لوازم آرایشی
TRANSCRIPT
5831
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GMP
PMF
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Cosmetics Detergents Disinfectants Pesticides Free Sales Certificate Health Certificate
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: (7) PMF
.: (8) GMP ) (9)(QA .
7- Plant &Product Master File 8- Good Manufacturing Practices 9- Quality Assurance
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5831
)( )( :1- ) ( 2- ) ( ) 2( 3- : 3 -1( 3-2( ) ( 3-3( 3-4( ) ( 3-5( 3-6( 3-7( 3-8( 4- 5- ) 3 ( ) 3 ( 6- ) ( : 6-1( 6-2( ) ( 6-3( . 6-4( Data Safety Sheet
:1- ) .( 2- ) 3( 3- . 4- ) 1( 5- . : . 6- ) ( ) ( Result . : . 7- ) ( 8- 9- . 01- . : 1- . 2- .
. . 1 2 3 4 2 BSE1/TSE " 5 ... ) ( .
: : 1( . 2( . 3( . 4( .
1.BSE=Bovine Spongiform Encephalopathy 2.TSE=Transmissible Spongiform Encephalopathy
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5831
: :1- ) ( 2- )31( 3 - 00000045 ) ( 86/1241 . 4- ) 9 ( ) ( ) 91 ( 3831 . 1 : ) ( . 2: . 5- ) 21( 6- 7- : 7-1( ) ( GMP )1( ) ( ) ( . 7-2( PMF ) - Plant & Product Master File 2 ( VCD ) ......... ( 1: VCD . 2: )5-1( )5-2( PMF .
3: 7 ) GMP PMF VCD ( : 1- 2- 3- 4- 5- ) ( 6- 7- 8- 9- 01- 8- )3 (
: :1- ) ( 2- ) 41( 3- ) ( 4- ) 4( 5- 6- ) 21 ( 7- ) ( 6 . : . ) 6( 8- : ) 7( ) ( ) ( / ) ( 9- 6 01- 0000009 ) ( 86/1241 ) 8( 11- ) 9( 1 : 4 7 . 2: 7 .
: ) ( :
1 ) ( 2 )( .)51( 3 : 3-1( 3-2( 3-3( 3-4( ) ( 3-5( 3-6( 4- . 5- . 6- ) ( 7 . 8 ) (. 9- ) ( : 6 8 7 .
: :1 ) . ( 2 .) 61( 3 : 3-1( 3-2( 3-3( 3-4( ) ( 3-5( 3-6( 3-7( ) ( . 4 PACKING LIST . 5 .) 5( 6 . ) 3/2 (. 7- ) (. 8- . 9- . 01- . 11- ) ( 21- 31- . ) (.
41- ) (. 51- .
:1 . 2 . 3 01112141 . 4- 1121 31 . 5 01 .
11 ) ( .
: 1- : 1-1( )2 ( 1-2( 1-3( 1-4( 1-5( 1-6( : .
2- : 2-1( 2-2( )2 ( 2-3( 2-4( : 1-4( 1-5( .
GMP Countries Types of Certification &Its Recognized Bodies GMP by TGA (Therapeutic Good Administration) Australia GMP by Australian CTFA GMP by Belgium Ministry of Public Health Belgium DETIC Canada GMP by CCTFA (Canadian Cosmetic ,Toiletry and Fragrace Association) Self-Issued GMP Endorsed by the F.I.P (Federation Des Industries de la Parfumerie) Self-Issued GMP Endorsed by the I.K.W.(Industrieverband Koperflege Und Waschmittel e.v) the German Cosmetic, Toiletry,Perfumary and Detergent Association Manufacturing License by the Prefectural Government GMP by Health Inspectorate Netherlands N.C.V(Nederlandse Cosmetica Vereniging) Self-Issued GMP Endorsed by Lakemedelfverket (Ministry of Health) Sweden K.T.F (Kemisk-Tekniska Leverantor for Boundet) Self-Issued GMP Endorsed by International Office for the Control of Medicines Self-Issued GMP Endorsed by Kantonales Laboratorium Aargau Switzerland GMP by Swiss Agency for Therapeutic Products S.K.W (Schweizerischer Kosmetik Und Waschmitt Elverband) GMP by US CTFA USA General GMP Statement by City/State Health Department United Kingdom Self-Issued GMP Endorsed by the Department of Trade Industry(DTI)
France
Germany
Japan
2
PMF
Plant Master File(All of the documents must be translated in English)1. Name and address of the site 2. Type of products manufactured 3. Brand name of the product 4. Personnel - Personnel qualifications, experience and responsibilities of key quality personnel -Training Programme 5. Building and facilities - Administration - Description of manufacturing areas - Material storage and warehousing - Laboratories - Water system - Cleaning and sanitation 6. equipments - Production - Quality control laboratories -R & D - Maintenance - Qualification, validation and calibration - Cleaning and sanitation 7. Documentation & Certificates - Preparation revision and distribution of documents - Copies of all of the approvals & certificates -The list of the countries that these products have been exported to them
- Submitting the name and the country of the raw material suppliers of the factory. 8. Production - Description of the production operation - Handling of starting materials, packaging materials, finished
Products, quarantine, release and storage - Handling of rejected materials - In-Process sampling procedures and controls - Final product sampling procedures and controls - Reprocessing - Description of general policy for process validation - Packaging - Labeling 9. quality control - Description of the quality control system - The list of instruments available in the quality control laboratory
and control during processing laboratory (if applied) - Samples at the blank forms used in different stages of the quality control (English language) 10. Distribution, Complaints and product recall - distribution procedure - Handling of complaints and product recall 11. Contract production and analysis - Assessment of GMP compliance of the contract manufacturer 12. A brief explanation of the monitoring the site by the authorities of the country.
