The layout and design of any pharmaceutical premise is based on four (4) key design objectives. Identify and provide a brief description for each of the four design objectives. (4 marks)

(b) A critical part of premise design is to ensure proper design flow i.e. the logical flow of the process, people and materials (PPMF) in order to minimise/eliminate the risk of error.

(i) It is important to show the status of the materials as they move through the manufacturing process. Explain what you understand by this statement.

(ii) Explain what you understand by the term Process Flow.

(iii) With the aid of a schematic, illustrate how the logical flow (for tablet production) of people and the raw and finished materials can be implemented by the pharmaceutical facilities designer in order to minimize/eliminate risks and avoid problems (the use of colour is essential to your schematic). (15 marks)

(c) What do you understand by the terms FIFO and LIFO in the context of managing raw materials (such as active ingredients, binders etc.) storage and use. Use an example of each to support your answer. (6 marks)

(d) The design of storage and manufacturing areas must protect the product/materials against fluctuations in temperature and moisture Identify five (5) critical requirements you need to consider when controlling temperature and humidity in a pharmaceutical manufacturing facility.

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