EC-ASEAN Economic Cooperation Programme on Standards Quality and

EC-ASEAN Economic Cooperation Programme on Standards, Quality and Conformity Assessment Project co-financed by European Union Project co- financed by Asean Chöông trình hôïp taùc kinh teá veà tieâu chuaån, chaát löôïng vaø ñaùnh giaù söï phuø hôïp COSMETIC Sub-Programme Chöông trình veà myõ phaåm EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency June 2005 Eusebia A. Regodon Bureau of Food and Drugs Manila, Philippines Stephanie Wong Malaysia

Project co-financed by European Union 1. 2. 3. 4. 5. 6. 7. 8. 9. Content Noäi dung Project co- financed by Asean Quality Control Overview (Objective) Khaùi quaùt veà kieåm tra chaát löôïng (muïc ñích) Scope Phaïm vi QC Tasks Caùc coâng vieäc QC Reprocessing - Xöû lí laïi Return- Traû keát quaû Quality Control Responsibility- Traùch nhieäm cuûa kieåm tra chaát löôïng i. Calibration- kieåm ñònh ii. Sampling- Laáy maãu iii. Material Flow for QC- Ñöôøng ñi cuûa nguyeân lieäu cho QC iv. Sample Retention Program and Stability Studies in Quality Controlv. Chöông trình löu maãu vaø nghieân cöùu tính oån ñònh trong QC vi. Handling / Management of Chemical Reagents - Xöû lí/quaûn lí hoùa chaát thöû EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

KHAÙI QUAÙT QUAÛN LÍ CHAÁT LÖÔÏNG Project co-financed by European Union Project co- financed by Asean Part 1 Ñaûm baûo Muïc tieâu Saûn phaåm coù chaát löôïng oån ñònh vôùi coâng duïng ñònh tröôùc Thieát laäp heä thoáng yeâu caàu chaát löôïng Caùch laøm Saûn phaåm chöùa nhöõng vaät tö ñuùng veà chaát löôïng vaø soá löôïng Ñöôïc saûn xuaát trong nhöõng ñieàu kieän ñuùng nhö SOPs Laáy maãu Part 2 Kieåm tra vaø thöû: Nguyeân lieäu ñaàu vaøo, meû troän, baùn thaønh phaåm, thaønh phaåm Lónh vöïc then choát Chöông trình quaûn lí moâi tröôøng Chöông trình löu maãu Vaên baûn hoùa/xem xeùt döõ lieäu meû troän Kieåm ñònh Xöû lí thuoác thöû Nghieân cöùu tính oån ñònh Ñaït/khoâng ñaït: Quaûn lí vaät tö vaø thaønh phaåm EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Cheá bieán laïi Quaûn lí tieâu chuaån Quay laïi

Objective- Muïc tieâu Project co-financed by European Union Project co- financed by Asean To ensure that the quality of the material is tested* and meeting the specification before use. Ñaûm baûo vaät tö ñöôïc kieåm tra chaát löôïng vaø ñaït tieâu chuaån tröôùc khi ñöôïc ñöa vaøo suû duïng – Starting materials (Raw materials and Water) – Nguyeân lieäu ban ñaàu ( Nguyeân lieäu vaø nöôùc) – Packaging materials- Bao bì – Intermediates- Saûn phaåm trung gian – Bulk products- Saûn phaåm chôø ñoùng goùi – Finished products- Thaønh phaåm Note*: Test can be conducted by in-house laboratory or external laboratory Ghi chuù : Vieäc kieåm tra coù theå ñöôïc tieán haønh bôûi phoøng hí nghieäm cuûa coâng ty hay phoøng thuù nghieäm beân ngoøai n EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Scope- Phaïm vi Project co-financed by European Union Project co- financed by Asean The scope of QC responsibilities shall cover the following: - Phaïm vi traùch nhieäm cuûa QC bao goàm n Starting materials (Raw materials and Water)nguyeân lieäu ban ñaàu ( Nguyeân lieäu vaø nöôùc) n Packaging materials- bao bì n Intermediates- Saûn phaåm trung gian n Bulk products- Saûn phaåm chôø ñoùng goùi n Finished products- Thaønh phaåm n Environmental conditions- Caùc ñieàu kieän moâi tröôøng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

