Which of the following statements are correct regarding the types of studies required to demonstrate the safety and efficacy of line extensions or new dosage forms or strengths of a registered medicine.

Recommend the minimum testing requirements for bisoprolol tablets imported from India, to verify that the product has not been affected adversely during transportation to South Africa.

How many photons of light are emitted when the electrons in 10 hydrogen atoms drop from energy level 4 to 2?

What information must be included in a Tabulated Schedule of Amendments?

Explain the purpose of the conditions specified for Type I variations in the EU Variations Classification.

Your manager provides you with a dossier approved by the Indian FDA (CDSCO) and asks whether it can be used as the basis for a new application for registration based on a reliance pathway to be submitted to SAHPRA.What would your reply be and explain the reasoning for your response.

Which topic is most associated with the understanding the dynamics of decision making?

What do we call inventory held between workstations? Do we want it to be high or low to decrease the effects of variability on our manufacturing process?  Why?

Homer runs a lumber mill and supplies wood planks to a furniture company for assembly into tables. The furniture company requires their suppliers have a defect rate of no more than 66,807 per million planks produced. The planks need to be cut at a length of 4 ft, with a tolerance of plus/minus 0.05 ft. Before Homer starts to mass produce the planks, he runs a pilot test of the process to determine if it is capable of producing fewer defects than allowed. The average plank length is 4.015 ft, with a standard deviation of 0.066.   a) What is the sigma level desired for the process by the furniture company? b) Calculate the Cpk of the pilot test. c) Is the process capable of meeting the sigma level? Show all work to get credit!

What is the main difference we discussed between a Dependent Process and an Independent Process?