Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-007.00 Effective date: mm/dd/yyyy
Approved by:
Corrugation
Small chips
Incomplete coating
Bumpy rough coating
Broken punch marks
Sticking to tablet punch (slight)
26.3.3
a ttriButeS i inSPection: : u ncoated t aBletS
A. Critical defects: AQL 0.0%
Foreign tablets
B. Major defects: AQL 1.0%
Capping
Broken
Picking
Dirty
Large specks
C. Minor defects: AQL 2.5%
Small specks
Porous surface
26.3.4
d efinition of d efectS r elated to c oated t aBletS
A. Critical defects
Foreign tablets: any tablet other than the actual product.
B. Major defects
Broken
: Complete breaking of tablets into two or more pieces.
Chipped
: Removal of part of coating, i.e., core is visible.
Capped
: A tablet showing separation of a part of it and the core of tablet becomes
visible. Such a tablet may or may not break into two parts when shaken in
the loose covered palm of hands.
Sticking
: Tablets stick together in such a way that if separated they may break and
the core becomes visible.
Blistered
: A thin or thick bubble on the surface of tablets due to bulging of the
coated solution.
Color
: The color of the coating not meeting the accepted variation of color.
Sample variation limit indicates tolerance.
Incomplete
coating
: Core visible partly at places due to inadequate coat level.
C. Minor defects
Small specks
: Small visible foreign material on surface.
Corrugation
: Unevenly applied coating, having a wavy or lumpy appearance. Sample
limit indicates tolerance.
Small chips
: Removal of part of tablet and core is not visible.
Incomplete
: Subcoat visible at places particularly at the edges due to inadequate coat
coating
level.
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