SPBK Brochure (SP-BK-B-064T-AA)

Brochure of Neurosanbe® FCT Export to Sri Lanka
Doc. No : SP-BK-B-064T-AA
Pollycelonium
Design code
Material
: BM. 064 – E1
: HVS paper 60 g/m2
SPECIFICATIONS
Test
Description
Dimension
Barmark
Specification
Brochure paper for “NEUROSANBE®” Thiamine
Mononitrate USP, Pyridoxine Hydrochloride USP,
Cyanocobalamin USP Tablet, printed with black color at one
side in English. There are Rx Prescription Drug text.
Length
: 23.5 cm ± 0.2 cm
Width
: 7.0 cm ± 0.2 cm
7.0 cm and 14 cm from bottol-left to above.
Length : 0.4 cm
Width : 0.1 cm
Reference
In House
Specification
In House
Specification
In House
Specification
Weight of paper
60 g/m2 ± 6 g/m2
In House
Specification
Text
Product name, generic name, PT SANBE FARMA :
Clarendon font type
Other text : Avalon font type
Text is explicit and comprehensive as seen on appendices 1.
In House
Specification
Color of text and
barmark
Black
In House
Specification
Physic Testing and
Visual Testing
Printing is neat, clean, unblot, and unpenetrate to the other
side of paper.
Paper cutting is good, neat, and symmetric/precision.
In House
Specification
AQL and defect
criteria
Meet the requirements
In House
Specification
Brochure of Neurosanbe® FCT Export to Sri Lanka
Doc. No : SP-BK-B-064T-AA
METHOD OF ANALYSIS
1. Description
Describe the inspection brochure, record if there are any defect that has been detected.
The description of brochure that has to be inspected are its shape, color, and text
description.
2. Dimension
Measure the length and width of brochure using a ruler.
3. Barmark
Measure the barmark position using a ruler. Describe its lengthm witdth, and position.
4. Weight of Paper
1. Sampling plan
a. Prepare amount of sample as described on ANSI/ASQC Z1.4-1993
b. Cut sample to be tested according to the dimension described as follow:
Sample
Dimension
Replication for each sample
Folding box
20 x 20 mm
10x
Brochure
20 x 20 mm
5x
Label
20 x 20 mm
5x
Polycellonium/polynium
50 x 50 mm
10x
2. Procedure
a. Cut the sample as described at point 1.b
b. Measure the area of the sample to be tested, record.
c. Transfer the sample to the analytical balance using tweezers, measure the weight of
the sample.
d. Repeat the procedure at point 2.a – 2.c until all the sample being measured.
e. Calculate grammage of the sample to be tested
A
G=
a
In which,
G : Grammage of the sample, g/m2
A : Weight of the sample, g
a : Area of the sample, m2
5. Text
Inspect the complement text of brochure. Inspect the font type that has been used. Text
must explicit and comprehensive.
6. Color
Brochure of Neurosanbe® FCT Export to Sri Lanka
Doc. No : SP-BK-B-064T-AA
The color of text and barmark are barmark.
7. Visual testing, Defect Criteria, and AQL (Acceptable Quality Level)
Inspect the physic condition of brochure.
- Observe the brochure, make sure that brochure is easy to fold and easy to insert to its
folding box.
- Observed the brochure, make sure that printing is clear, clean, unblot, and unpenetrate
to the other side of paper.
- Observed the brochure, make sure that paper cutting is good, neat, and
symmetric/precision.
Brochure of Neurosanbe® FCT Export to Sri Lanka
Doc. No : SP-BK-B-064T-AA
SAMPLING PLAN
ANSI/ASQ Z1.4-1993
General Inspection Level II
Sampling the brochure as look as Sampling Standard Table below and make sure that the
process is completely random. Make adjustment about which one is accepted and which
one is rejected based on this table.
Lot or batch size
2-8
9-15
16-25
26-50
51-90
91-150
151-280
281-500
501-1200
1201-3200
3201-10000
10001-35000
35001-150000
150001-500000
500001-over
Critical Defect
0%
N
C
2
0
3
0
5
0
8
0
13
0
20
0
32
0
50
0
80
0
125
0
200
0
315
0
500
0
800
0
1250
0
Note:
N : Total sample
C : Maximum acceptable defect
Critical Defect
AQL : 0%
1. Misprinting, lost text, deleted text
2. Wrong dimension (misplace with other product)
3. Mixed up
4. Version code, supplier logo is wrong or not available
5. Barmark not available or in wrong position
6. Blank text/unprinted/jalf-printed/cropped
Major Defect
AQL : 2.5%
1. Blurred test or shadow (miss register)
2. Dull text (black change to grey)
3. Dimension is out of specification
4. Dirty or black spot clearly visib;e
Major Defect
2.5%
N
C
2
0
3
0
5
0
8
0
13
0
20
1
32
1
50
2
80
5
125
7
200
10
315
14
500
21
800
21
1250
21
Minor Defect
6.5%
N
C
2
0
3
0
5
0
8
1
13
2
20
3
32
5
50
7
80
10
125
14
200
21
315
21
500
21
800
21
1250
21
Brochure of Neurosanbe® FCT Export to Sri Lanka
Doc. No : SP-BK-B-064T-AA
5.
6.
Paper quality is out of specification (paper weight and type)
Barmark hanging (cropped) (± 25%)
Minor Defect
AQL : 6.5%
1. Black spot/stain unclear
2. Some text shadow/result of printed untidy
3. Cropping untidy
4. Cropping imprecise