Part 1 CPKB (Cara Pembuatan Kosmetik yang Baik)

Direktorat PMPU OTSKK BPOM
17 Sept 202102:50

Summary

TLDRThis video script discusses the creation of Good Cosmetics or CPKB, which ensures products meet quality standards for their intended use. It highlights the cosmetic industry's two classifications, A and B, with A having a pharmacist in charge and B requiring a technical pharmaceutical representative. The script outlines the 12 aspects of the CPKB application, including quality management systems, personnel, facilities, sanitation, and quality control. It also emphasizes the importance of documentation, such as organizational structure, operational procedures, and labeling. The video concludes with a brief mention of hygiene and health checks for production personnel.

Takeaways

  • 😀 The video discusses the process of creating good quality cosmetics, known as CPKB (Good Cosmetics Production Practice).
  • 🛠️ CPKB involves all aspects of cosmetic production to ensure products meet quality standards and are fit for their intended use.
  • 📄 Compliance with CPKB is demonstrated through a CPKB certificate and B certificate, showing adherence to quality guidelines.
  • 🏭 The cosmetic industry is divided into Class A and Class B, with Class A having a pharmacist as the technical responsible person and Class B having a pharmaceutical technician.
  • 🚫 Class B cosmetic industry is prohibited from producing certain types of cosmetics, including those used around the eyes, mouth, and mucous membranes, and those containing acne ingredients, skin lightening agents, sunscreens, chemical peels, and hair dyes.
  • 🔬 High-technology cosmetics such as aerosols and compact powders are also part of the industry.
  • 📋 The CPKB certification application consists of 12 aspects, including quality system documentation, personnel, facilities, care place, sanitation, hygiene, production, quality control, documentation, internal audit, storage, contract production, and testing and complaint handling.
  • 🧼 Hygiene and sanitation are key components of the CPKB documentation, covering personal hygiene, health checks for production personnel, cleanliness of rooms, and sanitation of equipment.
  • 📝 Documentation is a crucial part of the application, including organizational structure specifications, operational programs, procedures, and operational protocols (POP), as well as records.
  • 🏷️ Labeling is also an important aspect of CPKB, ensuring proper identification and information about the cosmetic products.
  • 👋 The video concludes with an invitation to the next explanation, indicating a series of educational content on the topic.

Q & A

  • What is the main topic of the video?

    -The main topic of the video is the discussion of good cosmetic manufacturing practices (GMP) and the certification process for cosmetic products in Indonesia.

  • What does 'CPKB' stand for in the context of the video?

    -In the context of the video, 'CPKB' stands for 'Ciri-ciri Pabrik Kosmetik Baik,' which translates to 'Good Cosmetic Factory Characteristics' in English.

  • What are the two types of cosmetic industries mentioned in the video?

    -The two types of cosmetic industries mentioned are Group A, which has a pharmacist as the technical responsible person, and Group B, which has a pharmaceutical technician as the technical responsible person.

  • What are the products that are prohibited to be produced by Group B cosmetic industry?

    -The products prohibited for production by the Group B cosmetic industry include cosmetics used around the eyes, mouth, and mucous membranes, anti-acne products, skin bleaching agents, sunscreens, chemical peeling, and hair dyes.

  • What does the certification process for CPKB involve?

    -The certification process for CPKB involves demonstrating compliance with various aspects of good manufacturing practices, including obtaining a PKB certificate and fulfilling the 12 aspects of the CPKB standard.

  • What are the 12 aspects of the CPKB standard mentioned in the video?

    -The 12 aspects of the CPKB standard include quality management system, personnel, building and facilities, care place, sanitation and hygiene, production, quality control, documentation, internal audit, storage, production contract, and complaint handling and product recall.

  • What is the significance of having a quality management system in the context of CPKB?

    -A quality management system is significant in the context of CPKB as it ensures that the manufacturing processes are controlled and monitored to meet the quality requirements of the cosmetic products.

  • What does 'hygiene and sanitation' in the CPKB standard encompass?

    -In the CPKB standard, 'hygiene and sanitation' includes personal hygiene, health checks for production personnel, cleanliness and sanitation of the rooms, and cleanliness and sanitation of the equipment.

  • What is the role of documentation in the CPKB certification process?

    -Documentation plays a crucial role in the CPKB certification process as it includes specifications, organizational structure, standard operating procedures, and records that demonstrate compliance with the quality standards.

  • What is the purpose of the internal audit in the CPKB standard?

