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This week, you are the lead of a manufacturing company that designs, manufactures, processes and distributes a medicine that is used for pain relief. This drug is a prescription drug. Explain to the class what your drug is designed to treat – back pain, headaches, post-surgical pain, etc. Then, detail the GMP methods your company uses to ensure compliance by FDA standards. Explain how your company specifically tests the product to verify that it meets specifications and “does what it says it will do”. What controls do you use? In your manufacturing company, you are conducting a routine inspection of the premises. You discover in your inspection the presence of mold in the plastic bottles that are used for the distribution of the drug. You decide to have the remaining bottles destroyed and continue to manufacture the drug. Are you required to report the mold? Was there a change to the approved protocol for sterilization of the plastic bottles? Are you in compliance with your GMP methods after you destroyed the remaining bottles? Was the source of the mold ever identified? Are there methods in place to prevent mold from growing in the plastic bottles in the future? Please support your answers to the scenario. For example, why did you not find the source of the mold? If you did find the source of the mold, what was it and how are you preventing future contamination?

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