Humanwell Pharmaceutical Ethiopia PLC

Form No.: SOP/SL /015/F/01

QA Responsibilities in Injectable Area inspection Form

Attachment (A)
Inspection Start-Up Check List

Issued date: mm/dd/yyyy

Revision no.:
Date:
Room/Area/Line:
Machine/Line:
Product to start:
Batch no.:
Code no.:
Expiry date:
Previous product:
Batch no.:
1. Differential pressure between room and corridor as required ( )
2. Room/area/line is clean ( )
3. Machine/line is clean ( )
4. No materials left from previous product or batch ( )
5. No documents left from previous product or batch ( )
6. Materials/bulk product to be used: ( )
a) Available ( )
b) Complete ( )
c) Released by QC ( )
d) Compared to planning requisition and found same ( )
Remarks

_________________________________________________________________
Batch is released to start by:
Signature and Date
Attachment (B)
Issued date: mm/dd/yyyy
Revision no.:
Date: _________________
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Quality Assurance Department

Release
(Manufacturing)
Product:
Code no.:_________________ Batch no.:
Area: _____________________ Machine:
Process:
Date:
Signature:

Attachment (C)
Issued date: mm/dd/yyyy
Revision no.:
Date: ________

Quality Assurance Department

Release
(Packaging)
Product:
Code no.: _______________ Batch no.:
Line no.: ________________ Consignee:
MFG. date: ______________ Expiry date:
Date:
Signature:

Attachment (D) SOP No.:

AREA/EQUIPMENT CLEARANCE Issued on: mm/dd/yyyy
PRODUCTION Revision No: New
___All related SOPs followed Product for which line
___No traces of previous product clearance required
___Equipment/area cleaned per SOPs Product name:
___Correct material of product for which area Batch no.:
equipment/clearance required
Previous Product Present
Process:
Equipment/room no.:
Previous Time:
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

product:
Batch no.: Date:

Date: Requested by:

Cleared by: Checked by: Checked by:

Process:
Equipment/room no.:
Previous Time:
product:
Batch no.: Date:

Date: Requested by:

Cleared by: Checked by: Checked by:

Process:
Equipment/room no.:
Previous Time:
product:
Batch no.: Date:

Date: Requested by:

Cleared by: Checked by: Checked by:

Process:
Equipment/room no.:
Previous Time:
product:
Batch no.: Date:

Date: Requested by:

Cleared by: Checked by: Checked by:

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Attachment (E) SOP No.:

AREA/EQUIPMENT/LINE Issued on: mm/dd/yyyy
CLEARANCE Revision No.: New
PACKAGING
___Previously finished stock/component removed along with the previous product
documents
___Equipment, area, belt cleaned
___Correct product and commodities available for which line clearance required
___All other requirements followed as mentioned in related SOPs

Previous Product on the Previous Product on the Line

Line Product:
Product: Code no.:
Code no.: Batch no.:
Batch no.: Consignee:
Consignee: Date: ___________________
Date:
___________________

Product for Which Line Clearance Required

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Product:
Code no.:
Batch no.:
Line no.:
Consignee: Number Consignee:
Time: of Time:
units
Date: rejected Date:
during
setup
Cleared by: (line Number Cleared by: (line boss)
boss) of units
Checked by: for Checked by: (supervisor)
(supervisor) rework
Verified by: Verified by: (QAI)
(QAI)
Consignee: Number Consignee:
Time: of Time:
units
rejected
Date: during Date:
setup
Cleared by: (line Number Cleared by: (line boss)
boss) of units
Checked by: for Checked by: (supervisor)
(supervisor) rework
Verified by: Verified by: (QAI)
(QAI)
Consignee: Number Consignee:
Time: of Time:
units
Date: rejected Date:
during
setup
Cleared by: (line Number Cleared by: (line boss)
boss) of units
Checked by: for Checked by: (supervisor)
(supervisor) rework
Verified by: Verified by: (QAI)
(QAI)
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Attachment (F) SOP No.:

QA IN-PROCESS X- AND R-CHARTS Issued on: mm/dd/yyyy
Revision No.: New
Date/T ime Individual FillVolume Individual Fill Weight (g) Average Range
1
Product:
2 Machine: Target:
3 Process: UCL: LCL: (In-process limit)
4
Code no.: Operator: UCL: LCL: (Lab. limit)
Batch size:
5
6
Batch
7 no.: Room no.:
8
9
X-Chart
1
0 Limi
ts 1 2 3 4 5 6 7 8 9 10
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