QC Activities Overview Khaùi quaùt caùc hoïat ñoäng cuûa QC Microbiology Laboratory Project co-financed by European Union Project co- financed by Asean Physical/ Chemical Laboratory Phoøng thí nghieäm vi sinh Phoøng thí nghieäm hoùa lyù Sampling-Laáy maãu Inspection & Testing Sampling- Laáy maãu Kieåm tra vaø thöû Inspection & Testing- Kieåm tra vaø thöû OOS Investigation - Ñieàu tra OOS Procedures- Qui trình Procedures-Qui trình Handling/Mgt of chemical reagents Monitoring Xöû lyù/quaûn lyù hoùa chaát thöû program Chöông trình giaùm saùt Materials Disposition Retention _ Toàn truõ Caùch saép xeáp vaät tö Batch record review -Raw Material- Nguyeân lieäu Xem xeùt hoà sô loâ -Finished product-Thaønh Pha Specification control Environment - Moâi tröôøng Kieåm soùat tieâu chuaån. Kt Stability - Ñoä oån ñònh Release/reject Calibration- Kieåm ñònh Chaáp nhaän/töø choái Procedures- Qui trình EUROPEAN COMMITTEE FOR Procedures- Qui trình STANDARDISATION - Implementing Agency

Reprocessing- Taùi cheá Project co-financed by European Union n n Project co- financed by Asean Complete OOS/Non-conformance investigation with risk assessment on recovery decision, based on approved procedure Khi coù quyeát ñònh taùi cheá phaûi hoøan taát ñaùnh giaù OOS/ khoâng phuø hôïp döïa treân qui trình ñöôïc duyeät Issue Reprocessing Instruction - Ban haønh höôùng daãn taùi cheá Approval of Reprocessing Instruction by QC personnel- Höôùng daãn taùi cheá do nhaân vieân phoøng QC duyeät EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Haøng Traû veà Project co-financed by European Union n n n Ñònh nghóa -Moïi haøng traû veà ñeàu ñöôïc coi laø bò loïai tröø khi coù ñeà nghò taùi cheá ( chaúng haïn nhö haøng thu hoài, heát haïn, hö hoûng do vaän chuyeån) Moïi haøng traû veà phaûi deã nhaän bieát vaø ñeå rieâng Phaûi coù ñaùnh giaù ruûi ro, döïa treân caùc qui trình ñöôïc duyeät, ñi keøm vôùi quyeát ñònh taùi cheá Ñieàu kieän tröng baøy, baûo quaûn, thôøi gian, haïn söû duïng phaûi ñöôïc xem xeùt trong quaù trình ñaùnh giaù Keát quaû kieåm tra cuûa Lab phaûi ñaït tieâu chuaån cuûa saûn phaåm. Quyeát ñinh cuoái cuøng ít nhaát cuõng phaûi döïa vaøo chaát löôïng lieäu coù ñaït tieâu chuaån vaø caùc qui ñònh hieän haønh Möùc ñoä khoâi phuïc neân ñöôïc vaên baûn hoùa vaø ñöôïc QC chaáp nhaän Xöû lí haøng traû veà neân döïa vaøo caùc qui trình ñaõ ñöôïc EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency n Project co- financed by Asean

Project co-financed by European Union Project co- financed by Asean CAÙC HOÏAT ÑOÄNG CUÛA QC I. III. IV. Calibration- Kieåm ñònh Sampling- Laáy maãu Material Flow for QC- ñöôøng ñi cuûa maãu cho QC Sample Retention Program and Stability Studies in Quality Control. Chöông trình löu maãu vaø nghieân cöùu ñoä oån ñònh trong QC Handling / Management of Chemical Reagents - Xöû lí/ quaûn lyù hoùa chaát EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union KIEÅM ÑÒNH LAØ GÌ? Calibration is a combination of checking an instrument and adjusting it to bring it within its limit for accuracy according to recognized standards. Kieåm ñinh laø söï keát hôïp giöõa vieäc kieåm tra vaø hieäu chænh moät thieát bò, laøm cho noù coù ñoä chính xaùc nhö caùc tieâu chuaån ñaõ ñöôïc thöøa nhaän” EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Muïc tieâu Project co-financed by European Union n n To maintain the accuracy and precision of test equipment at all times. Duy trì thieát bò kieåm tra luoân ñuùng vaø chính xaùc To ensure highest level of confidence in all measurement that affect materials disposition decision. Ñaûm baûo möùc ñoä tin caäy cao nhaát trong moïi ño löôøng maø coù aûnh höôûng ñeán quyeát ñònh söû duïng vaät tö To determine whether the equipment is still fit for its intended purpose Quyeát ñònh xem lieäu thieát bò coù coøn phuø hôïp EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency n Project co- financed by Asean

