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The sampling of packaging material

It is established to provide the guidelines for the sampling of packaging material.


2. SCOPE
It is applicable to all types of incoming material.
3. RESPONSIBILITY
1. Quality Assurance Manager
2. Quality Assurance Officer
4. PROCEDUR
1. Upon receipt of packaging material the warehouse Incharge will issue a respective goods
receiving report, by which the quality assurance department will be requested to collect samples
for analysis and retaining samples. The ware house Incharge will also affix packaging material
identification slip with all necessary information on each container of the same lot together with
a quarantine label, data of sampling, name of person and signature.
2. Before sampling the following points should be checked:
3. During sampling the quality assurance personnel will give all details of the quarantine label
regarding date of sampling name of person and signature.
a) Packing materials are placed in the Quarantine Area, properly labeled.
b) Condition of the container – it should not be damaged, torn, contaminated with dust, water etc.
c) In case of any abnormalities, all details should be noted on packing material receiving receipt.
d) Each uniform looking delivery of packaging materials is considered as one batch.
e) Primary packaging materials are to be considered equivalent to raw materials as far as Quality
is concerned.
4. In case of an already marketed drug product a new primary packing material which is not
stated in the respective GLOBEL packing requisition is supposed to be used, a sufficient amount
of samples have to be sent to QC for compatibility testing before use. Only after QC have given
their consent, this new primary packaging material may be used.
5. Sampling plan should be carried out according to MIL-STD-105D (Table 1 and 2).
6. Knowing the lot size and inspection level, obtain a code letter from table 1.
7. General Inspection Level l = Relaxed
General Inspection Level ll = Normal
General Inspection Level lll = Tightened
8. The delivery is checked according to the GLOBAL Testing standard and has to comply with
the quality requirements stated therein (full analysis).
9. After analysis, released label or rejected label, whichever is applicable, should be placed on
the quarantine label and the material should be placed in the respective area.
SAMPLING PLAN FOR PACKAGING MATERIALS

TABLE 1
SAMPLE SIZE CODE LETTERS
LOT OR BATCH SIZE GENERAL INSPECTION LEVELS
I II III
2 TO 8 A A B
9 TO 15 A B C
16 TO 25 B C D
26 TO 50 C D E
51 TO 90 C E F
91 TO 150 D F G
151 TO 280 E G H
281 TO 500 F H J
501 TO 1200 G J K
1201 TO 3200 H K L
3201 TO 10000 J L M
10001 TO 35000 K M N
35001 TO 150000 L N P
150001 TO 500000 M P Q
500001 AND OVER N Q R
Table ll
SAMPLING PLANS (Normal Inspection)
Sample size code letter Sample size
A
B
C2
3
5
D
E
F8
13
20
G
H
J 32
50
80

K
L
M 125
200
315
N
P
Q 500
800
1250

R
2000
. QUALITY RECORD(s)/FORM(s)

Required Record Form Reference No.


Request for analysis (Packing material) QF/112/01
Raw Material Receiving Receipt QF/012/01
Sampled QF/059/01
Under Test QF/057/02
Quarantined QF/083/01