Danish Med Agency GMP Certificate DK H 00029513 - Sterigenics
Danish Med Agency GMP Certificate DK H 00029513 - Sterigenics
Danish Med Agency GMP Certificate DK H 00029513 - Sterigenics
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Sundhedsstyrelsen<br />
<strong>Danish</strong> Hea[th and <strong>Med</strong>icines Authority<br />
CetWcate No. <strong>DK</strong> H <strong>00029513</strong><br />
Part 1<br />
CERTIFICATE OF <strong>GMP</strong> COMPLIANCE OF A MANUFACTURER<br />
Issued following an inspection in accordance with Art. 111(5) of Directive 20011831EC as amended.<br />
The competent authority of Denmark confirms the following:<br />
The manufacturer <strong>Sterigenics</strong> Denmark A/S<br />
Site address Aa. Louis-Hansens Allé 11<br />
3060<br />
Espergrde<br />
Denmark<br />
has been inspected under the national inspection programme in connection with manufacturing<br />
authorisation no. 16301 in accordance with Art. 40 of Directive 2001/83/EC transposed in the following<br />
national legislation: (Consolidated) <strong>Med</strong>icinal Products Act, 2005, as amended.<br />
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on<br />
2012/1 2/1 3, it is considered that it complies with the Good Manufacturing Practice requirements referred to in<br />
the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC2.<br />
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and<br />
should not be relied upon to reflect the compliance status if more than three years have elapsed since the<br />
date of that inspection, after which time the issuing authority should be consulted.<br />
The authenticity of this certificate may be verified with the issuing authority.<br />
Axel Heides Gade 1 Tel. ÷45 72 22 74 00<br />
<strong>DK</strong>-2300 København S www.sst.dk<br />
Page: 1 of 2 EMENINSI<strong>GMP</strong>/313556/2006/MRA<br />
The certificate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
- Authonsed<br />
- Authorised<br />
.dhedsstyreIsen<br />
<strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
Certcate No <strong>DK</strong> H rOO29Ei3<br />
Part 2<br />
Human <strong>Med</strong>icinal Products<br />
1 MANUFACTURING OPERATIONS<br />
- Authorised<br />
manufacturing operations include total and partial manufacturing (including various processes of dividing<br />
up, packaging or presentation), batch release and certification, storage and distribution of specified dosage forms<br />
unless informed to the contrary.<br />
- Quality control testing and/or release and batch certification activities without manufacturing operations are specified<br />
under the relevant items.<br />
- If the company is engaged in manufacture of products with special requirements e.g. radiopharmaceuticals or products<br />
containing penicillin, cytotoxics, cephalosporins, substances with hormonal activity or other potentially hazardous ac<br />
tive ingredients this is stated under the relevant product type and dosage form.<br />
F<br />
1.4 Other products or manufacturing activity %_- 4’<br />
1.4.2 Sterilisation of active substances/excipients/finished product: Sterilisati n e sub-<br />
1.4.2.6 Electron beam Electron beam<br />
÷ Irradiation of medicinal components<br />
1.6 Quality control testing<br />
1.6.1 Microbiolo ical: sterility Microbiolo ical: sterility<br />
1.6.2 Microbiological: non-sterility Microbiological o<br />
2 IMPORTATION OF MEDICINAL PRODUCTS<br />
Li<br />
importation activities without manufacturing activity<br />
importation activities include storage and distribution unless informed to the contrary<br />
Quality control testing of imported medicinal products<br />
2.1.1 Microbiological: sterility Microbiological: sterility<br />
2.1.2 Microbiological: non-sterility Microbiological: non-sterility<br />
Manufacture of active substance. Names of substances subject to inspection:<br />
None<br />
Any restrictions or clarifying remarks related to the scope of this certificate:<br />
Not applicable<br />
Date: 2013/03/11<br />
Name and signature of the authorised person<br />
of the competent authority of Denmark:<br />
Claus Mortensen<br />
The <strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
Axel Heides Gade 1<br />
<strong>DK</strong>-2300 København S<br />
Tel. +45 72 22 74 00<br />
www.sst.dk<br />
Page: 2 of 2<br />
EMEA/INS/<strong>GMP</strong>/313556/2006 I MRA<br />
The certificate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
