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GMP Cosmetics Certification
What is GMP Cosmetics Certificate?
Current Good manufacturing practices (cGMP) are those conforming to the
guidelines recommended by relevant agencies. Those agencies control the
authorization and licensing of the manufacture and sale
of food and beverages, cosmetics, pharmaceutical products, dietary
supplements, and medical devices. These guidelines provide minimum requirements
that a manufacturer must meet to assure that their products are consistently high in
quality, from batch to batch, for their intended use. The rules that govern each industry
may differ significantly; however, the main purpose of GMP is always to prevent
harm from occurring to the end user. Additional tenets include ensuring the end
product is free from contamination, that it is consistent in its manufacture, that its
manufacture has been well documented, that personnel are well trained, and that the
product has been checked for quality more than just at the end phase. GMP is typically
ensured through the effective use of a quality management system (QMS).
Good manufacturing practices, along with good agricultural practices, good laboratory
practices and good clinical practices, are overseen by regulatory agencies in the United
Kingdom, United States, Canada, Europe, China, India and other countries.
Cosmetics are constituted mixtures of chemical compounds derived from
either natural sources, or synthetically created ones. Cosmetics have various
purposes. Those designed for personal care and skin care can be used
to cleanse or protect the body or skin. Cosmetics designed to enhance or alter
one's appearance (makeup) can be used to conceal blemishes, enhance one's
natural features (such as the eyebrows and eyelashes), add color to a person's
face, or change the appearance of the face entirely to resemble a different person,
creature or object. Cosmetics can also be designed to add fragrance to the body.
Deming Certification & Rating Pvt. Ltd.
Email: - info@demingcert.com
Contact: - 02502341257/9322728183
Website: - www.demingcert.com
No. 108, Mehta Chambers, Station Road, Novghar, Behind Tungareswar Sweet,
Vasai West, Thane District, Mumbai- 401202, Maharashtra, India
Definition and etymology
A bust of the Egyptian queen Nefertiti showing the use of eye liner made of kohl
An 1889 Henri de Toulouse-Lautrec painting of a woman applying facial cosmetics
Kissproof brand face powder from 1926, from the permanent
collection of the Museo del Objeto del Objeto in Mexico City
The word cosmetics derives from the Greek ÎșÎżÏƒÎŒÎ·Ï„ÎčÎșᜎ τέχΜη ("kosmetikē tekhnē"), meaning "technique
of dress and ornament", from ÎșÎżÏƒÎŒÎ·Ï„ÎčÎșός ("kosmētikos"), "skilled in ordering or arranging" and that
from ÎșÏŒÏƒÎŒÎżÏ‚ ("kosmos"), meaning "order" and "ornament". Cosmetics are constituted from a mixture
of chemical compounds derived from either natural sources, or synthetically created ones.
Legal definition:
Though the legal definition of cosmetics in most countries is broader, in some Western countries,
cosmetics are commonly taken to mean only makeup products, such as lipstick, mascara, eye
shadow, foundation, blush, highlighter, bronzer, and several other product types.
In the United States, the Food and Drug Administration (FDA), which regulates cosmetics, defines
cosmetics as products "intended to be applied to the human body for cleansing, beautifying, promoting
attractiveness, or altering the appearance without affecting the body's structure or functions". This broad
definition includes any material intended for use as an ingredient of a cosmetic product, with the FDA
specifically excluding pure soap from this category.
. Use
Cosmetics designed for skin care can be used to cleanse, exfoliate and protect the skin, as well as
replenishing it, through the use of cleansers, toners, serums, moisturizers, and balms. Cosmetics designed
for more general personal care, such as shampoo and body wash, can be used to cleanse the body.
Cosmetics designed to enhance one's appearance (makeup) can be used to conceal blemishes, enhance
one's natural features (such as the eyebrows and eyelashes), add color to a person's face and—in the case
of more extreme forms of makeup used for performances, fashion shows and people in costume—can be
used to change the appearance of the face entirely to resemble a different person, creature or object.
Techniques for changing appearance include contouring, which aims to give shape to an area of the face.
Cosmetics can also be designed to add fragrance to the body.
Enforcement
Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP
inspections are performed in Canada by the Health Products and Food Branch Inspectorate; in the United
Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA); in the Republic of
Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS); in Australia by the Therapeutic
Goods Administration (TGA); in Bangladesh by the Directorate General of Drug Administration
(DGDA); in South Africa by the Medicines Control Council (MCC); in Brazil by the National Health
Surveillance Agency (ANVISA); in India by state Food and Drugs Administrations (FDA), reporting to
the Central Drugs Standard Control Organization; in Pakistan by the Drug Regulatory Authority of
Pakistan; in Nigeria by NAFDAC; and by similar national organizations worldwide. Each of
the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely
and correctly. Additionally, many countries perform pre-approval inspections (PAI) for GMP compliance
prior to the approval of a new drug for marketing.
CGMP inspections
Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations)
are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic
inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and
Cosmetic Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts
have held that any time the firm is open for business is a reasonable time for an inspection.
Other good practices
Other good-practice systems, along the same lines as GMP, exist:
‱ Good agricultural practice (GAP), for farming and ranching
‱ Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in
humans
‱ Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal
products for human use.
