Controlled Room Temperature (CRT)/ Cold Chain Challenges and Solutions

Transcription

1 Controlled Room Temperature (CRT)/ Cold Chain Lisa Murray, Janssen Pharmaceuticals, Inc. The content of this presentation are personal views and not necessarily those of Janssen Pharmaceuticals, Inc.

2 Challenges & Solutions An Overview PDMA and Industry Evolution Controlled Room Temperature (CRT) and Cold Room Requirements Defined Considerations in the Logistics Process Warehousing Transportation Storage Compliance Monitoring & Training What s Next Summary 2

3 Controlled Room Temperature (CRT) and Cold Room Requirements Defined - Controlled-room temperature (CRT) - Narrower temperature range than most Rx products - Products safe to store at room temperature - Product handling through a series of processes in a controlled temperature environment - Temperature must be maintained throughout the logistics process ranging between o F - Cold-chain processes - Much stricter temperature requirements - Products must be refrigerated - End to end handling within a specific temperature range using refrigeration at all points in the product handling process 3

4 Controlled Room Temperature (CRT)/Cold Chain Considerations in the logistics process include warehousing, transportation, and storage Storage ongoing temperature monitoring requires clear and specific compliance standards, strong and repe88ve training, as well as monitoring programs Rx Product Only Transporta8on a significant area of risk, product leaves the safety and security of the warehouse environment Careful selec8on of transporta8on methods to ensure product stability is a key component Warehousing systems and processes to monitor product temperature while being warehoused including the process pick and pack process and prepara8on for transport 4

5 An industry program example involving product requiring cold chain processes through representative delivery to the practitioner - Warehousing: - Cold Chain Pick & Pack - Transportation: - Packed in shippers containing ice to ensure consistency of temperature - Hard Styrofoam boxes are used that are packed into cardboard boxes for shipping - Storage - Sales representative stores product in a medical grade refrigerator which is monitored for temperature - An alert is transmitted if temperature goes out of range prompting an investigation - Excursion - Coolers capable of maintaining temperature for a 12 hour period are used to store product during excursion - Gel packs are used and are required to keep frozen when not in use 5

6 Establish Clear Compliance Standards and Requirements - Storage and Refrigeration - Medical grade refrigeration equipment - Temperature monitoring devices measure temperature at predetermined intervals transmitting an alert when temperature has gone out of range - Standard dorm sized refrigerators to be utilized to maintain product temperature - Excursion using coolers with gel packs - Tips - Permit storage of only prescription drug sample products in these refrigerators allowing storage of no other items - Refrigeration should also be labeled as containing Rx products only 6

7 Develop training programs to ensure personnel understand the intricacies of protecting temperature sensitive products - Repetitive - Required periodically - Delivered through various training methods - Methods - Web-based (LMS) which enables documentation of training completions and scores - Compliance reminders and communications - Live, face-to-face 7

8 Monitoring programs ensure product is being handled as required - Monitoring for Non-Compliance - Random and scheduled audits to inspect storage conditions and temperature monitoring - Action plans for inspection failures - Disciplinary action steps where rep non-compliance is identified - Fair and consistent - Retrain 8

9 The future holds new technology ongoing challenges - Temperature indicators - Device alerts when temperature is out of range or has exceeded time out of range - Temperature recorders - Device that electronically records temperature through the logistics process - Temperature is transmitted for immediate alert and analysis - Device alerts when temperature is out of range or has exceeded time out of range - Green box - Innovative DTP shipping method to maintain product temperature - Sustainable - Limited product quantity 9

10 Controlled Room Temperature (CRT)/Cold Chain The future holds ongoing challenges - Varying needs of different products - Cold vs ambient storage requirements - Increase in products with specialized temperature requirements - Balancing challenges between compliance and marketing goals/vision and cost - Continual focus on product quality and sensitivity - Sustainability 10

11 Summary Planning and execution are critical to providing safe delivery of drug samples Weighing marketing plans and goals against financial impact and product safety requirements Elements of a compliant program protecting the safety, efficacy and stability of the drug supply include - Warehousing, Transportation, Storage - Compliance, Training, and Monitoring Future technologies and innovations - easing the achievement of compliance 11

12 Thank You!