certificate of good manufacturing practices

Transcription

GOVERNMENT OF INDIA
Directorate General of Health Services
Ministry of Health & Family Welfare
Central Drugs Standard Control Organization
Certificate of Good Manufacturing Practices
(This one -page certificate conforms to the format recommended by the World Health Organization
(general instructions and Explanatory notes attached). I
Certificate
No: -
eM pI H ~) SITe rOD)-/
?-,.Du':
sri, -\ ,
I,
On the basis of the inspection carried out on '211b~ ,>' to ')'2- It:>
we certify that the site indicated on this
certificate complies with Good manufacturing Practices for the dosage forms, categories and activities listed in
Table 1.
1. Name and Address
of Site:
Mis. Charak Pharma Pvt.Ltd.
Plot No. 371, Sayli-Rakholi Road, Silvassa-396 230
U.T.Of Dadra and Nagar Haveli (India)
2. Manufacturer's
Licence Number:
DNH/AYU/20
3. Table:
1
Dosage Form (S)
Liquid Orals
Capsules
Category
(ies)
Activity (ies)
Menstrual Modulator,
Antioxidant & Immunity booster, Digestive aid,
Relieves Cough ,hepatoprotector,Appetite Stimulant,
Anti -nauseant,anti-emetic,Bronchodiiator
,
Anti - Inflammatory ,Anti -a1Jergic,Carminati ve
,Carminative, Cognitive insufficiency,
Anti-histaminic, to treat Menorrhagia,
Immunity Enhancer, Urine alkaliser
Spermatogenetic,Anti-oxidant & Immunity booster,
To treat Post Menopausal Syndrome,
hepatoprotector.Apbrodisiec, Menstrual Regulator,
Anti- Inflammatory, Myocardial tonic.Anti-Pyretic
diaphoretic,haemostyptic,comedolytic and
Anti-microbial, Anti- allergic and Anti-Pruritic.
Production ,Quality
Control,Labelling &
Packing
Production ,Quality
Control,Labelling &
Packing
The responsibility for the quality of the individual batches of the Pharmaceutical products manufactured through
this process lies with the manufacturer,
This certificate remains valid until 0&. D2. ?-o I 7 .It becomes invalid if the activities and/or categories
certified herewith are changed or if the site is no longer considered to be in compliance with GMP.
.Address of Certifying authority:
Central Drugs Standard Control Orga ization,
FDA Bhavan,ITO ,Kotla Road,
New Delhi- 110 002
Dr. G. N. SINGH
Drugs Controller General (India)
Dte.Generalof ,ulth s '''·''I(e.s
Ministry of He" .th n Family \~j6Itars
FDA Bhawan, Ko\la Ruad, I.T.O.
New Delhi-l10uU2
Name and Function of responsible
Dr. G.N. Singh
Drug Controller General (I),
Email: [email protected]
Telephone No:- 91 11 23236965
Fax N~
91 1] 23236973
(IU'{}.OG ~If\P.<$fN, -1
.~i~If(jff'er
e~j\,liI\)TIWit)
sJe~<9~l'!Ofl}i~-!H1
-, .;
~~Iif@.
(~1lmM9,
tft;,lTi-ClI
.
'~I
-I~JJga'~..;(1 I 1 0
H~Mtl:leJi'tjl:Ou'J': '
,
,
person:
(This model certificate for GMP is not part of the WHO certification scheme on the Quality of Pharmaceutical Products
Moving in International Commerce..)
Explanatory Nates
(l)This certificate, which is in the format recommended by WHO, certifies the status of the Site listed in Point
1 of the certificate.
(2)The certification number should be traceable with in the regulatory authority issuing the certificate.
(3) Where the regulatory authority issues a licence for the site this number should be specified. Record "Not
Applicable" in case where there is no legal framework for the issuing
a licence.
(4) Table 1
or
List of dosage forms, starting materials, categories and activities.
