MIDDLE

t.

EAST

Standard Operating Procedure

CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No:

I Version

Document # : WH-005
Prepared

Compliance

by

Name: Mr. George

Ibrahim
Position: Sales Manager
Signature:G~orOe..
Date:

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2.5 (1(2.. i)f3

# : 01

Approval

I Effective
Management

Date:

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

Date:

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dated:
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Date:
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Approval

Name:Dr. So ad Mahmoud

Signature:

Page # lof7

Signature:

1. Purpose:
Protection of TTSPPs products during the labeling process.

2. Scope:
TTSPPs - Orencia (lyophilized powder for LV. infusion).

3. Responsibilities:
3-1 Cold room storekeeper
3-2 Responsible Pharmacist
3-3 Warehouse Manager
3-4 Relevant Sales Manager

4. Definitions:
Time- and Temperature-Sensitive
Pharmaceutical Product (TTSPP)
Any pharmaceutical good or product which, when not stored or transported
within predefined environmental conditions and/or within predefined time
limits, is degraded to the extent that it no longer performs as originally Intended.

5. Materials & equipment:

Silk screen stamp.

6. Flow chart (Flow Diagram):

N/A

t.

Standard Operating Procedure

MIDDLE EAST CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No :

I Version

Document # : WH-005

# : 01

Compliance Approval

Prepared by

I Effective

Page#

Management Approval
Name: Dr Atef Adib

Position: Sales Manager

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

Signature:

Signature:

Date:

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Date:

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Date:

Name:Dr. Soad Mahmoud

Name: Mr. George

Ibrahim

Signature:

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Revised Date:
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Issue date: 2.)"

7- Procedure:
First: General Requirements for labeling TTSPPproducts:
7-1 The labeling /stamping process must be carried out inside the cold room
(2 e-a' c)
0

7-2 The silk screen stamp is prepared and implemented by specialized subContractor and under the supervision of the responsible pharmacist.
7-3 The data to be printed must be reviewed and approved by the responsible
pharmacist before implementation.
7-4 If any deviation or excursion is happened during the labeling process:
A-Responsible pharmacist must follow Deviation SOP # QC-004
B-Sales manager must inform the manufacturer and! or marketing
authorization holder of the product under labeling about the
deviation! excursion.
7-5 Records for labeling process must be carried out at the time each operation
is under taken.

Second: In-process Control:

7-6 Ensure that the reading of the 2 data loggers (maximum &minimum
temperature) is within the acceptable range (2c _8 c) before starting the
labeling process and after completion of the process.
0

7-7 The correctness and the quality of the label must be checked during the
period of labeling process for each pack.

MIDDLE

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t.

Standard Operating Procedure

CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No:

I Version # : 01

Document # : WH-005

Name: Mr. George

Ibrahim
Position: Sales Manager

G.~DY"'~
1-5(1/~olS

Signature:
Date:

I Effective Date:

Compliance Approval

Prepared by

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Page # 30f7

Management Approval

Name:Dr. Soad Mahmoud

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

Signature:
Date:

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Issue date: ~Z

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Revised Date:

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Third: Data Interpretation:

7-8 Calculate & Record the reconciliation of the labeled product.

7-9 Investigate discrepancy (if any), determine the root cause of the loss and
take the necessary corrective action(s).

Fourth: Records
7-10 tabeling process is recorded in form #WH-OOS-Fl"Record for labeling
of
TTSPP"
7-11 Record for labeling of nspp must be kept for one year after the expiry
date of the batch of the product under labeling or for 5 years, which is longer.

8. References
Annex (9) - WHO Model guidance for the storage and transport of time- and
temperature- sensitive pharmaceutical products.

9. Forms / Attachment
Records for labeling ofTTSPP products (Form # WH-005-Fl)

Standard Operating Procedure

MIDDLE

EAST

CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No :

I Version

Document #: WH-005

Compliance Approval

Prepared by
Name: Mr. George
Ibrahim
Position: Sales Manager

8. ~o r \Q.. \
Z-S/'1- I 'Lol3

I Effective

Date:

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

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Date:

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Signature:~

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Issue date:

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dated:
- 11 Revised Date:
1- 1

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Record for labeling TTSPP product

1- Product:

Product Name:

Code: ................................................................................

