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Quality Control and Quality Assurance Questions with Correct Answer1
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Quality Control and Quality Assurance Questionswith Correct Answers
Robust Quality System Correct Answer-Procedures are in place and the
company is following the procedures, testing according to the
procedures, and meeting all the specification within procedures.
Quality Management Goals Correct Answer-• control the sources of
product quality variation
• ensure the correct and most appropriate manufacturing and packaging
practices are being followed
• assure that the testing results comply with the standards or
specifications
• assure product stability for products in the market place
QC (quality control) Correct Answer-Part of the quality management
system focused on fulfilling quality requirements.
QC (quality control) Correct Answer-Confirmation in verification aspect
of quality management.
Test products to make sure that they meet specifications.
Set of activities for ensuring quality in products. The activities
CONFIRM that attributes as stated for the product are met.
, o If the attributes are not met, then activities focus on identifying defects
in the actual products produced (BEFORE products is released to the
market place).
Reactive process.
QC responsibilities Correct Answer-Responsible for the day-to-day
control of quality within the company
Responsible for analytical testing of incoming raw materials and
inspection of packaging components, including labelling
Conducts in-process testing when required, perform environmental
monitoring, and conduct the required tests on finished dosage forms
Assists in the selection of qualified vendors from whom raw materials
are purchased. Testing of representative samples is required, and in
many cases, an audit of vendor's operations is necessary to determine
their suitability and degree of compliance with GMPs prior to supplier
approval.
The environmental areas for manufacturing of various dosage forms are
tested and inspected by this division.
QA (quality assurance) Correct Answer-Part of the quality management
system focused on providing confidence that the quality requirements
will be fulfilled.
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