Inspection Guide for Excipients

Ukuhlolwa kwezesekeli kufanele kusetshenziswe ngokuhambisana nomhlahlandlela wokuhlola izindwangu. Imikhiqizo yezesekeli kulolu daba ihlanganisa izikhwama, izigqoko, amabhande, izikhafu, amagilavu, othayi, izikhwama zemali kanye namakesi ayisihluthulelo.

Mindawo yokuhlola

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·Ibhande

Ukuthi ubude nobubanzi bunjengoba bucacisiwe, noma imbobo ye-buckle ne-buckle iyahambelana, yonke imiphetho, ikhwalithi yomsebenzi, njll.

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· Isikhwama

Umumo, isikhundla kanye nekhwalithi yelogo, umsebenzi, ikhwalithi yezinto zokwakha kanye nokwenziwa, njll.

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· Amagilavu

Qhathanisa izingxenye ezingakwesokunxele nezingakwesokudla zepheya ngalinye lamagilavu ​​(umumo, ukuklama, ukuthungwa, ubude nokwehluka kombala), ikhwalithi yomsebenzi kanye nomsebenzi, njll.

Ukuhlukaniswa kwesici

1. Ukulebula, Ukumaka, Ukuphrinta (Ukupakishwa Kwentengiso kanye Nemikhiqizo)

(1) Imikhiqizo ethengiswa ezimakethe zaseYurophu nezaseMelika: alukho ulwazi ngokuqukethwe kwefayibha - amaphutha amakhulu

(2) Ulwazi losayizi olulahlekile noma olungalungile oluthunyelwa e-United States - amaphutha amakhulu

Ulwazi losayizi olungekho noma olungalungile lokuthunyelwa eYurophu - iphutha elincane

(3) Imikhiqizo ethengiswa emakethe yase-US: alikho izwe lolwazi lwemvelaphi—amaphutha amakhulu

(4) Imikhiqizo ethengiswa emakethe yase-US: alikho igama lomkhiqizi/inombolo yokubhalisa (isebenza kuphela ezindwangu noma emikhiqizweni esongwe ngezindwangu zendwangu) – amaphutha amakhulu

2. Izinto zokwakha

(1) Isikhutha – isici esibulalayo

(2) Izindwangu ezilimele, imigwaqo emincane, amaphrofayili anemibala, izinaliti ezilahlekile, njll. - amaphutha amakhulu

(3) Ukuzwakala kwesandla kuhlukile kusampula esayiniwe yekhasimende noma isampula yombala – isici esiyinhloko

(4) Ukuqina okungahambisani okubangelwa ukuklwejwa okungafanele - amaphutha amakhulu noma amancane

(5) Izimpawu zokulunywa yizinambuzane - amaphutha amakhulu noma amancane

(6) Ukukhubazeka kwePlastiki – Amapayipi (ama-burrs amancane), umlomo wombhobho ongacacile, ukugcwaliswa okunganele (ukuntuleka kwempahla), amabala ashumekiwe, amamaki okuncinza, izimpawu zokugeleza, amachashaza amhlophe, amachashaza ayisiliva, izimpawu zenaliti, ukuklwebheka kwesikhunta – isici esikhulu noma esincane

(7) Ukungafani kokwakheka - amaphutha amakhulu noma amancane

(8) I-Frizz yesikhumba - amaphutha amakhulu noma amancane

(9) Ukwakheka okuhlukile - amaphutha amakhulu noma amancane

3. Izesekeli (izinkinobho, ama-snap, izigxobo, ama-rivets, oziphu, amabhande, izingwegwe)

(1) Ukuphuka, izikhala - amaphutha amakhulu noma amancane

(2) Ibhondi engafanele, i-lamination, ukushisela noma ukuqinisa/ukuxega - amaphutha amakhulu noma amancane

(3) Ukufakwa okukhubazekile noma okuphukile okungahlangabezani nezidingo - amaphutha amakhulu noma amancane

(4) Ukunyakaza okungahambi kahle/ukukhubazeka kokusebenza ezindaweni ezinyakazayo - amaphutha amakhulu noma amancane

(5) ama-fasteners axekethile - amaphutha amakhulu noma amancane

4. Inqubo yokukhiqiza

(1) Ukufekethiswa

Isimo esibi noma ukukhiqizwa kwelogo - amaphutha amakhulu

Izinga eliphansi le-embroidery stitches - amaphutha amakhulu noma amancane

(2) Ukunyathelisa

·Iphethini ayihlangabezani nezidingo - isici esiyinhloko

· I-asymmetry yephethini – amaphutha amancane

(3) Sika

Ukusikwa Kwendwangu Egobile/Esontekile - Ukungapheleli Okuncane

(4) I-Suture

·Imigqa yokunqamuka - amaphutha amakhulu noma amancane

· Umsebenzi wokuthungatha – amaphutha amakhulu noma amancane

· I-Seam ixege (ukushelela komthungo) / ukuqhuma / ungqimba olungezansi oluveziwe – amaphutha amakhulu