S1ndhedsstyreLsen<br />
<strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
Certflcate No. <strong>DK</strong> V OOO295 3<br />
CERTIFICATE OF <strong>GMP</strong> COMPLIANCE OF A MANUFACTURER<br />
Part 1<br />
Issued following an inspection in accordance with Art. 80(5) of Directive 20011821EC as amended.<br />
The competent authority of Denmark confirms the following:<br />
The manufacturer <strong>Sterigenics</strong> Denmark A/S<br />
Site address Aa. Louis-Hansens AIlé 11<br />
3060<br />
Espergrde<br />
Denmark<br />
has been inspected under the national inspection programme in connection with manufacturing<br />
authorisation no. 16301 in accordance with Art. 44 of Directive 2001/82/EC transposed in the following<br />
national legislation: (Consolidated) <strong>Med</strong>icinal Products Act, 2005, as amended.<br />
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on<br />
201 2/1 2/1 3, it is considered that it complies with the Good Manufacturing Practice requirements referred to in<br />
the principles and guidelines of Good Manufacturing Practice laid down in Directive 91/412/EEC2.<br />
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and<br />
should not be relied upon to reflect the compliance status if more than three years have elapsed since the<br />
date of that inspection, after which time the issuing authority should be consulted.<br />
The authenticity of this certificate may be verified with the issuing authority.<br />
b<br />
Axel Heides Gade 1<br />
<strong>DK</strong>-2300 København S<br />
Tel. +45 72 22 74 00<br />
www.sst.dk<br />
Page: 1 of 2 EMENINS/<strong>GMP</strong>/313556/2006 I MRA<br />
The certificate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
- Authorised<br />
- If<br />
- Authorised<br />
SIrdhedsstyre[sen<br />
<strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
Cei5cate No <strong>DK</strong> V <strong>00029513</strong><br />
Part 2<br />
Veterinary <strong>Med</strong>icinal Products<br />
1 MANUFACTURING OPERATIONS<br />
- Quality<br />
manufacturing operations include total and partial manufacturing (including various processes of dividing<br />
up, packaging or presentation), batch release and certification, storage and distribution of specified dosage forms<br />
unless informed to the contrary.<br />
control testing and/or release and batch certification activities without manufacturing operations are specified<br />
under the relevant items.<br />
the company is engaged in manufacture of products with special requirements e.g. radiopharmaceuticals or products<br />
containing penicillin, cytotoxics, cephalosporins, substances with hormonal activity or other potentially hazardous ac<br />
tive ingredients this is stated under the relevant product type and dosage form.<br />
1.4 Other products or manufacturing activity<br />
1.4.2 Sterilisation of active substances/excipients/finished product: Sterilt n sub<br />
stances/excipients/finished product:<br />
1.4.2.6 Electron beam Electron beam<br />
+ Irradiation of medicinal components<br />
1.6 Quality control testin<br />
1.6.1 Microbiological: sterility Microbiological: sterili<br />
1.6.2 Microbiological: non-sterility Microbiolo ica o<br />
2 IMPORTATION OF MEDICINAL PRODUCTS<br />
- Authorised<br />
importation activities without manufacturing activity<br />
importation activities include storage and distribution unless informed to the contrary<br />
2.1 Quality control testing of imported medicinal products<br />
2.1.1 Microbiological: sterility Microbiological: sterility<br />
2.1.2 Microbiological: non-sterility Microbiological: non-sterility<br />
Manufacture of active substance. Names of substances subject to inspection:<br />
None<br />
Any restrictions or clarifying remarks related to the scope of this certificate:<br />
Not applicable<br />
Date: 201 3/03/11<br />
Name and signature of the authorised person<br />
of comjauthoritY of Denmark:<br />
Claus Mo<br />
ensen<br />
The <strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
Axel Heides Gade 1 Tel. +45 72 22 74 00<br />
<strong>DK</strong>-2300 København S www.sst.dk<br />
Page: 2 of 2<br />
EMEN1NSI<strong>GMP</strong>/313556/2006/MRA<br />
The cerhficate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
Sundhedsstyretsen<br />
<strong>Danish</strong> Health and <strong>Med</strong>icines Authority Oefcate No <strong>DK</strong> IMP OC295i3<br />
