Which of the following is a key aspect of the disposition process for reprocessed and reworked materials?Response:

Question

Options

• AAvoiding any quality checks
• BMixing them with new batches without approval
• CApplying appropriate documentation and approval methods
• DStoring them together with active pharmaceutical ingredients

• A
  7% (3)
• B
  4% (2)
• C
  71% (32)
• D
  18% (8)

Explanation

Applying appropriate documentation and approval methods (C) is correct because reprocessed and reworked materials carry inherent risk - they've deviated from the standard manufacturing process, so regulatory frameworks (like FDA 21 CFR and ICH Q7) require formal evaluation, documented justification, and authorized approval before they can be released or used. This ensures traceability and patient safety.

• A is wrong because quality checks are mandatory, not optional - skipping them defeats the entire purpose of GMP oversight and could allow substandard material into the supply chain.
• B is wrong because mixing reworked materials with new batches without approval would contaminate a conforming batch with uncharacterized material, violating batch integrity and traceability requirements.
• D is wrong because storing reworked materials alongside active pharmaceutical ingredients (APIs) risks mix-ups, cross-contamination, and loss of segregation - a fundamental GMP violation.

Memory tip: Think "DAD" - Document, Approve, Dispose. Any material that took a detour through reprocessing or rework must pass through DAD before it goes anywhere near the product stream.

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