Drug Product Management

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Discussion Topics
 Facilities
 Equipment
 Documentation
 Investigational Product(s)
 Clinical Samples
 Reference Standards
 Reserve Samples

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Facilities
 Logistics
– Personnel flow
– Receiving
– Work flow
– Waste flow
 Separation of functions

 Adequate Storage
– Temperature controls
– Alerts and alarms
– Backup power

Prevent Cross Contamination

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Equipment
 Specifications
– Approval authority
– Purchasing

 Installation
– Operational ranges
– Alerts and alarms - contacts

 Controlled access
– Software programs/PLCs

 Calibrations and maintenance

– Logs
– Repairs off-site
– Repairs on-site

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Documentation
 Readily retrievable
 Contracts and amendments
 Orders
 Transportation temperature logs
 Logs
 Equipment calibration and maintenance reports
 Inventory
 Training records
 Environmental controls
– Class 100 hoods for preparation of sterile solutions

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Investigational Product(s) – including Controls

 Product receipt
– Container integrity
– Label review
– Shipping temperature review
 Inventory management
– SOPs
– Training
– Reconciliation
– Quarantine and returned goods
 Storage
– Temperature controls
– Light sensitivity
– Stability (storage and use)
 Visual inspection
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Clinical Samples
 Collection
 Labeling
 Handling and processing
– Visual inspection
 Storage and access
 Inventory logs
 Stability
– Temperature
– Light sensitivity
– Opening and closing
– Thawing
– Matrix
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Reference Standards and Stock Solutions

 Procurement
 Preparation of stock solutions
– Expiration dating
– Testing
 Storage and handling
– Mimic sample handling and storage conditions
– Inventory control and access
 Stability
 Documentation

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Reserve Samples

 Investigational Product
– Rational for keeping? All participate
– Per recommended temperature
– Secure location
– Evidence of tampering

 Clinical samples
– Rational for keeping? All participate
– Per SOPs
• Different storage conditions for different types of samples
– Secure location
– Evidence of tampering
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Exercise – Temperature Deviation

 The protocol for the study states that investigational

product should be stored between 25° to 25°C (68 ° to
77°F). Please review the temperature log.

–Are there any deviations?

–If so, what are they?
–How would you remediate any deviations?

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