    -The purpose of the internal audit in the CPKB standard is to regularly assess and ensure that the company's processes and systems are in line with the quality management system and are effectively implementing the CPKB requirements.

  • How does the video conclude?

    -The video concludes with a sign-off, indicating that the explanation of CPKB is complete and the audience can look forward to the next explanation, followed by applause and music.

Outlines

00:00

💄 Introduction to Good Cosmetic Production Practices (GCMP)

This paragraph introduces the topic of the video, which is about the Good Cosmetic Production Practices (GCMP). It explains that GCMP encompasses all activities aimed at ensuring that the produced cosmetics meet quality requirements for their intended use. The paragraph also mentions the importance of obtaining a GCMP certificate and B certificate to prove compliance with these practices. It distinguishes between two types of cosmetic industries: Class A, which has a pharmacist as the technical responsible person, and Class B, which has a pharmaceutical technician. The paragraph also lists products that are prohibited for Class B industries to produce, such as cosmetics used around the eyes, mouth, and mucous membranes, as well as those containing anti-acne ingredients, skin bleaching agents, sun protection, chemical peeling, and hair dyeing products. Additionally, it touches on high-technology cosmetics like aerosols and compact powders. The paragraph concludes with an overview of the 12 aspects of the GCMP certification application, including quality management systems, personnel, facilities, sanitation, production, quality control, documentation, internal audits, storage, contract manufacturing, testing, and complaint handling.

Mindmap

Keywords

💡Cosmetic Production

Cosmetic production refers to the process of creating cosmetic products, which includes formulation, manufacturing, and packaging. In the video script, it is discussed as an activity aimed at ensuring the quality of the products. The script mentions the 'good cosmetic production practice' or 'CPKB', which is a set of guidelines to ensure the quality of the produced cosmetics.

💡CPKB

CPKB, or 'Good Cosmetic Production Practice', is a comprehensive set of activities in cosmetic production that aims to ensure the quality of the products according to their intended use. The script highlights that compliance with CPKB is proven by a 'PKB certificate' and 'B certificate', which are part of the cosmetic industry's quality assurance.

💡Certificate PKB

A 'Certificate PKB' is a document that certifies compliance with the Good Cosmetic Production Practice (CPKB). It is mentioned in the script as a proof of adherence to the required standards in the cosmetic industry, ensuring the quality and safety of the products.

💡Cosmetic Industry

The cosmetic industry encompasses businesses involved in the production and sale of cosmetic products. The script differentiates between 'Class A' and 'Class B' cosmetic industries, with Class A having a pharmacist as the technical responsible person and Class B having a pharmaceutical technician in the same role.

💡Class A Cosmetic Industry

Class A Cosmetic Industry refers to a segment of the cosmetic industry where a pharmacist is responsible for the technical aspects of production. This indicates a higher level of professional oversight in the production process, as mentioned in the script.

💡Class B Cosmetic Industry

Class B Cosmetic Industry is another segment of the cosmetic industry where a pharmaceutical technician is the technical responsible person. This class has certain restrictions, such as the prohibition of producing certain types of cosmetics, as highlighted in the script.

💡Quality Management System

A quality management system is a set of policies, procedures, and guidelines that help organizations ensure the quality of their products or services. In the script, it is one of the 12 aspects of the CPKB application for a certificate, emphasizing the importance of a structured approach to quality in cosmetic production.

💡Hygiene and Sanitation

Hygiene and sanitation are critical aspects of cosmetic production, ensuring the cleanliness of personnel, facilities, and equipment to prevent contamination. The script mentions 'hygiene and sanitation' as a key document for the CPKB application, including personal hygiene, health checks, and cleanliness of production areas and equipment.

💡Documentation

Documentation in the context of CPKB refers to the collection of records and written procedures that support the quality management system. The script specifies that documentation includes organizational structure specifications, standard operating procedures, and operational protocols, which are essential for maintaining quality standards.

💡Labeling

Labeling is the practice of providing information on a cosmetic product's packaging, which includes ingredients, usage instructions, and warnings. In the script, labeling is mentioned as the last component of documentation for the CPKB application, indicating its importance in providing consumers with necessary product information.

💡Complaint Handling

Complaint handling is the process of receiving, investigating, and resolving consumer complaints about a product. The script includes 'complaint handling' and 'product recall' as part of the CPKB requirements, showing the industry's commitment to addressing consumer concerns and maintaining product safety.

Highlights

This video discusses the creation of good cosmetic production (CPKB).

CPKB involves all activities to ensure cosmetic products meet quality requirements.

