TGA Audit in pharmaceutical industry l TGA inspection in Pharma company l Question and answers
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Questions covered:
Q. What is TGA audit / TGA inspection?
Q. What are the key details about the Therapeutic Goods Administration (TGA)?
Q. What are key areas reviewed during a TGA audit?
Q. How does the TGA classify audit outcomes ?
Q. How frequently are TGA audits conducted?
Q. What things TGA regulates in the pharmaceutical industry ?
Q. What are the specific GMP guidelines referenced during TGA audits?
Q. What is ARTG in TGA and why it is important?
Q. What is in general scope of TGA audit / inspection ?
Q. What are common TGA inspection types ?
Q. What is TGA GMP certification validity ?
Q. What are regulatory Harmonization for TGA?
Q. What are TGA post-Inspection Actions?
Q. What are the general expectations of auditors during TGA inspections?
Q. What are the consequences of non-compliance in a TGA audit?
Q. What are the latest updates about TGA audit?
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