R-Chart
S. No. Length Sealing Free fr om P articles Breaking Ring Limi
1 ts 1 2 3 4 5 6 7 8 9 10
2
3
4
5
6
7
8
Inspection
9 of Filled and Sealed Vials/Ampoules/
10

Description of Any Corrective Action

Ceramic printing

Batch ________________________________________
Average:_________________ Signature (Quality Assurance Inspector)

Attachment (G)
Issued date: mm/dd/yyyy
Revision no.:
Date: _________________
From: Production Supervisor
To: Quality Assurance Inspector
Subject: Leak Test/Visual Inspection
Product: __________________________
Code: _____________
Batch no.: _____________
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Conclusion
Result
Signature (Passes/Fail (OK/Repeat Signature
Sample Status Supervisor s) ) (QAI) Date
After leak test
Leak test
Repeat 1
Leak test
Repeat 2
After optical
Inspection
Optical inspection
Repeat 1
Optical inspection
Repeat 2

In Case of Dispute
Remarks by system and inspection officers:

Remarks by operation and QA managers:

Signature/Date:

Attachment (H) Issued Date: mm/dd/yyyy

OPTICAL INSPECTION REPORT Revision No.: New
IN-PROCESS CONTROL
Product name:

Batch no.:

Code no.:

Sample size:

First Second
Optical Inspection for Sample Sample Remarks
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Clarity of solution
Particles
Color (as specified)
Fibers
Glass pieces/glass dust
Ampoule defect (sealing )
Charring (burning of solution near the
tip)
Break ring color/color code
Presence of OPC (one point cut)
Printing (if applicable)
Others

Disposition: conforms/does not conform

Optical inspection by: _________________________ Date: _________________

Attachment (J)
MILITARY STANDARD 105-E
GENERAL INSPECTION LEVEL-I

Double Sampling Plan

Cumul.
Code Critical Major Minor
Lot Size Sample Sample Defects Defects Defects
or Lette AQL AQL AQL
Batch Size r Size Size 0.0% 1.0% 2.5%
Acc Rej Acc Rej Acc Rej
. . . . . .
2– A 2 — 0 1 0 1 0 1
8
Single Sampling Plan
9– A 2 — 0 1 0 1 0 1
15
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Single Sampling Plan

16 B 3 — 0 1 0 1 0 1
–25
Single Sampling Plan
26 C 5 — 0 1 0 1 0 1
–50
Single Sampling Plan
51 C 5 — 0 1 0 1 0 1
–90
Single Sampling Plan
91 D 8 — 0 1 0 1 0 1
–150
Single Sampling Plan
15 E 13 — 0 1 0 1 1 2
1–280
Single Sampling Plan
28 F 20 — 0 1 0 1 1 2
1–500
Single Sampling Plan
Notes: Acc. = acceptance number; Rej. = rejection number; Cumul. =
cumulative sample.
If acceptance number exceeded on the first sample, but rej. number
is not crossed, inspect another sample.
If rejection number exceeded on the first sample, no second sample
is taken.
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL /015/F/01
QA Responsibilities in Injectable Area inspection Form

Attachment (K) SOP No.:

MILITARY STANDARD 105-E Issued on: mm/dd/yyyy
GENERAL INSPECTION LEVEL-I Revision No.: New

Double Sampling Plan

Critical Major Minor
Defects Defects Defects
Cumul.
AQL 0.0% AQL 1.0% AQL 2.5%
Lot Size or Code Sample Sample
Batch Size Letter Size Size Acc. Rej. Acc. Rej. Acc. Rej.
501–1200 G 20 20 0 1 0 2 0 3
20 40 0 1 1 2 3 4
1201–3200 H 32 32 0 1 0 2 1 4
32 64 0 1 1 2 4 5
3201–10,000 J 50 50 0 1 0 3 2 5
50 100 0 1 3 4 6 7
10,001–35,000 K 80 80 0 1 1 4 3 7
80 160 0 1 4 5 8 9
35,001–150,000 L 125 125 0 1 2 5 5 9

125 250 0 1 6 7 12 13
150,001–500,000 M 200 200 0 1 3 7 7 11

200 400 0 1 8 9 18 19
500,001+ N 315 315 0 1 5 9 11 16
315 630 0 1 12 13 26 27