Transcript Labeling and Marketing

Regulatory
Labeling and Marketing
Which ones are involved in label
design and control?
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Manufacturing
Quality Assurance
Quality Control
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Chemistry
Microbiology
Inspection
Regulatory
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Audits
Clinical Trials
FDA filings
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Materials Management
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Receiving
Distribution
Inventory Control
Human Resources
Finance
Sales and Marketing
Management
Research and
Development
Label Design
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All departments who have developed or
will have to manufacture and release the
product will be involved in label design
Label Approval and Control
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Regulatory, Quality Assurance and
Marketing are the groups who “approve”
the final label
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Materials, QA, QC, and Mfg. “control” the
label from receipt, through inspection to
application to product, through finished
product inspection.
Labeling and Packaging Control
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Why would this be an area to be audited?
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Label text: pre-approved and inspected
Label adhesion: pre-approved and inspected
Label accountability: verified at every step
Package insert content: pre-approved and
inspected
Package insert accountability: verified at every
step
CONTROLLED TO PREVENT MIXUPS
Label Text
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Fixed Text
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Text that does not change with each lot
Company name, address,
 Product Name, storage temp, ingredients
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Variable Text
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Text that does change with each lot
Lot number and or serial number
 Expiration Date
 Concentration or Potency
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Marketing Information
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Labels and Package inserts are highly
controlled
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Marketing information such as product
informational flyer
Approved by Regulatory and Marketing
 Marketing distributes w/out control
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