Example
1
_Pharmaceutical
Product (s) 2
Category (ies)
Activity (ies)
Dosage Form (s):
Cytotoxic
Production
Hormone
Production ,Quality Control
& Packing
Penicillin
Repacking and Labell ing
Cefalosporin
Aseptic Preparation,
Packing, Labelling
Tablets
Injectables
Example 2
Pharmaceutical
Product (s) 2
Category (ies)
Activity (ies)
Starting Material (s) : 3
Synthesis ,Purification,
Packing, Labelling
2.Pharmaceutlcal Products :~Any medicine intended for human use or veterinary product administered to foodProducing animals, presented in its finished dosage for or as a starting material for use in such a dosage form, that is.subject
to control by pharmaceutical legislation in both the exporting state and the importing state.
Paracetamol
Analgesic
3. Starting Materials: Any substance of a defined quality used in the production of pharmaceutical product, but
excluding packaging materials.
lJse, whenever available,
Names.
International
nonproprietary
Names (INNs) or otherwise national nonproprietary
(5) The certificate remains valid until the specified date. The certificate becomes invalid if the activities and
categories certified are changed or if the site is no longer considered to be in compliance with GMP.
lor
(6) The requirements for good practices in the manufacture and quality control of drugs referred to in the
certificate are those included in Quality Assurance of pharmaceuticals: a compendium of guidelines anti related
materials. good manufacturing Practices and inspection, Volume 2, 1999. World health Organization, Geneva
and subsequent updates.
ANNEXURE
I
08/02/2017
WHO GMP Certificate No.
Charak Pharma Pvt. Ltd.
At: Plot No. 371, Sayli-Rakholi
SILVASSA - 396230.INDIA
Sr. No.
1.
2.
3,
4.
5.
6,
Name of country
Frel)ch Guiana
Gabon
Ghana
Guatemala
Georgia
Germany
Guyana
Greece
Guinea
Sr. No.
79.
80.
81.
82.
83.
84.
85,
86.
87.
Name of country
Malwai
Mauritius
Maldovia
Morocco
Mexico
Malavsia
Myan~;ar
Maur'tania
Madaaaskar
Sr. No.
118.
119.
120.
121.
122.
123.
124.
125.
126.
Name of country
South Africa'
Sudan
Singapore
Saudi Arabia
Seychelles
Seiraleone
Slovenia
Solomon Islands
Somali
8.
9.
10.
Burkina Faso
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
Mali
Malia
Mozambiaue
Monaco
Moncclla
Nepal
Nigeria
Nicaragua
Norway
Netherlands
Namibia
127.
128.
129.
130.
131.
132.
133.
134.
135.
136.
137.
138.
Somalia
Belgium
Brazil
Bahamas
Bangladesh
Barbados
Bolivia
Bulgaria
Botswana
Cameroon
Czech Republic
Cambodia
Hungary
Hong Kong
Honduras
Haiti
Hawai
Iceland
Iran
Iraq
Ivory Coast
Indonesia
Ireland
Italy
Maldives
11.
12.
13.
14.
15.
16.
17,
18.
19.
20.
21.
22.
China
61.
Jordan
100.
Newze.ands
139.
Thailand
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
Columbia
Costa rica
CIS
Congo
Chile
Canada
Cuba
Cyprus
Dominican Republic
Denmark
Egypt
Estonia
Ethiopia
EI-Salvador
Finland
Fiji
France
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
Jamaica
Japan
Kazakhstan
Kenya
Khvrohsztan
Kuwait
Korea
Leichestein
Lebanon
Latvia
Lithuania
Lesotho
Liberia
Libya
Luxembourg
Laos
Muscat
101.
102.
103,.
104.
105.
106.
107.
108.
109.
110.
111.
112.
113.
114.
115.
116.
117.
Niger
Oman
140.
141.
142.
143,
144.
145.
146.
147.
148.
149.
150.
151.
152.
153.
154.
155.
156.
157.
Tunisea
Taiwan
Turutky
U.A.E.
Uganda
United Kingdom
Ukraine
Uzbekistan
U.S.A.
. 'i.
-
Sr. No.
40.
41.
42.
43.
44.
45.
46.
47.
48.
Name of country
AJgeria
Australia
Armenia
Austria
Argentina
Azerbahan
Bahrain
Belarus
Benin
(J
,C_
Under License No: DNH/AYU/20 dated: 08101/2002
Road
72.
73.
74.
75,
76.
77.
78.
