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“Which version of the PIC/S code of GMP is the current version in Australia?”
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Tick all that apply
The principle of Quality Management is to ensure product:
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True or False?
It is ok to not perform root cause analysis for deviations, suspected product defects and other problems if it is clear what the root cause is.
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True or False?
“Senior Management has the ultimate responsibility for the PQS”
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“Suitable controls should be implemented to ensure the accuracy, ______, availability and legibility of documents. Instruction documents should be free from errors and available in writing”
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“ALCOA” stands for _______, Legible, Contemporaneous, Original and ______.
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“Cross contamination should be avoided by robust design of the premises, equipment and processes which take place within a manufacturing facility.”
True or False?
Product Quality reviews should be conducted at least yearly but there are exceptions to this rule
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“As a Contract ______, you do not delegate your regulatory responsibilities.”
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True or False?
“A designated person must be responsible for handling the complaints and deciding the appropriate measures.”
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