·Imbobo yokubhoboza / imbobo yokubhoboza – isici esikhulu

5. Umhlangano

(1) Kukhona igebe ekuhlanganyeleni - iphutha elikhulu noma elincane

(2) Ukufakwa endaweni okuhlangana kuyo kuhlelwa ngokungalingani - amaphutha amakhulu noma amancane

(3) I-welding engalungile emaphethelweni e-seam - amaphutha amakhulu noma amancane

(4) Indandatho yebhande incane kakhulu ukuthi ingadlula - isici esiyinhloko

(5) Ukugudluka kwemithende/i-lattice/ukuphrinta - isici esiyinhloko

(6) Indlela yokufaka amapheshana ayilungile

6. Ukubukeka

(1) Ukungqubuzana okukhulu/ukungahlangani kombala, ukuma, ukuphrinta nezinye izinto - amaphutha amakhulu

(2) Ukungahambisani/ukungahambisani kombala, ukuma, ukuphrinta nezinye izinto - amaphutha amancane

(3) Indawo engalingani - amaphutha amakhulu noma amancane

(4) Ukuma kokuphela kwebhande akukuhle - isici esiyinhloko

(5) Ukuklwebheka, izibazi zamazinyo, ukuba mhlophe, ama-smudges, izinhlayiya, izintuli, ukungcola, izimpawu zokusha, izimpawu zokunamathisela ezibonakala kude nengalo – izinkinga ezinkulu noma ezincane.

Ukuqinisekiswa kwenkundla nokuhlola (ukuqinisekiswa kwendawo kungasebenza)

1. Ukulinganisa usayizi wendwangu

Inombolo yamasampuli:

Isampula yesilinganiso sosayizi ngamunye izingcezu ezi-4. Ngomkhiqizo wosayizi owodwa: Usayizi wesampula wokulinganisa usayizi Izinga 2 Lokuhlola Okukhethekile (S-2)

Izidingo zokuhlola:

Hlola uqhathanisa nezidingo ezinikeziwe noma ulwazi oluyi-dimensional kumpahla yokupakisha yomkhiqizo.

Uma ikhasimende lingakunikezi ukubekezelelana, sicela usebenzise ukubekezelelana kwephuzu lokuhweba, futhi kuthebula lesilinganiso sombiko, shintsha “ukubekezela” kube “ukubekezelelana kwamaphuzu okuhweba”. Uma inani lamaphoyinti obukhulu elidlula ukubekezelelwa kwephoyinti lokuhweba lingaphezu kuka-10% yenani eliphelele lamaphoyinti obukhulu obulinganisiwe, umphumela wokuhlolwa uzonqunywa ikhasimende.

Imibandela Engafanelekile:

Uma, ngosayizi owodwa, wonke amasampula akaliwe ephelelwe ukubekezelela endaweni eyodwa yobukhulu. Kuphakathi kokuthi inombolo yamaphoyinti obukhulu obungabekezeleleki ingaphezu kuka-10% yenani eliphelele lamaphoyinti obukhulu obulinganisiwe, noma uma, ngosayizi owodwa, isampula elilinganisiwe linyuswa futhi kutholakala ukuthi ngaphezu kuka-50% amasampula awekho ukubekezelelana endaweni yobukhulu.

2. Ukuhlolwa kwesisindo somkhiqizo:

(Leli sheke lidingeka kuphela uma kunesidingo sesisindo somkhiqizo noma uma ulwazi lwesisindo somkhiqizo luvezwe ezintweni zokupakisha).

Inombolo yamasampuli:

Inani elifanayo lamasampuli njengesilinganiso sosayizi womkhiqizo, sebenzisa usayizi wesampula ofanayo ukuhlola isisindo.

Izidingo zokuhlola:

Kala umkhiqizo bese urekhoda idatha yangempela, hlola uqhathanisa nezidingo zesisindo ezinikeziwe noma ulwazi lwesisindo nokubekezelela impahla yokupakisha yomkhiqizo. Uma ikhasimende linganikezi ukubekezelelana, sicela ubheke ukubekezelelana kwendawo yokuhweba (-0, +5%) ukuze unqume umphumela.

Dlula uma yonke imiphumela yokukala ingaphakathi kokubekezelela.

Uma noma yimiphi imiphumela yangempela yokukala ingaphandle kokubekezelelwa, kukukhasimende ukuthi linqume.


Isikhathi sokuthumela: Aug-09-2022

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