Quality Control

Question 1

What are the 3 major areas of quality control?

Answer 1

1. Raw materials control
2. In process controls
3. Finished product controls

Question 2

Goal of raw materials control? %purity?

Answer 2

To minimize batch-batch variations

97% purity
Tylenol (98-101%)

Question 3

Goal of in process controls. Regulation?

Answer 3

Quality of manufacturing process
- much more restrictive than final product standards (to provide early warning)
- Not regulated by official compendium standards

Question 4

What are the types of controls in in process controls? (5)

Answer 4

1. Environmental controls (depend on use of dosage form)
2. Working formula procedures (documentation)
3. Equipment control (cleaning, calibration, maintenance)
4. Packing material controls (protect from environment, compatible with drug product, non-toxic)
5. Labelling controls (MUST be documented)

Question 5

Goal of finished product controls

Answer 5

Test every batch to ensure identity, quality, potency, and purity

Question 6

Characteristics of packing materials
Primary vs. Secondary containers

Answer 6

Primary: direct contact with the product (bottle)
Secondary: enclose the primary container (eg. carton box)

Question 7

Are tubes or jars better to minimize microbial contamination

Answer 7

Tubes

Question 8

Advantages and Disadvantages of Glass

Answer 8

Advantages:
- Impermeable to all gass
- Clear
- Easy to clean
- Lots of shapes
- Can be stacked

Disadvantages
- heavy
- fragile
- cost

Question 9

What are the 3 glass packing types (in order of reactivity

Answer 9

Type 1: (borosilicate or neutral)
- parenteral/non-parenteral
- Inert, expensive

Type 2: (de-alkalized or treated soda-lime)
- More reactive
- Acidic/neutral parenterals/ non-parenterals (<pH 7)

Type 3: Soda-lime
- Reactive
- NOT for aqueous parenterals
- For non-parenterals + non-aqueous parenterals

Question 10

Advantages and disadvantages of metal

Answer 10

Adv
- Strong
- shatter proof
- light
- tamper evidence

Disadv
- reactive
- corrosion

Question 11

Adv and disadv of plastics

Answer 11

Adv
- light
- shapes
- shatter proof
- clear/opaque options

Disasdv
- permeable to gas/liquid
- leaking of plastic into product
- loss of drug to plastic (sorption)

Question 12

Types of plastic

Answer 12

See one note

Question 13

Adv and disadv of rubber

Answer 13

Adv
- low fragmentation tendency

Disadv
- permeable to gas/liquid
- sorption (drug going into plastic)