Product Master File1. description of manufacturing process and its flow chart 2. specification and standard analytical used for acceptance and release of -Raw materials - In process control - Final product 3. packaging material 4. labeling 5. Stability - General test methodology - Specification and test procedure - Storage test conditions - Testing frequency
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........ ( PMF VCD GMP 1-1( 1-2( 1-3( 1-4( 1-5( 1-6( 1-7( 1-8( 1-9( 1-01( 2- 3-
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1 GSP2 GDP : ) .. ( Recall 4-1( 4-2( 4-3( 4-4( 4-5( 4-6(
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) 1 ( ) ( . . 6-4( 6-5( 6-3( 6-1( 6-2(
5-
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1 : GOOD STORAGE PRACTICE
2 : GOOD DISTRIBUTION PRACTICE
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) (CFS . : . : 1- 2- 3- : .
. . 1 2 3 4 2 BSE1/TSE " 5 ... ) ( .
: : 1( . 2( . 3( . 4( .
1.BSE=Bovine Spongiform Encephalopathy 2.TSE=Transmissible Spongiform Encephalopathy
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1- 2- 3- 4- 5- 6- 7- 8-
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1- ) ( 2- 3- 4- ) ( 5- } ) ( { : . 6- ) ... ( 7- : . 8- 9- 01- 11- : . 21- 31-
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"" "" 41 5831 0000009 ) ( 86/1241 .
1- ) Loose Powder (.... Concealer 2- ) ...( 3- ) ( 4- : ) ....( 5- : ) .... ( 6- 7- ) .... ( 8- ) .... ( 9- : ... 01- 11- ) .... ( 21- ) ) ( ( 31- 41- ) .....( 51- . 61- . 71- 81- 91- ) (
1- After Shave 2- 3- 4- 5- ) .... ( ) ( Soap Bar 6- 7- 8- ) 1 ( .... 2 In 9- ) .... ( 01- ) .... ( 11- 21- ) ........ ( 31- ) ...... ( 41- ) ... ( 51- ) ... ( 61- ) ... ( 71- ) ....... ( 81- 91-
1- ) . ( 2- ) ( 3- ) ( 4- ) ( 5- ) (
1- ) ... ( 2- ) ( ....... 3- ) ... ( ) .... ( 4-
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.1- . 2- . 3- . 4- . 5- . 6- . 7- . 8- . 9- Box Pellet . 01- . 11- . 21- . 31- . 41- - 50cm - 20cm . 51- . 61- . ) ( 71- . 81- .... . 91- .... . 02- ) ( ... .
6 3 01 6 21 21 6 6 6 21 6 21 21 21 6 21 6 21 6 6 6
3 3 5 3 6 6 3 3 3 6 3 3 6 6 3 6 3 6 3 3 3
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1 2 3 4 5 6 7 8 9 01 11 21 31 41 51 61 71 81 91 02 12
3 3 3 6 21 21
3 3 3 3 6 6
After Shave
22 32 42 52 72 82
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5831-
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1- 1-1( 1-2( FDA ) (Colour index=C.I EEC . : ) ( . 1-3( : 1-3-1( ) ... ( 1-3-2( ) ( surface active agents ... 1-3-3( 1-3-4( 1-3-5( 1-3-6( ) ( 1 -3-7( 1-3-8( UV .
2 - ) Specification( ) Result ( Result . : Result ) ( . 2-1( ) ( ) ( . 2-2( . 2-3( . 2-4( ) ... ( . 2-5( : 2-5-1( ) ( total count 2-5-2( ) ( coli form 2-5-3( ) ( Pseudomonas Aeruginosa 2-5-4( ) ( Staphylococcus Eros 2-5-5( ) ( Mould 2-5-6( ) ( yeast : .
3 - SPF :3-1( SPF SPF . 3-2( ) ( . : .
