Quality Assurance and QC

Question 1

Define QC

Answer 1

Refers to processes that can be measured as the CSP is being produced

Question 2

Define QA

Answer 2

Involves the evaluation of the final preparation and the facility in which it is compounded

Question 3

Elements of QA program should be:

Answer 3

Observed (watch someone make it)
Inspected (check what they make)
Tested

Question 4

Things to be measured:

Answer 4

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

Question 5

Expectation defined in USP Chapter 797

Answer 5

Supplemented by state regulations
Federally enforceable
Defines minimum levels
Applies to all personnel compounding sterile prep

Question 6

Three major components in evaluating quality:

Answer 6

Facilities
Personnel
Monitoring (continuously)

Question 7

Three facets to control of facility:

Answer 7

Design of sterile compounding area
Daily monitoring
Periodic certification

Question 8

Ante area needs to be what if negative:

Answer 8

ISO 8 (air from buffer area is being blown out)
- Hazardous CSPs

Question 9

Ante area needs to be what if positive:

Answer 9

ISO 7 (don't want to suck in dirtier air into the ante area from the buffer
- Non hazardous CSPs

Question 10

Buffer area has to be:

Answer 10

ISO 7

Question 11

Daily monitoring has to occur for:

Answer 11

Temperature of clean room, ante area and buffer area (less than 20 degree Celsius)
Airflow patterns
(maybe humidity, light, sound levels but not required)

Question 12

Primary and secondary controls require:

Answer 12

re-certification at least every 6 months

Question 13

Primary engineering controls (PECs) include:

Answer 13

HEPA filter integrity
Airflow patterns
Particle counts

Question 14

Secondary engineering controls include

Answer 14

Non viable: HEPA filter integrity, airflow patterns, air exchanges per hour
Viable: microbial contamination via air sampling

Question 15

Things cleaned daily

Answer 15

PECs (at the beginning of each shift, before each batch and every 30 minutes), counters, work surfaces and floors

Question 16

Things cleaned monthly:

Answer 16

Walls, ceilings, storage shelving

Question 17

Quality plan must document:

Answer 17

Orientation
Training
Ongoing competence

Question 18

Documentation of training must include:

Answer 18

Completion of didactic instruction
Assessment of policies and procedures
Written tests
Return demonstration 
Successful completion of: media fill test, gloved fingertip, surface sampling

Question 19

Media fill involves:

Answer 19

Remove 1 mL from vial and inject into bag, repeat 20 times with new needles

Question 20

Surface sampling is used to evaluate:

Answer 20

• ability to clean work area

- assurance of proper solutions and dilutions for cleaning

Question 21

Two ways to ensure freedom from microbial growth:

Answer 21

Periodic surface sampling

Electronic air sampling at least every 6 months

Question 22

What requires sterility testing:

Answer 22

High risk made in batches of 25 or more