Phllipones
Panama
Peru
Pakistan
Papua-: :ew Guinea
Para1L:Cl'l
Portugal
Poland
Puer.o ~ic')
Qatar
Romania
Russia
Rwanda
Srilal,;o
SencQnl
South Korea
Spain
Surinam
Swaziland
Sweden
Syria
Slovak Republic
Switzerland
Tanzania
Togo
Thailand
Uruouav
Venezuela
Vietnam
Virgin Island
Yemen
Yuqoslavia
Zaire
Zambia
Zimbabwe
I
Address of certifying authority:
,j
NDARD CONTROL
CENTRAL DRUGS S
ORGANIZATION,
FDA BHAVAN, ITO,
~AD
NEW DELHI- 110 002
K,
Telephone No.:011-23236965
:011-23236973
Tele 1 Fax
o
Dr.G. N. SINGH
rugs Controll General(India)
M.Ote,General 0 He~l(hServices
Inlstry of He::.' h f- -"
FDA Bh
Fvmlly VVelfars
awan, Katia Read. LTO.
New Delhl-110002
Name of the authorized person:
Signature
Stamp
& Date
,
"
GOVERNMENT OF INDIA
(general instructions and Explanatory notes attached).'
Certificate No: -
c; M pI n1/ ~ II t3/
r-
0 3/ J.-o I
On the basis of the inspection carried out on 09/07/2015, we certify that the site indicated on this certificate
complies with Good manufacturing Practices for the dosage forms, categories and activities listed in Table 1.
1.Name and Address of Site:
Mis. Charak Pharma Pvt. Ltd.
Jaurasi Road, Pauti ViUage,G.T.Road ,
Samalkha .Distt. Panipat (Haryana).
2. Manufacturer's Licence Number:
114 - Ayur - (H)
3. Table: 1
Category (ies)
Activity (ies)
Anti - nauseant.anti-emetic.Bronchodilator
,
Anti- Inflammatory,Anti-aUergic,Carminative
Cognitive insufficiency, Anti-histaminic, to treat
Menorrhagia,Immunity
Enhancer, Urine
alkaliser.Anti-dibetic Anti-hypertensive & Mild
tranquilizer.Anti- flatulent & Mild laxative,
antilipidemic, anxiolytic &Energizer
Production ,Quality
Control.Labelling &
Packing
Dosage Form (S)
Tablets
The responsibility for the quality of the individual batches of the Pharmaceutical products manufactured through
this process lies with the manufacturer.
Iq.
This certificate remains valid until
08. 2. 0 17
.It becomes invalid if the activities and/or categories
certified herewith are changed or if the site is no longer considered to be in compliance with GMP.
'
r
Address of Certifying authority:
Name and Fu
Central Drugs Standard Control Organization,
FDA Bhavan,lTO ,Kotla Road,
New Delhi- Ito 002
Dr.G.N. Singh.
Drug Controller G neral (I),
Email: dcai oic. n
Telephone No:- t 11 23236965
Fax No: ] 11 2323691.3
l,," C
•
I
n of responsible person:
..
(This model certificate for GMP is not. part of the WHO certification scheme on the Quality of Pharmaceutical
Moving in International Commerce.)
.
Products
Explanatory Notes
(l)This certificate, which is in the format recommended by WHO, certifies the status of the Site listed in Point
Applicable" in case where there is no legal framework for the issuing of a licence.
(4) Table 1
Example
I
Pharmaceutical
Product (s) 2
Category (ies)
Activity (ies)
Dosage Form (s):
Cytotoxic
Production
Hormone
Production .Quality Control
& Packing
Penicillin
Repacking and Labelling
Cefalosporin
Packing, Labelling
Tablets
Injectables
Example 2
Pharmaceutical
Product
(s) 2
Category (ies)
Activity (ies)
Packing, Labelling
..
..
2.Pharmaceutlca.!Products :- Any medicine Intended for human use or veterinary product administered to food Producing animals, presented in its finished dosage for or as a starting material for use in such a dosage form, that is subject
Paracetamol
Analgesic
excluding packaging materials.
Use, whenever available, International
Names.
nonproprietary
Names (INNs) or otherwise national nonproprietary
(5) The certificate remains valid until the specified date. The certificate becomes invalid if the activities and
lor
certificate are those included in Quality Assurance of pharmaceuticals: a compendium of guidelines and related
GOVERNMENT OF INDIA
(general instructions and Explanatory notes attached).'
