Logistics:

Logistics:

Paper is to be 6-9 pages, including a one-page executive summary. Margins are to be no more than 1.25” left and right and 1” top and bottom. Spacing is single spaced. Font is no larger than 12 point.

Paper is worth 20% of total class grade, broken down as follows:

Outline of paper) 2%

Rough draft 2%

Outline and draft bonus 1%

documents complete and on time

Final paper

inclusion of major points 6%

correct and appropriate details 6%

writing style 3%

organization, spelling, punctuation, grammar

Assignment:

Dear GMP Consultant,

Allow me to introduce myself. I am your new client, and am the President of Pondell Pharmaceuticals, Ltd. I am planning to build a new pharmaceutical manufacturing plant and need your professional advice. While I know what I want to make, I want to be sure that, when I build the plant, it is compliant with cGMP’s, as defined by the US Food and Drug Administration.

My plant will be making tablets of my new wonder drug, Pondell’s Power Potion (PPP), which cures all diseases. The tablets will be filled into bottles, labeled, and inserted into cartons. The cartons will be put into cardboard shipping containers and sent to wholesale warehouses for distribution. Figure 1 shows a schematic of the operation:

Please prepare and submit a proposal to my company outlining the items and topics that I need to consider assuring that my plant will be constructed and operated per cGMP’s and that I will pass the FDA inspection which will occur prior to commercial introduction of my product. I presume there will be topics on the applicable subchapters from the regulations, to which you will have the appropriate details so that I will know what I need to do. I also expect that you will discuss related topics that have been discussed in your GMP class through the October 25th class period (validation, for example). I do not need for you to write documents for me, but to tell me the types of documents that I will need. I also do not need to have the regulations recited to me (I can read), but for you to tell me which ones would apply and how I might incorporate them to my plant and its design and operation.

To help me present your proposal to my Board of Directors in a clear and concise manner, please prepare a one page Executive Summary as a preface to your main report.

image1

Thank you for your time and consideration. I look forward to your report, and to being able to produce my wonder drug in a safe and compliant manner.

Sincerely,

Steve Pondell

President

Pondell Pharmaceuticals, Ltd.

Figure 1.

Commodities

Excipients

Active Ingredient

Labeling

Make tablets

Fill and label

Package into cartons

Test

Ship

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