Part 1<br />
CERTIFICATE OF <strong>GMP</strong> COMPLIANCE OF A MANUFACTURER<br />
Issued following an inspection in accordance with Art. 15 of Directive 20011201EC.<br />
The competent authority of Denmark confirms the following:<br />
The manufacturer <strong>Sterigenics</strong> Denmark A/S<br />
Site address Aa. Louis-Hansens Allé 11<br />
3060<br />
Espergrde<br />
Denmark<br />
has been inspected under the national inspection programme in connection with manufacturing<br />
authorisation no. 16301 in accordance with Art. 13 of Directive 2001/20/EC transposed in the following<br />
national legislation: (Consolidated) <strong>Med</strong>icinal Products Act, 2005, as amended.<br />
From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on<br />
201 2/1 2/1 3, it is considered that it complies with the Good Manufacturing Practice requirements referred to in<br />
the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC2.<br />
This certificate reflects the status of the manufacturing site at the time of the inspection noted above and<br />
should not be relied upon to reflect the compliance status if more than three years have elapsed since the<br />
date of that inspection, after which time the issuing authority should be consulted.<br />
The authenticity of this certificate may be verified with the issuing authority.<br />
Axel Heides Gade 1 Tel. +45 72 22 74 00<br />
<strong>DK</strong>-2300 København S www.sst.dk<br />
Page: 1 of 2 EMEMNS/<strong>GMP</strong>/31355612006/MRA<br />
The certificate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
I<br />
- Authorised<br />
- Authorised<br />
:1rdhedsstyreLsen<br />
<strong>Danish</strong> Health and <strong>Med</strong>icines Authority Cetfict No. <strong>DK</strong> MP COC29513<br />
Part 2<br />
Human Investigational <strong>Med</strong>icinal Products<br />
1 MANUFACTURING OPERATIONS<br />
Authorised manufacturing operations include total and partial manufacturing (including various processes of dividing<br />
up, packaging or presentation), batch release and certification, storage and distribution of specified dosage forms<br />
unless informed to the contrary.<br />
Quality control testing and/or release and batch certification activities without manufacturing operations are specified<br />
under the relevant items.<br />
If the company is engaged in manufacture of products with special requirements e.g. radiopharmaceuticals or products<br />
containing penicillin, cytotoxics, cephalosporins, substances with hormonal activity or other potentially hazardous ac<br />
tive ingredients this is stated under the relevant product type and dosage form.<br />
1.4 Other investigational medicinal products or manufacturing activity<br />
1.4.2 Sterilisation of active substances/excipients/finished product: Sterilisation ofacre sub<br />
stances/excipients/finished product:<br />
Electron beam Electron beam<br />
+ diation of medicinal components<br />
1.6 Quality control<br />
1.6.1 Microbiological: sterility Microbiolo ical: sterili<br />
1.6.2 Microbiological: non-sterility Microbiologicaio<br />
2 IMPORTATION OF MEDICINAL PRODUCTS<br />
importation activities without manufacturing activity<br />
%<br />
importation activities include storage and distribution unless informed to the contrary<br />
2.1 Quality control testing of imported investigational medicinal products<br />
2.1.1 Microbiological: sterility Microbiological: sterility<br />
2.1.2 Microbiological: non-sterility Microbiological. non-sterility<br />
Manufacture of active substance. Names of substances subject to inspection:<br />
None<br />
Any restrictions or clarifying remarks related to the scope of this certificate:<br />
The certificate also applies to investigational veterinary medicinal products<br />
Date: 2013/03/11<br />
Name and signature of the authorised person<br />
of t competent authority of Denmark:<br />
/t<br />
Claus Mortensen<br />
The <strong>Danish</strong> Health and <strong>Med</strong>icines Authority<br />
f<br />
P<br />
Axel Heides Gade 1<br />
<strong>DK</strong>-2300 Kobenhavn S<br />
Tel. +45 72 2274 00<br />
www.sst.dk<br />
Page: 2 of 2<br />
EMENINS/<strong>GMP</strong>/31 3556/2006 / MRA<br />
The certificate may not be reproduced, except in its complete form, without a written consent of the <strong>Danish</strong> Health and <strong>Med</strong>icines Authority
Change language