge people and situations I still do it. Here is what happened in the past three weeks and the cause of all has been miscommunication. In my job I have to write reports everyday and they go through a number of people that have to see that report and sign it. Since it's a very sensitive industry and FDA like a dog is looking at everything, no one likes to give them a reason to be questioned, since answering it would be complicated. Here is the situation.I got a product manufacutred from UK since I am in Quality Control, I have to make sure this drug is really what they say they have made.Now I realized that these drugs failed to meet the criterians and hence can not be released. Now after several people have looked at it, its situation is a mess, Talking to QA's manager, I realized that they have to come up with a reason to stop a formal investigation which can take months. Initially I thought my supervisor is after me to nail me, with her attitude, but talking to QA made more sence. If she had communicated well, our department wouldn't have been having a hectic environment in the past few weeks. At the end of the day, I am just glad that my decision on failing the drugs were the same with the results of a 15 year exprienced person in our department. I hold my self responsible if a patient take a drug that is said to be 200mg +/- 5% to be consuming a 217 mg drug. It has passed the spec. by so much..anyway for peopole not in this business might seem strange, but we talk about small numbers..all the time..and how it affects and all that..it's the nature of pharmaceutical industry:)

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