Pharmaceutical form:

Strength:

Batch/lot number:

Manufacturing

Expiry date:

- - 1- -1- - - -

Manufacturerl

Marketing Authorization Holder: ..........................

Quantity to be labeled: ......................................................

date:

- - 1 - - 1- - - -

2- Information to be labeled:

Batch Number:

Manufacturing

Date: - - 1- - 1 - - - -

Expiry Date:

- - 1--I - - - -

Other Information:

Warehouse Manager
Name:
Signature & Date

Responsible pharmacist
Name:
Signature & Date

40f7

01 108 12013

Management Approval

Name:Dr. Soad Mahmoud

Signature:

Signature:
Date:

# : 01

Page#

MIDDLE

t.

EAST

Standard Operating Procedure

CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No:

I Version

Document # : WH-005

Compliance Approval

Prepared by
Name: Mr. George
Ibrahim

Date:

Date:

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

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Signature: rr () ~'

Date:.2

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Issue date:

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/2013

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dated:
/ - /-

Signature:

L5ft (2013

01 /08

Management Approval

Name:Dr. Soad Mahmoud

Position: Sales Manager

Signature:

I Effective

# : 01

Page # 50f7

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Revised Date:
_ /

_ /_

t:'5/:;ftpl3

3- Facility:

Warehouse
Name & Code:

Cold Room Code: ...........................

Accepted Temperature Range (
Certificate of calibration

To

) 'c

#..........................

Due Date

- - /- -/- - - -

Data Logger:
Certificate of calibration #
Due Date - - /- - /- - - Reading before starting the labeliog process (max ...........
Time:

Hr.

Min

-min ......... ) 'c

Reading after completion oflabeling process (max .......... -min

Time:

Hr.

Min. .

Cold room Storekeeper

Name:
Signature & Date

) "c

Responsible Pharmacist
Name:
Signature &Date

4-Labeling Process
Date:

- - / - -/ - - -

Time: Hr:

Min:

A- Before Start labeling process:

Examine the labeling area (inside the cold room) for clearance of any products
other than the required one.
Examine containers for Tampering, Damage or Contamination and record any
observation(s)
.

Standard Operating Procedure

MIDDLE

EAST

CHEMICALS

Document Name: Labeling of TTSPPs Products

Copy No:

I Version

Document # : WH-005
Prepared

Compliance

by

Name: Mr. George

Ibrahim
Position: Sales Manager
Signature: ~~() ('
Date:

Q.

7....S/7 12 a( J

I Effective

# : 01

Approval

Management

Page#

Date:

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

8\=\~~

Signature:
Date:

01 108 12013

Approval

Name:Dr. So ad Mahmoud

Issue date:~~;

Replace SOP
dated:
I - 1Revised Date:
- I - 1-

Signature:

.2..5/=t-/~\

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B-During Process:

Check accuracy of printed data (for each pack)

Check Quality of printing (for each pack)
Record any non- compliance

C- After end of labeling Process

End Time: Hr
Total Time of Process:

Min. .

.
Min. .

Hr

Company Representative

Sub-contractor Representative
Name:

Name:

Signature & Date

Signature & Date

5-Reconcillation:
Calculate Reconciliation & Investigate any Loss.
Total Quantity to be labeled (A):
Printed Quantity (B):
Difference (if any):

pack
pack

A- B

% Loss =( C lA) X 100 =

= (C) .....................

Pack

Responsible pharmacist
Name:
Signature & Date
WH-005-FI

MIDDLE

EAST

t.

Standard Operating Procedure

CHEMICALS

Copy No:

I Version

Document # : WH-005

Compliance

Prepared by
Name: Mr. George
Ibrahim
Position: Sales Manager
Signature: ~o
Date:

of TTSPPs Products

Document Name: Labeling

?-5/11

r~ e.

z-{3

# : 01

Approval

I Effective

Page # 7of7

Date:

Management Approval

Name:Dr. Soad Mahmoud

Name: Dr Atef Adib

Position: Quality
&Compliance Consultant

Position: General
Manager (MEC)

Signature:
Date:

Se~

M~"""'"

25J41 ~\3

01 /08

Signature: ~
Issue date:

Replace SOP
dated:
//

zr /t /lal

Version

01/08/2013

01

Change Summary

t" issue

Revised Date:
/ - /-

10. History

Effective Date

/2013