Chính saùch Project co-financed by European Union n n n Project co- financed by Asean Moãi thieát bò neân coù soá lieäu lòch söû ñöôïc löu tröõ laâu daøi Moãi thieát bò ñöôïc ñaùnh soá rieâng ( ID) Xaùc ñònh vaø duyeät phöông phaùp kieåm ñònh cho töøng thieát bò. AÁn ñònh taàn suaát kieåm ñònh cho töøng thieát bò Tieâu chuaån phaûi phuø hôïp vôùi caùc tieâu chuaån ñaõ ñöôïc thöøa nhaän Moãi thieát bò phaûi ñính keøm nhaän daïng veà tình traïng kieåm ñònh va øthôøi haïn coøn hieäu löïc Löu giöõ caùc soá lieäu veà ñaøo taïo cho nhöõng ngöôøi lieân quan ñeán kieåm ñònh EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Soá lieäu kieåm ñònh Project co-financed by European Union Project co- financed by Asean Calibration Schedules- Lòch kieåm ñònh n Calibration Certificates- Chöùng chæ kieåm ñònh n Written Calibration Procedures for each equipment (SOP’s)- Vaên baûn veà qui trình kieåm ñònh cho töøng thieát bò n EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Project co- financed by Asean Lòch kieåm ñònh Thieát bò Caân phaân tích Caân Maùy ño ñoä nhôùt Noài haáp EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Maõ soá thoâng soá caàn 01 ñöôïc kieåm troïng löôïng ñònh Taàn suaát taùi kieåm ñònh 02 troïng löôïng 1 thaùng 03 Ñoä nhôùt 6 thaùng 04 Nhieät ñoä AÙp suaát 12 thaùng 6 thaùng 12 thaùng

