Biomedical Engineering Reference
In-Depth Information
ABC PHARMACEUTICAL COMPANY
(TABLET & CAPSULES)
QA IN-PROCESS X & R CHART
PROCESS LIMITS
LEVEL 3
PRODUCT:
PROCESS:
SHAPE / MARKING
TARGET WT.:
mg
SOP NO. QAS - 065/127
BATCH NO:
CODE NO.:
BATCH SIZE:
CAPS SIZE:
UCL:
mg
LCL:
mg
DATE STARTED:
COMPLETED
MACHINE:
CAP:
UCL:
mg
LCL:
mg
OPERATOR:
BODY:
X
-Char
t
Limits
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
+60mg
Date/time
Weight of individual tablet/capsule (mg)
X bar
Range
Barrel No.
+56mg
+52mg
1
+48mg
+44mg
2
+40mg
+36mg
3
+32mg
+28mg
4
+24mg
+20mg
5
+16mg
+12mg
6
+8mg
+4mg
7
8
-4mg
-8mg
-12mg
9
-16mg
-20mg
10
-24mg
-28mg
11
-32mg
-36mg
12
-40mg
-44mg
13
-48mg
-52mg
14
-56mg
-60mg
15
R
-ch
a
rt
Limits
Weight of 10 empty capsules (mg)
Average
Fill wt.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
1
2
3
49
52
45
48
Remarks:
Corrective action:
41
44
37
40
33
36
29
32
25
28
21
24
17
20
13
16
09
12
05
08
01
04
Average weight=
mg
Signature:
QAI
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