Weekly report Regulatory Nadia

No Detail Name of the product

1 Review documents from principle

2 Input product to BPOM/ MOH systems

Heliocare 360 fluide cream

Heliocare 360 gel cream

SESDERMA SENSYSES CLEANSER SEBUM OILY

Pendaftaran Sub Account Baru (PHYTOMER)

PHYTOMER CITADINE CREME SORBET

3 Follow up product BPOM

PHYTOMER CITADINE PEELING MINUTE
ULTRA NETTOYANT
PHYTOMER HYDRASEA thirst-relief
Rehydrating Mask

Heliocare Oral PRW 120 & 240

Follow up Pendaftaran Sub Account Baru

(KIDSKIN)

SESDDERMA

Principle
SESDERMA C-VIT LIPOSOMAL MIST
LUMINOSITY MIST
MEDIDERMA 3-RETISES CT YELLOW PEEL.
CHEMICAL PEEL

4 Variation new address Prepare new SOP

5 RENEWAL PRODUCT ULTRA V Idebenone Cream

6 Visit gudang atas izin pak edy all product

7 TRANSLATE PRODUCT BIOLOGIQUE RECHERCHE

8 Webinar w/ Indonesia Halal Training Challenge on HALAL Certification of Cosmetics

eport Regulatory Nadia

comments

waiting approved new LoA w/ BPOM

waiting approved new LoA w/ BPOM

waiting approved new GMP w/ BPOM

waiting approved

submited deficiency data to BPOM. evaluation is in stage 1

Status in BPOM/Principle
waiting evaluation BPOM

waiting evaluation BPOM

follow up & discussion additional documents with BPOM (mba dewi and mba nia) we
should provide data toksisitas dari produk jadi, provide protokol uji toksisitas dengan
metode yang disetujui oleh BPOM , data uji klinik produk jadi, wajib menginformasikan
produk beredar di negara mana saja (minimal 5 negara) dan memberikan klaim seperti
apa saja di berbagai negara tersebut

waiting the additional document from principle

followup again by email notifkos bpom, and maybe to long evaluation process because
the new GMP not legalized by indonesian embassy

Status in BPOM/Principle

waiting for additional documents from principle (sofia)

waiting for additional documents from principle (sofia)

make work agreement documents

prepare photos of all product brands
make a letter ready for audit
make a letter for recommendation
make a statement letter that is free from crime

on process evaluation by BPOM

make sure that all products are labeled

see products that are not labeled
conveying information that the warehouse must store sampel pertinggal of all types of
products in the glass cabinet and must be locked

see products that are not labeled

check untranslated products
check the stock card, input it to move in the system to make it more integrated

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Halal means permissible or lawful. Thoyyib means quality, wholesome and not harmful to
health. LPPOM MUI mengeluarkan Product PARADIGMA yang menghasilkan Worthy, safe
and halal. And costomer statisfacation

Haram material mentioning in Qur'an = Pork, Carrion, Blood, Animal slaughtered by not
mentioning the name of Allh (God), khamr (alcoholic beverages) Wild animal (Carnivour).
Animals with sharp teeth and claws, amphibia (animal who live in both land and water)

TYPE of Najis/Najassah = lurine from baby boy who only breastfeed (light najis). Urine,
feces, carrion, khamr, blood, etc (Medium Najis). Pig and its derivatives and saliva from
dog(heavy najis).

object that is exposed to najis material is called MUTANNAJIS. Every najis and mutannajis
material is haram to be use (internal/external use). Not all haram hair and horn of halal
animal but not slaughtered in Islamic way is haram for internal use but not najis for
external use. mutannajis material/facility can be washed by rmoving the najis according to
islamic purification requirements.
depends on the application, cosmetics can be used as : 1. internal uses : can be
eaten/swallowed such as lipstick, lipbalm. 2.External use : applied to some part of human
body on a certain time and maybe affect to the ablution status. Ex : hair coloring,
waterproof decorative cosmetics, etc

fatwa no 26(2013) using cosmetics is allowed as long as the cosmetics are not made from
haram/najis materials, the material are safe. Cosmetics product that contains GMO which
uses gene from pork or human are haram. Cosmetis product which ue animal (cattle)
derived materials that are not clear in slaughtering process. cosmetics product which uses
microbialmaterial with unclear media information whether from pork/derivatives or not.
Fatwa MUI on relevant materials of cosmetics : all animal from the sea, shellac : resin
obtained from laccifer lacca kerr secreiton. GMO : as long as the gene are not from pig or
human. Carmine/cochineal : all additives and processing aids used must be halal.
materials from bees : honey royal jelly, bee polen, propolis, bees wax, apitoxin.

Requirements of Material for External Products applied externally, not to be consumed. Ex

: face cream, body lotion, swimming block, the following materials can be used for
external product : etanol that does not come from khamr, placenta taken from the birth
process of halal animals, fur, hair and horns of halal animal carrion, including those are
not slaughtered according to islamic law. snail secretion (mucin) silk worm cocoons,
goldparticle for men : for thepurpose that in linewith syarriah law, there is benefit and not
dangerous.