BLOOD BANK
Role of Blood
Objectives and Scope
Approach during Inspection
Equipment and Machinery
Procedure and Steps for Licence
Storage Centers
Inspection Report To Be Furnished by FDA Officers
Certificate Of Approval To Blood Storage Centre
Statistical Data


APPROACH DURING INSPECTION OF THE BLOOD BANK :-

The checking of the Blood Bank should be with the following line of aspects.

· Premises.

· Personnel

· Equipment

· Process

· Testing Equipment

· GMP

· SOP

· Calibration

· Sterilization of Reagents.

· Technical factors.

If the unit is Component then every unit of the Components are to be tested according to the standards laid down as per the IP/BP/USP.
Some GMP issues are also to be followed by the Blood Bank unit.


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