SUPAC

(1) levels of chemistry, manufacturing, and control

change
(2) recommended chemistry, manufacturing, and
controls tests for each level of change
(3) recommended in vitro dissolution and release
tests and/or in vivo bioequivalence tests for each
level of change
(4) recommended documentation that should
support the change for new drug applications and
abbreviated new drug applications.
Immediate or modified release solid oral dosage
forms,
blending, mixing, drying, particle size
reduction/separation, granulation, unit dosage,
coating and printing, and soft gelatin capsule
encapsulation.
Nonsterile semisolid dosage forms,
particle size reduction and/or separation,
mixing, emulsification, deaeration, transfer, and 69
packaging.
IR/MR Information
1. Particle size reduction, ex. Milling
1. Impact (instantanuous force perpendicular), Attrition, Compression (slowly force), Cutting (Shearing froce)

2. Particle Separation
1. Fluid Energy Milling (High speed particle to particle impact, Micronizing),
2. Impact milling (High speed mechanical impact, Milling, pulverizing/comminuting),
3. Cutting (mechanical shearing)
4. Compression milling (compression stress and shear between two surfaces)
5. Screening (Mechanically induced attrition through a screen, milling or deagglomeration)
6. Tumble milling (attrition utilizing grinding media)
7. Separating (screening or bolting)
3. Blend and mixing (uniformity)
1. Diffusion blending (Tumble)
4. 2
5. 2
6. 2
7. 2
8. 2
9. 2
10. 2
11. 2