Quality Assurance and QC Flashcards
Define QC
Refers to processes that can be measured as the CSP is being produced
Define QA
Involves the evaluation of the final preparation and the facility in which it is compounded
Elements of QA program should be:
Observed (watch someone make it)
Inspected (check what they make)
Tested
Things to be measured:
Air quaility
Routine disinfection processes
Donning of PPE
Review of orders and packages of ingredients
Inspection for absence of particulate matter and leakage and thoroughness of labeling
Expectation defined in USP Chapter 797
Supplemented by state regulations
Federally enforceable
Defines minimum levels
Applies to all personnel compounding sterile prep
Three major components in evaluating quality:
Facilities
Personnel
Monitoring (continuously)
Three facets to control of facility:
Design of sterile compounding area
Daily monitoring
Periodic certification
Ante area needs to be what if negative:
ISO 8 (air from buffer area is being blown out) - Hazardous CSPs
Ante area needs to be what if positive:
ISO 7 (don't want to suck in dirtier air into the ante area from the buffer - Non hazardous CSPs
Buffer area has to be:
ISO 7
Daily monitoring has to occur for:
Temperature of clean room, ante area and buffer area (less than 20 degree Celsius)
Airflow patterns
(maybe humidity, light, sound levels but not required)
Primary and secondary controls require:
re-certification at least every 6 months
Primary engineering controls (PECs) include:
HEPA filter integrity
Airflow patterns
Particle counts
Secondary engineering controls include
Non viable: HEPA filter integrity, airflow patterns, air exchanges per hour
Viable: microbial contamination via air sampling
Things cleaned daily
PECs (at the beginning of each shift, before each batch and every 30 minutes), counters, work surfaces and floors
Things cleaned monthly:
Walls, ceilings, storage shelving
Quality plan must document:
Orientation
Training
Ongoing competence
Documentation of training must include:
Completion of didactic instruction Assessment of policies and procedures Written tests Return demonstration Successful completion of: media fill test, gloved fingertip, surface sampling
Media fill involves:
Remove 1 mL from vial and inject into bag, repeat 20 times with new needles
Surface sampling is used to evaluate:
- ability to clean work area
- assurance of proper solutions and dilutions for cleaning
Two ways to ensure freedom from microbial growth:
Periodic surface sampling
Electronic air sampling at least every 6 months
What requires sterility testing:
High risk made in batches of 25 or more