Chöùng chæ kieåm ñònh Project co-financed by European Union n n n Teân vaø ñòa chæ cuûa nhaø thaàu kieåm ñònh ( Nhaø thaàu ñöôïc cô quan chöùc naêng ñòa phöông caáp pheùp) Teân vaø ñòa chæ cuûa ngöôøi yeâu caàu kieåm ñònh Moâ taû, nhaän daïng cuûa thieát bò ñöôïc kieåm ñònh yeáu toá moâi tröôøng khi thieát bò ñöôïc kieåm ñònh Ngaøy nhaän thieát bò, ngaøy kieåm ñònh vaø ngaøy kieåm ñònh keá tieáp Calibration method Keát quaû kieåm ñònh Chöõ kí vaø chöùc danh cuûa ngöôøi chòu traùch nhieäm kieåm ñònh EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Project co-financed by European Union Ví duï : Qui trình kieåm ñònh chuaån Project co- financed by Asean 1. MUÏC ÑÍCH : moâ taû qui trình kieåm ñinh caân troïng löôïng 2. Phaïm vi : Giaùm saùt QC/ QC 3. Traùch nhieäm : Toå tröoâng QC, nhaân vieân chòu traùch nhieäm kieåm ñònh 4. Moâ taû quaù trình : 4. 1 Kieåm tra caân thaêng baèng : Kim hoaëc soá chæ soá 0. Neáu khoâng ñieàu chænh laïi 4. 2 Caân thöû möùc ñoä nheï nhaát baèng vaät naëng tieâu chuaån ( 10 kg) 4. 3 Tieáp tuïc caân thöû ôû möùc lôùn hôn 4. 4 Quaû caân chuaån : 10 kg; 20 kg; 40 kg; 70 kg 4. 5 Ghi cheùp keát quaû kieåm ñònh vaøo maãu 4. 6 Keát luaän töø vieäc kieåm ñònh. Caân trong tình traïng toát neáu khoâng sai leäch quaù 0. 1% so vôùi quaû caân chuaån. 5. Keát thuùc taøi lieäu EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Project co- financed by Asean LAÁY MAÃU I. Calibration II. Sampling III. Material Flow for QC Sample Retention Program and Stability Studies in Quality Control Handling / Management of Chemical Reagents IV. V. It is an important operation of quality control in which only a small fraction of batch is taken. Ñaây laø moät hoïat ñoäng quan troïng cuûa kieåm tra chaát löôïng maø chæ moät löôïng nhoû cuûa loâ haøng ñöôïc laáy maãu EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Muïc ñích Project co- financed by Asean To determine the quality of the raw material, packaging material, intermediate, bulk and finished product based on a small quantity tested. n Ruùt ra chaát löôïng cuûa nguyeân lieäu, bao bì, baùn thaønh phaåm, Saûn phaåm chôø ñoùng goùi, thaønh phaåm töø vieäc thöû moät soá löôïng nhoû n EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Chính saùch chung veà laáy maãu Project co-financed by European Union n n n n Project co- financed by Asean Ñaùnh daáu thuøng ñaõ ñöôïc laáy maãu Neân coù moät phöông phaùp laáy maãu ñöôïc duyeät Nhaân vieân laáy maãu caàn ñöôïc ñaøo taïo kó löôõng Thieát bò/duïng cuï laáy maãu phaûi saïch Maãu ñöôïc laáy phaûi ñaïi dieän cho loâ haøng/meû haøng Khu vöïc laáy maãu phaûi saïch Haïn cheá laây nhieãm cheùo Taêng cöôøng chuù yù vôùi nhöõng chaát khoâng oån ñònh Maãu phaûi coù nhaõn ghi roõ raøng – – Teân Soá loâ Ngaøy laáy maãu Chuõ kí vaø nhaän daïng cuûa ngöôøi laáy maãu EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Söï chaáp nhaän keá hoïach laáy maãu Project co- financed by Asean Sampling shall be performed on each receiving batch - Maãu ñöôïc laáy cho töøng loâ haøng n Acceptance sampling plan shall be based on either of the following rules based on each manufacturer’s batch: Söï chaáp nhaän keá hoïach laáy maãu ñöôïc döïa vaø moät trong hai nguyeân taéc döôùi ñaây, tuøy thuoäc vaøo loâ cuûa nhaø saûn xuaát n – Sampling plan: {SQRT (N)} + 1 – Attribute sampling plan: ANSI Z 1. 4 -1993 EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Chính sach laáy maãu cho: Project co- financed by Asean 1. 2. 3. 4. EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Raw Materials- nguyeân lieäu Packaging Materials- Bao bì During Production and Filling- trong quaù trình saûn xuaát vaø chieát roùt Water and Environment Air Quality- Chaát löôïng nöôùc vaø moâi tröôøng

