- Line clearance "

SOP qa-05-019 .cGMP

- ) Starting-up (
.
- Yield reconciliation "
.
- Control of non conforming product
&identification of status "
.SOP qa-05-037
- ) (received starting materials"
.
- Challenge
" SOP pr-06-001
- " SOP qa-06-002
- ) (incidences &deviations
" SOP qa-03-006
-
.
- Retained samples
.
- "

No. Of tested units
B

: A/B A/B

A/B A/B
=
= A/B
IPC 2016
 A/B =
Machine/process Code No. Frequency No. of Total no. No. of
of tests of tests tested
checking/3 units*
shifts
Groninger filling machine LQ-22 24 3/4 72/96 336
bottles
PAGO insert folding LQ-21 24 1 24 240
inserts
CAM packaging machine LQ-23 24 1 24 240
folding
carton
Manual packaging -------- 8(one shift) 1 8 80
Manual packaging ----------- 8(one shift) 1 8 80
Total no. of tested units: 976units

A/B A/B :

A/B A/B

=
A/B =

A/B =
No. Machine/process Code No. Frequency No. of Total no. No. of Remarks
of tests of tests tested
checking/3 units*
shifts
1 Bausch & Strbel LQ-16 24 3 72 576
bottles
2 IWKA insert folding LQ-19 24 1 24 240inserts
3 CAM packaging machine LQ-20 24 1 24 240
folding
carton
Total no. of tested units: 1056 units

A/B A/B :

A/B A/B
IPC 2016
 =
. + A/B =

Machine/process Code No. Frequency No. of Total no. No. of

of tests of tests tested
checking/2 units*
shifts
KALIX filling OT-04 24 3 64 608 tubes
CAM (4) insert folding Bc-03 16 1 16 160
folding
cartons
CAM (4) Packaging machine Bc-03 16 1 160
inserts
Manual packaging -------- 8 1 8 80 folding
cartons
Total no. of tested units: 1008units

A/B A/B :.

A/B A/B

:.
+ A/B :

Machine/process Code No. Frequency No. of Total no. No. of

of tests of tests tested
checking/2 units*
shifts
IWKA (Filling) Ot-07 24 3 64 608 tubes
IWKA insert folding Ot-08 16 1 16 160inserts
IWKA packaging Ot-08 16 1 16 160
folding
cartons
Total no. of tested unit :928 units

IPC 2016

: A/B A/B

A/B A/B

= A/B

= A/B

Machine/process Code No. Frequency No. of Total no. No. of tested

of tests of tests *units
checking/2
shifts
Sarong filling machine Sp-02 32 3 64 64 strips
)(384
suppositories
Manual packaging -------- 8 1 8 80 folding
cartons
Total no. of tested units: 64 strips+80 folding cartons units

A/B A/B = + +

/
/
/ / / / /

:

:
:.
IPC 2016
Machine/process Code No. Frequency No. of Total no. No. of
of tests of tests tested
checking/2 units*
shifts
Compression Machine TC/10-1 32 4 128 960
tablets
Compression Machine TC/10-2 32 4 128 960
tablets
Compression Machine TC/10-3 32 4 128 960
tablets
Compression Machine TC/10-4 32 4 128 960
tablets
Compression Machine TC/10-5 32 4 128 960
tablets
Coating Machine TC/16-1 2 3 6 100
tablets
Coating Machine TC/16-2 2 3 6 100
tablets
Coating Machine TC/17-1 2 3 6 100
tablets
Capsule Filling TC/11-1 32 2 64 1600
capsules
Capsule Filling TC/11-2 32 2 64 1600
capsules
Capsule Filling TC/11-3 32 2 64 1600
capsules
Inspection Machine(visual) TC/13-1 1 1 1 800
tablets
Inspection Machine(visual) TC/13-2 1 1 1 800
tablets
Inspection Machine(visual) TC/13-3 1 1 1 800
tablets
Total no. of tested units: 12300units

+ + =
/
/
/ / :

IPC 2016
 / :
/ :
/ A/B + :

