a) Define "manufacture" under the Pharmacy and Poisons Ordinance.

b) Describe the responsibilities of an Authorised Person of a licensed manufacturer as stipulated under the Pharmacy and Poisons Regulatons.

c) Describe FIVE aspects of which a licensed manufacturer must maintain adequate records in respect of each pharmaceutical product prepared and the timeframe for completion for each of these records as stipulated under the Pharmacy and Poisons Regulations.

(20 marks)