‱ Good laboratory practice (GLP), for laboratories conducting non-clinical
studies (toxicology and pharmacology studies in animals)
‱ Good pharmacovigilance practice (GVP), for the safety of produced drugs
‱ Good regulatory practice (GRP), for the management of regulatory commitments, procedures and
documentation
Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of
which follow similar philosophies. Other examples include good guidance practices, and good tissue
practices.

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GMP Cosmetics Certification.pdf

  • 1. GMP Cosmetics Certification What is GMP Cosmetics Certificate? Current Good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS). Good manufacturing practices, along with good agricultural practices, good laboratory practices and good clinical practices, are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries. Cosmetics are constituted mixtures of chemical compounds derived from either natural sources, or synthetically created ones. Cosmetics have various purposes. Those designed for personal care and skin care can be used to cleanse or protect the body or skin. Cosmetics designed to enhance or alter one's appearance (makeup) can be used to conceal blemishes, enhance one's natural features (such as the eyebrows and eyelashes), add color to a person's face, or change the appearance of the face entirely to resemble a different person, creature or object. Cosmetics can also be designed to add fragrance to the body. Deming Certification & Rating Pvt. Ltd. Email: - info@demingcert.com Contact: - 02502341257/9322728183 Website: - www.demingcert.com No. 108, Mehta Chambers, Station Road, Novghar, Behind Tungareswar Sweet, Vasai West, Thane District, Mumbai- 401202, Maharashtra, India
  • 2. Definition and etymology A bust of the Egyptian queen Nefertiti showing the use of eye liner made of kohl An 1889 Henri de Toulouse-Lautrec painting of a woman applying facial cosmetics Kissproof brand face powder from 1926, from the permanent collection of the Museo del Objeto del Objeto in Mexico City The word cosmetics derives from the Greek ÎșÎżÏƒÎŒÎ·Ï„ÎčÎșᜎ τέχΜη ("kosmetikē tekhnē"), meaning "technique of dress and ornament", from ÎșÎżÏƒÎŒÎ·Ï„ÎčÎșός ("kosmētikos"), "skilled in ordering or arranging" and that from ÎșÏŒÏƒÎŒÎżÏ‚ ("kosmos"), meaning "order" and "ornament". Cosmetics are constituted from a mixture of chemical compounds derived from either natural sources, or synthetically created ones.
  • 3. Legal definition: Though the legal definition of cosmetics in most countries is broader, in some Western countries, cosmetics are commonly taken to mean only makeup products, such as lipstick, mascara, eye shadow, foundation, blush, highlighter, bronzer, and several other product types. In the United States, the Food and Drug Administration (FDA), which regulates cosmetics, defines cosmetics as products "intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions". This broad definition includes any material intended for use as an ingredient of a cosmetic product, with the FDA specifically excluding pure soap from this category. . Use Cosmetics designed for skin care can be used to cleanse, exfoliate and protect the skin, as well as replenishing it, through the use of cleansers, toners, serums, moisturizers, and balms. Cosmetics designed for more general personal care, such as shampoo and body wash, can be used to cleanse the body. Cosmetics designed to enhance one's appearance (makeup) can be used to conceal blemishes, enhance one's natural features (such as the eyebrows and eyelashes), add color to a person's face and—in the case of more extreme forms of makeup used for performances, fashion shows and people in costume—can be used to change the appearance of the face entirely to resemble a different person, creature or object. Techniques for changing appearance include contouring, which aims to give shape to an area of the face. Cosmetics can also be designed to add fragrance to the body. Enforcement Within the European Union GMP inspections are performed by National Regulatory Agencies. GMP inspections are performed in Canada by the Health Products and Food Branch Inspectorate; in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA); in the Republic of Korea (South Korea) by the Ministry of Food and Drug Safety (MFDS); in Australia by the Therapeutic Goods Administration (TGA); in Bangladesh by the Directorate General of Drug Administration (DGDA); in South Africa by the Medicines Control Council (MCC); in Brazil by the National Health Surveillance Agency (ANVISA); in India by state Food and Drugs Administrations (FDA), reporting to the Central Drugs Standard Control Organization; in Pakistan by the Drug Regulatory Authority of Pakistan; in Nigeria by NAFDAC; and by similar national organizations worldwide. Each of the inspectorates carries out routine GMP inspections to ensure that drug products are produced safely and correctly. Additionally, many countries perform pre-approval inspections (PAI) for GMP compliance prior to the approval of a new drug for marketing. CGMP inspections Regulatory agencies (including the FDA in the U.S. and regulatory agencies in many European nations) are authorized to conduct unannounced inspections, though some are scheduled. FDA routine domestic inspections are usually unannounced, but must be conducted according to 704(a) of the Food, Drug and Cosmetic Act (21 USCS § 374), which requires that they are performed at a "reasonable time". Courts have held that any time the firm is open for business is a reasonable time for an inspection. Other good practices Other good-practice systems, along the same lines as GMP, exist:
  • 4. ‱ Good agricultural practice (GAP), for farming and ranching ‱ Good clinical practice (GCP), for hospitals and clinicians conducting clinical studies on new drugs in humans ‱ Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. ‱ Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals) ‱ Good pharmacovigilance practice (GVP), for the safety of produced drugs ‱ Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation Collectively, these and other good-practice requirements are referred to as "GxP" requirements, all of which follow similar philosophies. Other examples include good guidance practices, and good tissue practices.