Certificate No: -
y MP Irt 1::> 151 t e: 10' /,2.D
1..(
On the basis of the inspection carried out on 10/07/2015 we certify that the site indicated on this certificate complies
with Good manufacturing Practices for the dosage forms, categories and activities listed in Table 1.
1.Name and Address of Site:
Mis. Charak Pharrna Pvt.Ltd.
Village Katha, P.O. Baddi, The.
Nalagarh, Dist Solan, H. P. 173205
2. Manufacturer's
Licence Number:
HP-128-Ay
3. Table: 1
Dosage Form (S)
Category (ies)
Activity (ies)
Tablets
Anti -nauseant,anti-emetic,Bron.chodilator
,
Anti- Lnflammatory ,Anti-aliergic,Carm inative
,Carminative, Cognitive insufficiency,
Anti-histaminic, to treat Menorrhagia,
Immunity Enhancer, Urine alkaliser
Production ,Quality
Control,Labelling &
Packing
The responsibility for the quality of the individual batches of the Ph~:'maceutical products manufactured through
this process lies with the manufacturer.
2 B, 7
This certificate remains valid until
b t 2-0 1 .{.,
.Itbecomes invalid if the activities and/or categories
certified herewith are changed or if the site is no longer considered to be in compli
with GMP.
Address of Certifying authority:
Central Drugs Standard Control Organization,
FDA Bhavan,ITO ,Kotia Road,
New Delhi- 110 002
Name and Fun ti
Dr. G. N. Singh,
Drug Controller G neral (I),
Email: dc i nic.· 1
Telephone No:-\fh 11 23236965
Fax No: 91 11 23236973
(This model certificate for OMP is not part of the WHO certification scheme on the Quality of PharmaceuticalProducts
Moving in International Commerce.)
Explanatory Notes
(1) This certificate, which is in the format recommended by WHO, certifies the status of the Site listed in Point
Applicable" in case where there is no legal framework for the issuing of a licence.
(4) Table 1
Example I
Pharmaceutical
Product (s) 2
Category (ies)
Activity (ies)
Dosage Form (s):
Cytotoxic
Production
Hormone
Production ,Quality Control
& Packing
Penicillin
Repacking and Labelling
Cefalosporin
Packing, Labelling
Tablets
Injectables
Example 2
Pharmaceutical
Product (s) 2
Category (ies)
Activity (ies)
Analgesic
Paracetamol
Packing, Labelling
. .
..
2.Pharmaceutlcal Products :- Any medicine mtended for human use or vetennary product administered to food Producing animals,presented in its finished dosage for or as a starting material for use in such a dosage form, that is subject
excludingpackaging materials.
Use, whenever available, International nonproprietary Names (INNs) or otherwise national nonproprietary
Names.
(5) The certificate remains valid until the specified date. The certificate becomes invalid if the activities and lor
certificate are those included in Quality Assurance of pharmaceuticals: a compendium of guidelines and related
\
ANNEXURE
WHO
GMP Certificate
Charak Pharma
the following
Sr.
3.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
0
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
I
Valid
I 2-.8,
up to :
a..., , ?__o I b
Dist Solan,
H.P. 173205,
COPP No.
WHO/GMP/COPP/CPPUBADDI/01/20.15
WHO GMP/COPP/CPPU2013/007
WHO/GMP/COPP/CPPUBADDI/0212015
WHO/GMPICOPP/CPPUBADOI/03/2015
WHO GMP/COPP/CPPU2Q13/006
WHO/GMP/COPP/CPPUBADDI/04/2015
WHO GMP/COPP/CPPLl2013/004
WHO GMP/COPP/CPPLl2013/010
Under
Name of Product
Livornvn
Tablet
M2 Tone Tablets
Neo Tablets
Obenvl Tablets
Ostolief
Tablet
Pallarywyn
forte Tablets
Pilief tablet
Prosteez
Tablets
Re quta x Forte Tablets
Sumenta
Tablet
Vlq orn ax Forte Tablet.
License No: HP-128-Av
COPP No.