4- : .
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) ( ) ( : 1( PH 2(
: 1( PH 2( ) (
: 1( 2( 40c 3(
: 1( PH 2( 3( ) (
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: 1( . 2( ) PH PH.( 3( .
) (
: 1( ) 2(O2 H2O 2( PH 3( ) (
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: 1( 2( PH 3(
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: 1( )(TFM 2( NaOH 3( ) ( 4( ) ( 5( 6( ) ( : ) ( 2 . .
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) ( . : 1( PH 2( 3(
1 . 2 . 3 : 3-1( 3-2( PH 3-3( Chlostridiom SPP .
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1 (Relative Dentine Abrasivity) RDA . 2 . 3 : 3-1( 3-2( ) ( 3-3( PH 3-4(
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1 ) ( . . 2 . 3 : 3-1( ) ( 3-2( 3-3( ) ( 3-4( PH 3-5( 3-6( 3-7( 10/0 ) ( 3-8 ( : 3 . .
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1- 1-1( . 1-2( . 2- . 1 : ) (hygienic . 2 : .
3- : 3-1( 3-2( 3-3( 3-4( 3-5 ( 3-6 ( PH 3-7 ( : 3 . .
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1 ) ( 1: . 2: . 2 : 2-1( 2-1-1( . 2-1-2( . 2-1-3( . 2-1-4( : 2- 1-4-1( n 05 % 12 CFR 0851/771 EEC . 2-1-4-2( n )( CFR 12 0251/771 EEC . 2-2 ( 2-2-1( 2-2-2( 2-2-3( PH 2-2-4( ) (
2-2-5( 2-2-6( : 2 )2-1-4( )2-2-6( . .
1 ) ( )(. 2 .
1 ) (. : . 2 : 2-1( ) (Endrounding 2-2( . 2-3( . 2-4( 2-5( .
: 2 . .
1- 2- 2
3- Safety 05 (Oral, Dermal) LD 105 LD 05 LC 05 (Inhalation) LC .
: 05 LD 05% 05 05 LC 05% 05 . 4- 5- . : 4 .
1. LD50=Dose required to kill 50%of test organism 2. LC50= Concentrate required to kill 50%of test organism
: 1- mg / Kg : 2-
: 1- 2- . 3- : 3-1( 3-2( 3-3( ) ( 3-4( ) ( 3-5(
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1. : 2. : 3. : 4. : 5. : 6. : - - - - - 7. : Low Level Intermediate Level
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01. : ) ( )1 )2 )3 )4 )5
11. : ) 1CAS .(
21. : Chlorine and Chlorine Compounds Chlorine Dioxide Iodophore and Iodophore Compounds Peroxygen Compounds Ozone Compounds Alcohols Phenolic Compounds Chlorhexidine Glutaraldehyde Quaternary Ammonium Compounds Others 31. 2 FDA ..... : ) .( 41. 3 EPA : ) ( 51. : ) MIC .( ( Static ( Static Cidal ( Static ( Static ) Cidal ) 1- :4
( : }{Staphylococcus Aureus Cidal Cidal 6 VRE ) ( : }{Enterococcus
( : } ) {Sterptococcus 5 MRSA ( :
( Static ( Static ( Static Cidal ( Static ) Cidal
Cidal Cidal
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2- : ( :
( ) ( : ) ( : Cidal ) 3- 6:TB
( Static ( Static Cidal )
: 8MDR-TB Cidal 9 HBV ) 4- : 5- :
( Static - 11HIV 01HCV
6- : 7- : Prion 61. :
71. ) 21 ppm log reduction ( :
81. : ........................................ PH .................................... ................................... .............................. .................................
91. ) (: 02. :
12 . :
22. :
32.
42. :
52. :
62. :
72. :
:28.Shelf Life :29.Use Life
82. : ) ( ) (
92. ) .............(
(. Compatibility ) :03. :13. :23. :33. :43.
. :
1.CAS= Chemical Abstract Service 2. EPA= Environmental Protection Agency 3 .FDA= Us Food And Drug Administration 4.MIC= Minimum Inhibitory Concentration 5.MRSA=Methicillin Resistant Staphylococcus Aureus 6.VRE=Vancomycin-Resistant Enterococci 7.TB=Tuberculosis 8.MDR TB=Multidrug Resistant Tuberculosis 9.HBV=Hepatitis B Virus 10.HCV=Hepatitis C Virus 11.HIV=Human Immunodeficiency Virus 12. ppm =part per Million
Safety Data Sheet1- / : 42 ) / / (
2- :
3- : )3(Kg/m PH
4- . 5- :
6- :
7- :
8- :
9-
01- :
11- : 21- : ) (
31- :
41- : ) (
51- :
61- : EEC
71- ) : (Regulatory I
81-