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level: Level 4

Questions and Answers List

Question	Answer
Final drug product without the packaging	Intermediate product
Final drug product with the packaging	Finished product
Current Good Manufacturing Practices for Drugs What Law?	(A.O. 43, Series of 1999)
Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use (WHO, 2007). System of QA aimed at ensuring that products are consistently manufactured to a quality appropriate for their intended use and is concerned with both manufacture and QC processes and procedures (A.O. 43, s. 1999).	Good Manufacturing Practices
Sulfonilamide Elixir tragedy year	1937
US FDA year	1939
Thalidomide tragedy year	1952
GMP year	1956
BFAD year	1974
1 Why is cGMP important? 2 What is the objective of cGMP?	1) 1 To preserve the identity, strength, quality and purity of drugs. 2 To ensure the safety of personnel and patients. 2) 1 Prescribe standard guidelines in the manufacture of drug products. 2 Ensure that no person or establishment shall manufacture drugs under substandard conditions