Caùc kieåu naép ñaäy tieâu bieåu cuûa nguyeân lieäu Project co-financed by European Union EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Chính saùch laáy maãu cho nguyeân lieäu Project co-financed by European Union n n Vôùi nhöõng kieän haøng lôùn, laáy maãu ñaïi dieän töø treân, giöõa vaø döôùi Bình chöùa maãu ñöôïc daùn nhaõn roõ raøng Ñaùnh daáu kieän haøng ñaõ ñöôïc laáy maãu Ñaøo taïo cho nhaân vieân laáy maãu Maãu ñöôïc laáy trong moâi tröôøng saïch EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Chính saùch laáy maãu bao bì Project co-financed by European Union Project co- financed by Asean Ít nhaát löu yù ñeán caùc ñieàu sau: u u Soá löôïng ñaõ nhaän Soá löôïng yeâu caàu Baûn chaát cuûa nguyeân lieäu ví duï ñöôïc in hay khoâng ñöôïc in Soá löôïng laáy maãu ñöôïc ghi roõ trong keá hoïach laáy maãu EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Chính saùch laáy maãu trong saûn xuaát, chieát roùt, ñoùng goùi Project co-financed by European Union Saûn xuaát/cheá bieán saûn phaåm thoâ n Baûo ñaûm nôi laáy maãu ñöôïc xaùc ñònh n Duïng cuï laáy maãu phaûi saïch tröôùc khi duøng n Vaät chöùa maãu phaûi ñöôïc ghi nhaõn : teân saûn phaåm, ngaøy saûn xuaát, soá loâ, ngaøy laáy maãu, ngöôøi laáy maãu n Nhaân vieân laáy maãu ñöôïc ñaøo taïo n Moâi tröôøng laáy maãu phaûi saïch chieát roùt, ñoùng goùi Thaønh phaåm q Laáy maãu löu cho giai ñoïan naøy EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Project co-financed by European Union Chính saùch laáy maãu cho TN vi sinh Project co- financed by Asean n n EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Water Quality Chaát lööïong nöôùc Environment Air Quality Chaát löôïng moâi tröôøng khoâng khí

Laáy maãu nöôùc Project co-financed by European Union n n Project co- financed by Asean Laáy maãu taïi nôi söû duïng, bao goàm caû nhöõng voøi thoâng thöôøng ñöôïc duøng ñeå laáy nöôùc ñònh kì, ví duï 1 tuaàn moät laàn. Söû duïng thuû thuaät voâ khuaån : – Tieät truøng chai laáy maãu – Veä sinh ñieåm laáy maãu vôùi 70% IPA – Göõ maãu trong tuû laïnh tröôùc khi test ( <24 giôø) hoaëc test ngay laäp töùc EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Laáy maãu moâi tröôøng khoâng khí Project co-financed by European Union Project co- financed by Asean n Laáy maãu khoâng khí taïi nôi maø nguyeân lieäu thoâ vaø saûn phaåm thoâ ñöôïc môû ra nhö khu vöïc saûn xuaát n Sau ñaây laø moät soá thuû thuaät phöông phaùp laáy maãu n Settling Plate – a petri dish of tryptase soy agar or other suitable medium is placed lid off in the sampling area. After a specified time, the plate is collected, incubated and the colonies are counted. – Slit to agar – particles are impinged directly on an agar plate. Air is drawn through slit by vacuum. The speed of the plate rotation and the volume of air sampled maybe adjusted. After incubation of the plate, the number of viable particles per unit of time may be determined. – Centrifugal Air Sampler – air is collected via centrifugation through impeller blades and impacted onto the surface of a nutrient agar medium contained in a prepared strip. The strip is then removed, incubated and the number calculated. EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union QUALITY CONTROL 2. Calibration Sampling 3. Material Flow for QC 4. Sample Retention Program and Stability Studies in Quality Control Handling / Management of Chemical Reagents 1. 5. EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

ÑÖÔNG ÑI CUÛA MAÃU CHO QC Project co-financed by European Union Project co- financed by Asean Vaøo soå maãu laáy ñöôïc Test maãu (theo thuû tuïc test ñöôïc duyeät) Vaøo soå ghi cheùp cuûa lab keát quaû kieåm tra Ñaït tieâu chuaån YES Chuaån bò phaùt haønh Co. A EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Daùn nhaõn chaáp nhaän ñeå ñöa vaøo söû duïng Heát NO Tìm hieåu nguyeân nhaân khoâng ñaït hoaëc khoâng phuø hôïp Chuaån bò baùo caùo- Daùn nh khoâng chaáp nhaän vaø ñeå vaøo moät khu rieâng.

