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Observations concerning process validation, equipment qualification and maintenance, deviations, customer complaints and training.
Observations concerning environmental monitoring, sterilization validation, gowning procedures.
Observations concerning quality, testing, manufacturing, packaging, document control.
Observations concerning method validation, calibration and preventative maintenance for instruments, sample preparation and reserve samples.
Observations concerning label controls, label issuance, packaging verification.
Observations concerning quality systems, performance qualification, purchasing, supplier verification and CAPA.
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