DISTRIBUTION CONTROL Flashcards
“the procuring, purchasing, holding, storing, selling, supplying, importing, exporting, or movement of pharmaceutical production” with the exception of the dispensing or providing pharmaceutical products directly to a patient or his her agent.
distribution
Applies to sourcing, storage and transportation of raw materials, packaging materials, and finished products
Distribution Control
That part of quality assurance that ensures that the quality of a pharmaceutical product is maintained
Good Distribution Control
- the management of all phases of the cold chain, including products in transit, in process, in storage, and in display.
- Applicable to temperature sensitive products to ensure product efficacy, safety, and adherence to relevant regulatory requirements
Cold-Chain Management
Pharmaceutical product needing cold chain includes:
vaccines, other biologicals, and selected drugs
It should be suitable for their purpose → to maintain the stability of the product and to prevent contamination of any kind
Vehicles and Equipment
These trucks can handle large quantities of pharmaceutical goods and maintain exact temperature specifications, ranging from room temperature to freezing regardless of the outside temperature.
REEFER TRUCK
are withheld from distribution until batch certification from the FDA is actually received.
antibiotics and Insulin
Companies should acquire respective LTOs from the FDA, e.g. LTO as:
Manufacturer, distributor, wholesaler and retailer
Manufacturer:
Micro and small enterprises
Medium and large enterprises
Cosmetic establishments
Medical device establishments
Drug establishments
- 3 years for initial LTO
- 6 years for renewal LTO
Micro and small enterprises
- 6 years for initial LT
- 12 years for renewal LTO
Medium and large enterprises
1 year
Cosmetic establishments
2 years
Medical device establishments
Drug establishments
three years initially, and can be renewed for five years.
Distributor
two years initially and five years when renewed
Wholesaler
two years initially, and can be renewed for five years.
Retailer
Personnel should have adequate trainings specially those involved in Cold Chain, Hazardous products. Trainings should include:
PPE and personal hygiene.
- is a document that tracks the movement of inventory in a business.
- It records the quantity of goods received and issued, as well as the value of the inventory on hand.
stock card
Stock cards may contain the following:
product
receipts
issues
losses/ad adjustments
closing/ending balance
transaction
should be employed to easily finding faulty products and effectively implement product recall.
tracing system
