Facilities, Equipment
&
Environmental Control
&
Environmental Control
Must dispose of sewage, trash, and other refuse in a timely, safe, and sanitary manner.
What is biohazard?
Tissue from two or more donors must not be placed in physical contact or mixed in a single receptacle during manufacturing.
What is pooling?
Enclosing labels in the processing records as evidence of the actual label used
What is archive?
Conveyance of shipment of an HCT/P that has been approved.
What is distribution?
Detailed “step-by-step” description of HOW we do our work
What is work instruction?
Must be of suitable size, construction, and location.
What is Facility?
ALL materials that are used during manufacture, not just those coming into direct contact with HCT/P’s.
What is supplies & reagents?
Area for stock rooms to prevent mix-ups, contamination, and cross contamination of HCT/P’s, supplies and reagents.
What is storage?
Prevent HCT/P’s being improperly made available for distribution.
What is quarantine?
Your Password
What is electronic signature?
Conditions that could reasonably be expected to cause contamination or cross contamination of HCT/P’s or equipment
What is environmental control?
Examples: Switch from one brand of solution to another, type of antibiotic used in processing, amount of time/ temperature that an HCT/P is exposed to processing reagent, lyophilization cycle recipe.
What is process change?
Each area should indicate the types of supplies, reagents, and HCT/P’s contained in that area, and should be organized to prevent mix-ups, cross contamination, and improper release of HCT/P’s.
What are signs?
HCT/P has been determined to meet all release criteria.
What is available for distribution?
Action to eliminate the cause of a detected non-conformance or other undesirable situation
What is corrective action?
Routine inspection, measuring, and testing according to established procedures and schedules of all automated, mechanical, electronic, or other equipment.
What is calibration/ equipment maintenance?
Identifying receipt of supplies, expiration date, container integrity, lot numbers, and storage is required for supplies and reagents.
What is verification?
Ensuring proper identification of HCT/P’s at every step of manufacturing, procedures must include verification of accuracy, legibility, and integrity.
What is labeling?
HCT/P NOT available for distribution: is in quarantine, is contaminated, incomplete donor eligibility determination, or otherwise does not meet release criteria designed to prevent communicable disease transmission
What is ineligibility?
Action to eliminate the cause of a POTENTIAL non-conformance or other undesirable situation
What is preventive action?
Methods permitting operators to easily check, prior to each use, that the equipment’s maintenance, cleaning, sanitation/ calibration are performed.
What is equipment inspection?
Examples: Removal of blood and lipids from musculoskeletal tissue, through chemical or physical means, chemical/ antibiotics soaks and washes, machined shaping of the bone, irradiation as a terminal sterilization method.
What is processing?
Confirming all extra labels for HCT/P’s.
What is reconciliation?
Before making an HCT/P available for distribution, you must review manufacturing record.
What is release criteria?
What we produce represents the product and evidence that we made it.
What is paperwork?