WHO/GMP/COPP/CPPUBADOI06/2015
WHO/GMP/COPP/CPPUBADDI/08/2015'
WHO/GMP/COPP/CPPUBADDI/09/·2015
WHO/GMP/COPP/CPPUBADDI/10/2015 ,
WHO/GMP/COPP/CPPLIBADDII11/2015
Countries:-
Algeria
Australia
Armenia
Austria
Argentina
Azerbahan
Bahrain
Belarus
Benin
Burkina Faso
Belgium
Brazil
Bahamas
Bangladesh
Barbados
Bolivia
Bulgaria
Botswana
Cameroon
Czech Republic
Cambodia
China
Columbia
Costarica
4.
5.
6.
C
The Nalagarh
Name of .country
No.
1.
2.
I
~/'It!/t:JI/J-ol';-
Pvt. Ltd.
Village Katha,P.O.Baddi,
Name of Product
Alsarex
Tablet
Arthrella
Tablet
Calcury
Tablet
Ceph aq r alne Tablet
COQnium Tablets
Extrammune
Tab.let
Femiforte
Tablets
Femiplex
Tablets
Fortvfitt
Tablet
Galakol
Tablets
Haleezy
Tablet
Hyponidd
Tablet
For
I CMP!t-IT\/
No.
I
CIS
Congo
Chile
Canada
Cuba
Cyprus
Dominican Republic
Denmark
Egypt
Estonia
Ethiopia
EI-Salvador
Finland
Fiji
France
Address of certifying authority:
Sr.
No.
40.
41.
42.
43.
44.
45.
46.
47.
48.
49.
50.
51.
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76.
77.
78.
Name of country
French Guiana
Gabon
Ghana
Guatemala
Georgia
Germany
Guyana
Greece
Guinea
Hungary
Hong Kong
Honduras
Haiti
Hawai
Iceland
Iran
Iraq
Ivory Coast
Indonesia
Ireland
Italy
Jordan
Jamaica
Japan
Kazakhstan
Kenya
Khyrohsztan
Kuwait
Korea
Leichestein
Lebanon
Latvia
Lithuania
Lesotho
Liberia
Libya
Luxembourg
Laos
Muscat
Sr.
No.
79.
80.
81.
82.
83.
84.
85.
86.
87.
88.
89.
90.
91.
92.
93.
94.
95.
96.
97.
98.
99.
100.
101.
102.
103.
104..
105.
106.
107.
108.
109.
110 ..
111.
112.
113.
114.
115.
116.
117.
Name of country
Malwai
Mauritius
Maldovia
Morocco
Mexico
Malaysia
Myanmar
Mauritania
Madagaskar
Maldives
Mali
Malia
Mozambique
Monaco
Mongolia
Nepal
Nigeria
Nicaragua
Norway
Netherlands
Namibia
Newzelands
Niger
Oman
Philippines
Panama
Peru
Pakistan
Papua-New Guinea
Paraquay
Portugal
Poland
Puerto Rico
Qatar
Romania
Russia
Rwanda
Sri lanka
Senegal
Sr.
No.
118.
119.
120.
121.
122.
123.
124.
125.
126,
127.
128.
129.
130.
131.
132.
133.
134.
135.
136.
137.
138.
139.
140.
141.
142:
143.
144.
145.
146.
147.
148.
~49,
150.
151.
152.
153.
154.
155.
156.
157.
Name of country
South Africa
Sudan
Singapore
Saudi Arabia
Seychelles
Seiraleone
Slovenia
Solomon Islands
Somali
Somalia
South Korea
Spain
Surinam
Swaziland
Sweden
Syria
Slovak Republic
Switzerland
Tanzania
Togo
Thailand
Thailand
Tunlsea
Taiwan
Turutky
l,JAE.
Uganda
United Kingdom
Ukraine
Uzbekistan
U.S.A.
Uruguay
Venezuela
Vietnam
Virgin Island
Yemen
Yugoslavia
Zaire
Zambia
Zimbabwe
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION,
FDA SHAVAN, ITO, KOTLA ROAD NEW DELHI-lID
C'O'2
Telephone No. :011-23236965
Tele I Fax:01'-23236973
Stamp & Date

certificate of good manufacturing practices

Transcription

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