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Chapter 5 Production (General (Handling of materials & products…
Chapter 5 Production
General
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Containers
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damage
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be investigated, recorded & reported
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At every stage
processing, products & materials
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During processing
materials, bulk containers, major items of equipment & where appropriate rooms used should be labelled
identified with an indication of product @ material being processed (applicable), strength, batch number
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Labels
applied to containers, equipment @ premises
clear, unambiguous & company’s agreed format
use colours to indicate status (quarantined, accepted, rejected, clean)
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Packaging Operations
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Printing operation
correct performance (code numbers, expiry dates)
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Checks be made
to ensure electronic code readers, label counters @ similar devices operate correctly
Set up a programme
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minimise risk of crosscontamination, mix-ups @ substitutions
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Unusual event
be reintroduced into the process after special inspection, investigation & approval by authorised personnel
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Unusual discrepancy
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amount of bulk product & printed packaging materials, the number of units produced
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Roll-feed labels
prefer to cut-labels, to avoid mix-ups
Starting Materials
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Approved supplier
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established by manufacturer, discuss with supplier
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include handling, labelling, packaging requirements, complaints & rejection
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Material delivery
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each batch separate for sampling, testing & release
Label
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status of contents (e.g. in quarantine, on test, released, rejected
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Packaging Materials
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Printed materials
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cut labels, other loose stored & transported in separate closed container (avoid mix-up)
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Rejected, Recovered & Returned Materials
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Returned product
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considered re-sale, re-labelling @ recovery
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nature of product
special storage conditions, history, time elapsed
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