Machine/process Code No. Frequency No. of Total no. No. of

of tests of tests tested
checking/2 units*
shifts
CAM (1) (Blistering) Bc/02-3 16 2 32 10 blisters
average
CAM (2) (Blistering) Bc/10-2 16 2 32 10 blisters
CAM (3) (Blistering) Bc/11-6 16 2 32 10 blisters
Uhlmann (1) (Blistering) Bc/2-1 16 2 32 10 blisters
Uhlmann (2) (Blistering) Bc/2-2 16 2 32 10 blisters
Counting Room (Tablets &Capsules) Bc/08-1 8 2 16 10
one shift containers
Powder Filling in Sachets Machine (1) (External- Pf/03-1 16 3 32 240
use powder) one shift sachets
Powder Filling in Bottles Machine Pf/02-2 16 3 32 240
one shift bottles

Total no. of tested units: 540units

=
/ / / =
/ A/B + =

IPC 2016
Machine/process Code No. Frequency of No. of Total no. No. of
checking/one tests of tests tested
or 2 shifts units*
Packaging of powder in bottles line BC/13-1 8 1 8 80 folding
cartons
Manual packaging line (A) BC/07-1 8 1 8 80 folding
cartons
Packaging powder in sachets line Pf/04-02 8 1 8 80 folding
cartons
Uhlmann (2) packaging machine BC/01-2 16 1 16 160
folding
cartons
Uhlmann (1) packaging machine BC/01-1 16 1 16 160
folding
cartons
CAM (2) packaging machine BC/10-1 16 1 16 160
folding
cartons
CAM (3) packaging machine BC/11-5 16 1 16 160
folding
cartons
CAM (1) packaging machine BC/01-3 16 1 16 160
folding
cartons
Manual packaging line (B) BC/07-2 8 1 8 80 folding
cartons
Ink-jet machine 9030 9030 8 1 8 80
Ink- jet machine (A300) BC/12-4 8 1 8 80
Ink- jet machine (9040) BC/14-2 8 1 8 80
Folding Inserts Machine BC/04-1 8 1 8 80
BC/13-6 8 1 8 80
BC/13-5 8 1 8 80
Special orders room BC/12-5 8 1 8 80
Shrink Machine (1) BC/06-1 8 1 8 80
Shrink Machine (2) BC/06-3 8 1 8 80
Bottle sticker Machine (PAGO) BC/13-3 8 1 8 80

Total no. of tested units: 1920 units

. =

( ) / + / =
- - / :
/:
IPC 2016
 . / :

No. Machine/process Code No. Frequency No. of Total No. of

of tests no. of tested
checking/2 tests units*
shifts
1 Bosch (Filling) PR/10-3 48 3 96 768
ampoules
2 Pinhole inspector PR/24 1 1 1 500
3 Optrel machine Inspector PR/24-2 1 1 1 500
4 CAM(1) PR/28-1 16 1 16 160
PR/29-1 16 1 16 160
PR/30-1 16 1 16 160
5 CAM(2) PR/28-2 16 1 16 160
PR/29-2 16 1 16 160
PR/30-2 16 1 16 160
6 JAM (Printing) 9030 16 1 16 160
7 IMA (Sticker) PR/25-2 16 1 16 160
8 Manual Packaging Line (1) ---------- 8 1 8 80
9 Manual Packaging Line (2) -------------- 8 1 8 80
Total no. of tested units: 3226 units

:
/ :

No. Machine/process Code Frequency No. of Total No. of

No. of tests no. of tested
checking/ tests units*
shift
1 Filling Machine ER-02 16 5 80 800
Encapsulation machine ER-03 bottles
Injection Machine ER-04
Gas Filling Machine ER-05
2 Leakage Test ER-08 11 1 11 3000
bottles
3 Printing machine Jam 9040 16 1 16 160
3 Manual Packaging line ------- 16 1 160 160
Total no. of tested units: 4120 units

IPC 2016

= .

:
- % -"
- .

IPC 2016