Project co-financed by European Union Muïc ñích Project co- financed by Asean To ensure all tested materials are consistently meet the specification n Ñaûm baûo moïi vaät tö ñöôïc kieåm tra ñeàu ñaït tieâu chuaån moät caùch oån ñònh n EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Chính saùch löu maãu Project co-financed by European Union I. III. Calibration Sampling Material Flow for QC IV. Sample Retention Program and Stability Studies in Quality Control I. Handling / Management of Chemical Reagents Soá löôïng maãu löu ít nhaát gaáp ñoi soá löôïng caàn thieát ñeå tieán haønh ñaày ñuû caùc test/kieåm tra ñeå ñaùnh giaù chaát löôïng saûn phaåm ( ví duï khi coù khieáu naïi) Thôøi gian löu maãu thöôøng daøi hôn 1 naêm so vôùi haïn söû duïng ví duï neáu haïn söû duïng laø 3 naêm thì thôøi gian löu maãu laø 4 naêm EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Chính saùch nghieân cöùu ñoä oån ñònh Project co-financed by European Union I. III. Calibration Sampling Material Flow for QC IV. Sample Retention Program and Stability Studies in Quality Control I. Project co- financed by Asean Handling / Management of Chemical Reagents nghieân cöùu tính oån ñònh bao goàm caùc daïng bao bì nhö chai, bình, oáng aêm pun, goùi nhoû. Nhö laø moät phaàn cuûa nghieân cöùu, tính töông thích giöõa bao bì vaø vaät chöùa beân trong cuõng caàn phaûi ñöôïc xem xeùt Nghieân cöùu ñoä oån ñònh neân chieám moät phaàn nhoû trong toøan boä tuoåi thoï cuûa saûn phaåm baèng caùch nghieân cöùu taêng cöôøng hoaëc nghieân cöùu thôøi gian thöïc EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Chöông trình nghieân cöùu ñoä oån ñònh Project co-financed by European Union A program designed in order to: Chöông trình ñöôïc thieát keá ñeå: n To assess the stability characteristics of products n Ñaùnh giaù ñaëc tính oån ñònh cuûa saûn phaåm n To determine storage condition n Quyeát ñònh ñieàu kieän baûo quaûn n To determine expiration date n Quyeát ñònh haïn duøng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Project co-financed by European Union CHÖÔNG TRÌNH LÖU MAÃU VAØ NGHIE N CÖÙU ÑOÄ OÅN ÑÒNH TRONG QC Project co- financed by Asean Chöông trình ñöôïc soïan thaûo phaûi ñöôïc tuaân thuû vaø bao goàm Xaùc ñònh kích côõ maãu, taàn suaát thöû vaø ñieàu kieän baûo quaûn n n Phöông phaùp test ñöôïc duyeät Test saûn phaåm trong bao bì nhö laø noù ñöôïc baùn treân thò tröôøng Moät nghieân cöùu tính oån ñònh ñöôïc thöïc hieän trong nhöõng ñieàu kieän sau : : n Saûn phaåm môù ( thöôøng thöû trong meû saûn xuaát pilot n bao bì môùi khaùc vôùi bao bì tieâu chuaån thoâng thöôøng n Thay ñoåi coâng thöùc , phöông phaùp gia coâng cuûa nguyeân lieäu ñaøu vaøo, n Saûn phaåm ñöôïc ñöa ra thò tröôøng ñeå khaúng ñònh thôøi EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union NGHIE N CÖÙU ÑOÄ OÅN ÑÒNH Project co- financed by Asean u. Real time stability is carried out at actual room temperature throughout the shelf life of the product. Nghieân cöùu tính oån ñònh thôøi gian thöïc ñöôïc tieán haønh vôùi nhieät ñoä phoøng vaø trong suoát thôøi haïn söû duïng saûn phaåm EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union XÖÛ LÍ/QUAÛN LÍ HOÙA CHAÁT THÖÛ Moïi hoùa chaá, thuoác thöû phaûi coù nhaõn ghi caùc thoâng tin sau: u u u Teân cuûa hoùa chaåt Noàng ñoä hoaëc ñoä maïnh Ngaøy heát haïn Ngaøy pha cheá Ngöôøi pha cheá Baûng An toaøn nguyeân lieäu (MSDS) EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean

