Turntable Operation Basel
Lichtstrasse 35
4056 Basel Switzerland
Logistic Cover Sheet N° CH010400337955
to Batch Certificate
Product Name:
CATAF FCT 12.5MG ACP (X10) R07C
Customer's Product
Name:
Global Valuated
Material N°:
727376
Batch N°:
Batch Certificate N°:
B6317
ES100200066403
Global Non Valuated
Material N°:
Customer N°:
Customer Name:
CH6314
NOVARTIS CONSUMER HEALTH SA , NYON , Switzerland
Ship to N°:
Ship to Party:
CH6314
Country Code:
CH
NOVARTIS CONSUMER HEALTH SA , NYON , Switzerland
Pharma Outbound
Delivery No:
5001071168. 10
Purchase Order N°
of End Customer:
4500327400
Sales Order No
vs. End Customer: 1000887963
Shipped
Quantity:
15,850.000
Unit: PC
Additional Logistic Information:
Logistic Manager:
Page 1 / 8
Page 1 / 1
Piero IANNI
Date:
10-JUL-2013
Issued by:
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210 Barberà del Vallès
Manufacturing License No:
1520-E
GMP Certificate No:
NFC/1227/001/CAT
Batch Certificate
No ES100200066403
Product Name:
Strength/Potency:
Dosage Form:
Package type:
Package size:
Country of Destination:
Global Material No:
Date of Manufacturing:
Release Date:
Expiry Date:
Production Qty:
VOLTAREN DOLO ACP 10 FCT-R07
DICLOFENAC POTASSIUM 12.5 MG
Film-coated Tablet
Blister
1X10 Piece
Switzerland
727376
Batch N°:
02-MAY-2013
02-JUL-2013
APR-2016
15850.000 PC
B6317
For Tests, Requirements, Results and Conclusions refer to the following Certificate(s):
Certificate No
Product Name:
Global Material N°:
Local Material N°:
Release Date:
Manufacturing Site:
Manufacturing License:
Certificate No
Product Name:
Global Material N°:
Local Material N°:
Release Date:
Manufacturing Site:
Manufacturing License:
Page 2 / 8
Page1 / 2
ES100100047205
VOLTAREN DOLO ACP 10 FCT-R07
727376
Batch N°:
727376
02-JUL-2013
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210 Barberà del Vallès
1520-E
ES100100045107
DICLOFENAC-K/SPF 12.5 MG COMP LAC-EC
854270
Batch N°:
854270
31-MAY-2013
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210 Barberà del Vallès ES
1520-E
B6317
B6317
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
Issued by:
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210 Barberà del Vallès
Manufacturing License No:
1520-E
GMP Certificate No:
NFC/1227/001/CAT
Batch Certificate
No ES100200066403
Product Name:
Global Material No:
VOLTAREN DOLO ACP 10 FCT-R07
727376
Batch N°:
B6317
Certification Statement:
I hereby certify that the above information is authentic and accurate. This batch of product has been fabricated / manuf
actured, including packaging and quality control at the above mentioned site(s) in full compliance with GMP requirements
of the local Regulatory Authority and with the specifications in the Marketing Authorisation of the importing country.
The batch processing, packaging and analysis records were reviewed and found to be in compliance with GMP.
Authorized Person:
Date and Time:
Fco Javier GONZALEZ PASCUAL
02-JUL-2013 09:37:14
Issuer of Certificate:
Date and Time:
Fco Javier GONZALEZ PASCUAL
02-JUL-2013 09:37:14
Page 3 / 8
Page2 / 2
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
Certificate of Analysis
No ES100100047205
Product Name:
VOLTAREN DOLO ACP 10 FCT-R07
Global Material N°:
727376
Issued by :
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210Barberà del Vallès
Spain
Batch No :
B6317
Date of Manufacturing 02-MAY-2013
Expiry Date
30-APR-2016
Testing Monograph:
Tests
DP_3759669_B_R_2
Analysis No: 4130033863
Requirements
Results
Primary packaging
According to reference
Complies
Secondary packaging
According to reference
Complies
Leaflet
According to reference
Complies
Batch number
According to the primary/final
packaging
Complies
Expiry date
35 months
Complies
Conclusion
The batch complies with the testing monograph. It is hereby certified that the above information is authentic and
accurate and that the analysis records have been reviewed and found to be in compliance with GMP.