CPKB is proven by a PKB certificate and a compliance certificate.

Cosmetic industry is divided into Class A and Class B, with different technical responsibilities.

Class A cosmetics industry has a pharmacist as the technical responsible person.

Class B cosmetics industry has a pharmaceutical technician as the technical responsible person.

Products prohibited for Class B production include cosmetics for eyes, mouth, and mucous membranes, and those containing acne ingredients, sunscreens, chemical peels, and hair dyes.

High-tech cosmetics include aerosols and compact powders.

CPKB certificate application consists of 12 aspects including quality system documentation.

Quality system documentation includes personal hygiene, health checks, and facility cleanliness.

Documentation also covers organizational structure, operational procedures, and standard operating procedures.

Labeling is an essential part of the documentation for CPKB compliance.

The video provides a comprehensive explanation of CPKB, guiding viewers through the certification process.

The video concludes with a summary and an invitation to the next explanation.

Applause and music are used to signify the end of the video.

Transcripts

play00:00

hai hai

play00:00

[Musik]

play00:02

halo

play00:03

halo di video kali ini kita akan

play00:06

membahas tentang cara pembuatan kosmetik

play00:08

yang baik atau cpkb cara pembuatan

play00:11

kosmetik yang baik atau cpkb adalah

play00:13

seluruh aspek kegiatan pembuatan

play00:15

kosmetika yang bertujuan untuk menjamin

play00:18

agar produk yang dihasilkan memenuhi

play00:20

persyaratan mutu sesuai dengan tujuan

play00:22

penggunaannya

play00:25

penerapan pedoman cpkb dibuktikan dengan

play00:28

a certificate PKB dan b sertifikat

play00:32

pemenuhan aspek atau sport cpkb

play00:35

industri kosmetik terdiri dari industri

play00:38

kosmetik golongan A dan golongan b

play00:40

industri kosmetik golongan A adalah

play00:43

industri kosmetik yang memiliki apoteker

play00:46

sebagai penanggung jawab teknis

play00:47

sedangkan industri kosmetik golongan B

play00:50

adalah industri kosmetik yang memiliki

play00:52

tenaga teknis kefarmasian sebagai

play00:55

penanggung jawab teknis produk yang

play00:57

dilarang diproduksi oleh industri

play00:58

kosmetik golongan B adalah 10

play01:02

tiga untuk baik2 kosmetika yang

play01:05

digunakan di sekitar mata rongga mulut

play01:08

dan atau membran mukosa tiga kosmetik

play01:11

yang mengandung bahan anti jerawat

play01:13

pencerah kulit tabir surya Chemical

play01:16

Peeling dan pewarna rambut dan yang

play01:19

keempat kosmetika yang menggunakan

play01:21

teknologi tinggi seperti aerosol dan

play01:24

serbuk kompak aspek pengajuan sertifikat

play01:27

cpkb terdiri dari 12 aspek dokumen

play01:30

sistem mutu yaitu satu sistem manajemen

play01:33

mutu dua personalia tiga bangunan dan

play01:38

fasilitas Tempat perawatan 5 sanitasi

play01:43

dan hygiene 6 produksi 7 pengawasan mutu

play01:48

8 dokumentasi 9 out internal 10

play01:54

penyimpanan 11 kontrak produksi dan

play01:57

pengujian dan 12 penanganan keluhan dan

play02:00

penarikan produk

play02:01

[Musik]

play02:03

Hai dokumen sistem mutu untuk pengajuan

play02:05

sertifikat pemenuhan aspek atau spa cpkb

play02:08

adalah satu hygiene dan sanitasi yang

play02:11

terdiri dari hygiene perorangan

play02:14

pemeriksaan kesehatan personil produksi

play02:17

kebersihan dan sanitasi ruangan dan

play02:20

kebersihan dan sanitasi peralatan dan

play02:22

yang kedua dokumentasi yang terdiri dari

play02:26

spesifikasi struktur organisasi program

play02:29

dan prosedur operasional baku atau pop

play02:32

catatan dan yang terakhir label

play02:36

hai hai

play02:38

Hai sekian penjelasan tentang cpkb

play02:41

sampai jumpa di penjelasan berikutnya

play02:44

[Musik]

play02:46

[Tepuk tangan]

play02:47

[Musik]

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الوسوم ذات الصلة
Cosmetic ProductionCPKB CertificationQuality StandardsSafety MeasuresTechnical PersonnelPharmaceutical IndustryHygiene ProtocolQuality ManagementProduct TestingRegulatory Compliance
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