QUALITY MANAGEMENT OF COSMETIC PRODUCT

Anggara Martha P.

Dian Retno P.

Novia Fahrina P. S.

Siti Saharah A.
THE SCOPE
COSMETIC IS
Article intended to be poured, spinkled, or sprayed on,
introduced into or otherwise applied to the human body for
cleansing, beautifying, promoting attractiveness or altering the
appearance.
May include skin mosturizers, parfumes, lipsticks, finger nail polishes, eye
and facial make-up preparations, cleansing shampoos, permanent waves,
hair colors, deodorants, as well as any substances that is intended for use
as a component of a cosmetic product.

FOOD, DRUG, AND COSMETIC ACT – FDA (2017)

KLASIFIKASI SKIN CARE
SKIN CARE

• Shampoo, conditioner
• Tonik rambut : Hair growth, masker, serum
• Pewarna rambut : Hair color

• Eau de Parfum
• Body Mist
• Eau de toilet

• Tooth Paste
• Mouth wash

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 KARAKTERISTIK MUTU KOSMETIK

SAFETY Efikasi

Stability Usability

4
 KONTROL KUALITAS
Kontrol

5
 PROSES MANUFAKTUR KOSMETIK
DAN PENGEMBANGAN PRODUK
5 STEPS

FORMULASI SCALE UP

RISET
DESIGN UJI STABILITAS AWAL PENGEMBANGAN
6
PRODUK
 RISET PENGEMBANGAN PRODUK
Pengembangan Formula
Pengembangan bahan Uji Stabilitas
aktif baru, bahan Stabilitas skala lab, uji
pembantu baru, bentuk aplikasi (sensibility,
sediaan baru, proses mousturizing,
manufaktur smoothness),
kemudahan penggunaan
(bentuk, ukuran, bobot,
Tahap Formulasi
Input formulasi, kajian penampilan), efikasi
pustaka, permintaan (melembabkan,
pasar, percobaan lab, uji melindungi,
klinis sederhana, uji membersihkan)
keamanan formulasi, uji
7 stabilitas skala lab
 IDENTIFIKASI PERALATAN

MIXING/ SEALING,
EMULSIFICATION LABELLING,
TANK PACKAGING

DISPERSING/ FILLING
GRINDING EQUIPMENT
MILLS

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HOMOGENIZERS
 SCALE UP

LABORATORY PILOT PLANT

SIZE BATCHES
± 5 kg. ± 25-200 kg.

CLINICAL
BATCHES PRODUCTION
BATCHES
± 25 kg. > 1000 kg

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 ISO INTERNATIONAL STANDARD ORGANIZATION
ISO IS AN INDEPENDENT, NON-GOVRNMENTAL ORGANIZATION WITH A
MEMBERSHIP OF 163 NATIONAL STANDARD BODIES. ISO STANDARDS RELATED
TO COSMETIC INCLUDE OF FOLLOWING :

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 QUALITY SYSTEM FOR COSMETIC

Implementation US FDA Guidance on

of GMP 2013

GMP Compliance Encompas

and Business Ingredient &
Benefits Product Safety

Designing Quality System for Cosmetic

11 Manufacturing
DESIGN QUALITY SYSTEM FOR
COSMETIC MANUFACTURING
Phase 1
Preparation Phase 2
and Planning Design Phase
phase
Phase 3
Phase 4
Pilot phase
Implementation
phase
Phase 5
Monitoring
phse
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PREPARATION AND
PLANNING PHASE
Memperkirakan, menyiapkan, mengumpulkan informasi terkait dengan
sumber daya dan kebutuhan di dalam industri.

DESIGN PHASE
Menyiapkan sistem kerja dan dokument; mendefinisikan atau
mengembangkan proses atau sumber daya dan akhirnya, pembuatan
kebijakan, standart prosedur operasional, instruksi kerja, alur kerja,
metrik kualitas, laporan manajemen, dll.
PILOT PHASE
Melaksanakan trial (percobaan) program dan memahami kebutuhan
untuk melakukan penyesuaian atau penyesuaian, sebelum produk di
pasarkan kepada konsumen.

IMPLEMENTATION PHASE
Cosmetic GMP
MONITORING PHASE
Sistem pemantauan untuk memastikan efektivitas sistem secara
keseluruhan berjalan dengan baik. Program pemantauan ini harus
mencakup proses "tinjauan manajemen" dan pengumpulan data yang
relevan untuk mendukung sistem dan managerial yang telah berjalan
dan disusun dengan baik untuk memastikan perubahan akan efektif
dan terdokumentasi dengan baik.
 Good manufacturing practice (GMP)
Good manufacturing practice (GMP) is that part of quality management which
ensures that products are consistently produced and controlled to the quality
standards appropriate to their intended use. GMP is concerned with both production
and quality control.

Buildings and Facilities

The premises for manufacturing should be suitably located, designed, constructed
and maintained in a clean and orderly manner.

Equipment
Equitment should be a determine whether equipment and utensils used in
processing, holding, transferring and packaging are of appropriate design, size,
material and workmanship for the intended purpose to prevent corrosion,
accumulation of static material and/or adulteration with lubricants, coolants, dirt, and
sanitizing agents.
Personnel (adequate number, having knowledge, experience, skill and capabilities
relevant & should be in good health)

Documentation (history of each batch, record executed activities for maintenance,

storage, quality control, primary distribution and other specific matters related to
GMP)

Raw Materials (Identified, stored, examined, tested, inventoried, handled, and

controlled to ensure they conform to appropriate standards and specifications)

Production
Should be a determine whether written manufacturing and control SOPs have
been established (for example, formulations, processing instructions, in-process
control methods, packaging instructions, instructions for operating equipment).
Laboratory Controls (sample collection techniques, specifications, test methods,
laboratory equipment, and technician qualifications)

Quality Control (ensure that products contain the correct materials of specified
quality and quantity and are manufactured under proper conditions according
to standard operating procedures)

Internal Audit
An internal audit consists of an examination and assessment of all or part
of a quality system with the specific purpose of improving it. An internal audit
may be conducted by outside or independent specialists or a team designated
by the management for this purpose.
Complaints, recall
A person responsible for handling complaints and deciding the measures to
be taken should be designated. If this person is different from the authorised
person, the latter should be made aware of any complaint, investigation or
recal. There should be written procedures describing the action to be taken,
including the need to consider a recall, in the case of a complaint involving a
possible product defect. Complaints involving product defects should be
recorded with all the original details and investigated.
A person responsible for the execution and co-ordination of recalls should
be designated, as well as sufficient personnel, to handle all aspects of recalls
with the appropriate degree of urgency. Written procedures for recall should
be established and regularly reviewed
 KOSMETIK DI INDONESIA – KKBPOM PEDOMAN
CARA PEMBUATAN KOSMETIK YANG BAIK

KELUHAN&RECALL
PERSONALIA
BANGUNAN&FASILITAS KONTRAK
PRODUKSI&PENGUJIAN
PERALATAN

SANITASI& PENYIMPANAN
HIGIENE
AUDIT INTERNAL
PRODUKSI
DOKUMENTASI
PENGAWASAN
21
MUTU
SUMMRY OF COSMETIC REGULATION

Srikanth.T et al,
THANK YOU!
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