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Clinical Supplies Facility Setup
ClinChain is dedicated to
providing flexible array of services to meet each client’s needs. Below is a
partial list of items required to implement a new clinical supply unit:
- The facility must meet
cGMP guidelines, including design, utilities, plumbing, air/circulation,
security, and pest control.
- Select and successfully
qualify facilities monitoring systems (e.g. temperature/humidity control,
back up generators, etc.).
- Select and validate
software systems.
- Write SOPs to meet cGMP
guidelines.
- Select vendors and
perform cGMP audits.
- Ensure all personnel
have the appropriate education, experience, and training.
In addition, the facilities may need to support multiple activities,
including,
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Manufacturing |
Stability Chambers |
Inventory Management |
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Primary Packaging |
Secondary Packaging |
Labeling |
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Distribution |
Returns/Reconciliation |
Destruction |
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Auxiliary Supplies |
Differential Weight
Reports |
Warehouse Management |
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Long Term Storage |
Archival of
Documentation |
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We will work with you to define exactly what is
needed.
Contact
us for more information about our Clinical Supply
Facilities Setup Services.
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Services
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