Project co-financed by European Union Project co- financed by Asean Moïi hoùa chaát thöû bao goàm caû dung moâi duøng trong caùc test vaø thí nghieäm phaûi coù chaát löôïng ñaûm baûo töø caùc nhaø saûn xuaát va cung caáp danh tieáng u Hoùa chaát thöû phaûi ñöôïc daùnh nhaõn caån thaän vaø löu giöõ tuaân thuû caùc qui ñònh an toøan. Neân kieåm keâ ñònh kì ñeå quaûn lí soá löôïng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Project co- financed by Asean n n u u u n n Dung dòch ñeå ño theå tích phaûi ñöôïc daùn nhaõn ñaày ñuû Caån thaän traùnh nhieãm khuaån trong quaù trình cung caáp, söû duïng vaø baûo quaûn. Caát hoùa chaát thöû ôû nôi thoâng thoùang khoâ raùo, traùnh nhieät ñoä cao vaø nôi coù tia löûa ñieän Löu rieâng chaát deã chaùy vaø chaát khoâng deã chaùy , löu yù ñeán tính töông thích giöõa caùc hoùac chaát ñeå ñeà phoøng nguy cô maát an toøan Acids khoâng bao giôø ñöôïc ñeå treân giaù cao hoaëc ñeå treân caùc chaát hoïat ñoäng Khoâng aên uoáng hoaëc huùt thuoác khi tieáp xuùc söû duïng hoùa chaát Göõ an toøan hoùa chaát töø nguoàn ñöôïc cho pheùp EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Ñieàu kieän chaáp thuaän Project co-financed by European Union n Project co- financed by Asean nguyeân lieäu thoâ – Döïa vaøo vieäc so saùnh Co. A cuûa nhaø saûn xuaát vaø tieâu chuaån ñaõ ñöôïc duyeät – Bao bì ngoøai : Khoâng roø ræ, moùp meùo raùch vôõ, coøn nguyeân nieâm phong – Coù nhaõn maùc deã ñoïc coù daáu hieäu nhaän bieát vaø soá loâ – Taàn suaát : Moãi meû cuûa nhaø saûn xuaát moãi laàn giao haøng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union n Ñieàu kieän chaáp thuaän Project co- financed by Asean Nöôùc cho saûn xuaát – Nöôùc uoáng theo tieâu chuaån quoác gia coù theå söû duïng ñeå saûn xuaát myõ phaåm vaø lau röûa thieát bò – Vieäc xöû lí nöôùc uoáng tuøy thuoäc vaøo muïc ñích söû duïng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union n Ñieàu kieän chaáp thuaän Project co- financed by Asean Process Water for other categories: – Test parameters and frequency shall be based on its intended purpose – Nöôùc cho saûn xuaát caùc loaïi saûn phaåm khaùc: Caùc thoâng soá kieåm tra vaø taàn suaát ñöôïc döïa vaøo muïc ñích söû duïng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Ñieàu kieän chaáp thuaän Project co-financed by European Union n Project co- financed by Asean Bao bì – Döïa vaøo Co. A cuûa nhaø saûn xuaát vaø so saùnh vôùi tieâu chuaån ñöôïc duyeät – Bao bì ngoøai : Khoâng roø ræ, moùp meùo raùch vôõ, coøn nguyeân nieâm phong – Coù nhaõn maùc deã ñoïc coù daáu hieäu nhaän bieát vaø soá loâ – Taàn suaát : Moãi meû cuûa nhaø saûn xuaát moãi laàn giao haøng EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Ñieàu kieän chaáp thuaän Project co-financed by European Union n Project co- financed by Asean Saûn phaåm thoâ/ thaønh phaåm – Döïa vaøo Soá lieäu meû saûn xuaát ( BMR) vaø thoûa maõn tieâu chuaån cuûa saûn – Moãi loâ cuûa nhaø saûn xuaát n Saûn phaåm dôû dang: – Nhö tieâu chuaån cuûa nhaø saûn xuaát EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union Ñieàu kieän chaáp thuaän Project co- financed by Asean Stability Study n Nghieân cöùu tính oån ñònh n – Based on manufacturer internal procedure and standard – Döïa vaøo tieâu chuaån vaø thuû tuïc noäi boä cuûa nhaø saûn xuaát – Trending of result to determine the characteristic of the product – Xu höôùng cuûa keát quaû ñöôïc quyeát ñònh bôûi ñaëc tính cuûa saûn phaåm EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency

Project co-financed by European Union EUROPEAN COMMITTEE FOR STANDARDISATION - Implementing Agency Project co- financed by Asean