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QUESTION
(a) Medicines are much specialised form of consumer product. They must be safe, effective and suitable for their intended purpose. Quality Assurance (QA) in pharmaceuticals is not just an excellent business tool but a legal requirement.
(i) Discuss on the needs for a Quality Assurance system
(ii) How does QA provide objective evidence of Quality?
(b) List and discuss the five key principles of Total Quality Management
(c) Distinguish between Deming's common and special causes of variation and give ONE example of EACH type from your experiences.
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