Authorized Person
Date and Time:
Fco Javier GONZALEZ PASCUAL
01-JUL-2013
17:27:14
Issuer of Certificate
Date and Time:
Fco Javier GONZALEZ PASCUAL
02-JUL-2013
09:37:19
Page1 /
Page 4 / 8
1
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
Certificate of Analysis
No ES100100045107
Product Name:
DICLOFENAC-K/SPF 12.5 MG COMP LAC-EC
Global Material N°:
854270
Issued by :
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210Barberà del Vallès
Spain
Batch No :
B6317
Date of Manufacturing 02-MAY-2013
Expiry Date:
02-MAY-2014
Testing Monograph:
Tests
DP_3759669_B_R_2
Analysis No: 4130032906
Requirements
Results
Appearance: Shape
Oblong, smooth, film-coated
tablets
Complies
Appearance: Colour
White
Complies
Length
10.8 - 11.6 mm
11.1 mm
Thickness
3.7 - 4.2 mm
3.8 mm
Width
5.4 - 5.9 mm
5.5 mm
Mean weight
198 - 214 mg
203 mg
Page1 /
Page 5 / 8
4
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
Certificate of Analysis
No ES100100045107
Product Name:
DICLOFENAC-K/SPF 12.5 MG COMP LAC-EC
Global Material N°:
854270
Issued by :
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210Barberà del Vallès
Spain
Batch No :
Tests
Requirements
Results
Identity of potassium
Positive
Complies
Identity by UV: Diclofenac Potassium
Corresponds to the reference
Complies
Identity by HPLC: Diclofenac Potassium
Corresponds to the reference
Complies
GP 45828, based on the declared content of
Diclofenac Potassium
Max 0.3 %
< 0.1 %
GP 49002,based on the declared content of
Diclofenac Potassium
Max 0.5 %
< 0.1 %
GP 49000,based on the declared content of
Diclofenac Potassium
Max 0.3 %
< 0.1 %
Unspecified degradation products individually based Max 0.2 %
on the declared content of Diclofenac Potassium
< 0.1 %
Page2 /
Page 6 / 8
4
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
B6317
Certificate of Analysis
No ES100100045107
Product Name:
DICLOFENAC-K/SPF 12.5 MG COMP LAC-EC
Global Material N°:
854270
Issued by :
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210Barberà del Vallès
Spain
Batch No :
Tests
Requirements
Results
Total degradation products by HPLC
Max 1.2 %
< 0.1 %
Assay by HPLC: Diclofenac Potassium
95.0 - 105.0 %
98.9 %
Content Uniformity: n=10 or 30
10 - 30
10
Content Uniformity of Diclofenac Potassium:
Average
-
97.7 %
Content Uniformity: Min. value
-
96.6 %
Content Uniformity: Max. value
-
98.3 %
Content Uniformity: Acceptance value
Max 15.0
2.3
Content Uniformity: Final conclusion
Meets requirements of Ph.Eur.
Complies
Page3 /
Page 7 / 8
4
This certificate has been automatically generated.
The data have been approved by an Authorized Person.
B6317
Certificate of Analysis
No ES100100045107
Product Name:
DICLOFENAC-K/SPF 12.5 MG COMP LAC-EC
Global Material N°:
854270
Tests
Issued by :
Novartis Farmacéutica, S.A.
Pharmaceutical Operations
Ronda Sta. María 158
08210Barberà del Vallès
Spain
Batch No :
Requirements
Dissolution: n=6, 12 or 24
6 - 24
B6317
Results
6
Dissolution of Diclofenac Potassium (AVG) after 30 Min 80 %
min
102 %
Dissolution: Min. value
-
100 %
Dissolution: Max. value
-
103 %
Dissolution: Final conclusion
Meets requirements of Ph.Eur.
Complies
Conclusion
The batch complies with the testing monograph. It is hereby certified that the above information is authentic and
accurate and that the analysis records have been reviewed and found to be in compliance with GMP.
Authorized Person
Date and Time:
Jordi TOME GARCIA
30-MAY-2013
10:16:36
Issuer of Certificate
Date and Time:
Fco Javier GONZALEZ PASCUAL
31-MAY-2013
10:05:04
Page4 /
Page 8 / 8
4
This certificate has been automatically generated.
The data have been approved by an Authorized Person.