The Good Manufacturing Practices Guide is known as a set of standards that allows organizations to have greater control over their processes through process standardization. It also enjoys benefits such as avoiding the costs of poor quality that are typically associated with reprocessing or product destruction due to errors that affect product quality.
Due to the growing need for organizations to guarantee the quality of their products, Good Manufacturing Practices (GMP) were created as a solution to this requirement.
Good Manufacturing Practices 2025
According to ICONTEC, the acronym GMP stands for Good Manufacturing Practices in industry.
Good manufacturing practices are intended to control:
- Plant facilities;
- Equipment and utensils used;
- Personnel hygiene requirements during manufacturing;
- Raw materials and inputs used;
- Production operations (manufacturing, packaging, labeling, and packing);
- Storage, distribution, transportation, and marketing; and
- Quality assurance and control.
“Good manufacturing practices are the basic principles and general hygiene practices in the handling, preparation, processing, packaging, storage, transportation, and distribution” of all products intended for human consumption.
To ensure product safety and security, guidelines and requirements proposed in various national and international regulations must be taken into account if international expansion is desired.
GMP in the United States
Why was the Good Manufacturing Practices Guide created?
Good Manufacturing Practices (GMP) were born in response to fatal incidents due to a lack of safety, purity, and efficacy in food and medicines. This is how the U.S. Food and Drug Administration (FDA) was founded in 1906.
It was in 1962 when great concern arose from the news of the effects of Thalidomide, a drug developed for sedation and nausea relief in the early months of pregnancy. After ingestion, it caused thousands of birth defects. This event inspired the emergence of the Kefauver-Harris Amendment, thus creating the first Good Manufacturing Practices guide.
This guide established the obligation for drug manufacturers to provide products that had been approved for safety and efficacy before marketing.
To define the quality of a product, all factors that directly or indirectly affect the production of a product of acceptable, safe, and effective quality must be taken into account.
These aforementioned factors include:
Product research, design, and development, acquisition of raw materials and supplies, dispensing, manufacturing, packaging, packaging, storage, and distribution.
Therefore, it can be concluded that final product inspection and evaluation is insufficient to guarantee a high-quality product. In other words, it applies to the entire manufacturing process of a cosmetic product.
Examples of Regulations
Over the past few years, various regulations have been developed to ensure that products are manufactured under the appropriate safety and health conditions, thereby maintaining product quality and safety and reducing production-related risks.
According to Decree 219 of 1998,10 this was issued by the Ministry of Health and published on January 30, 1998, establishing “the sanitary requirements for quality control and surveillance of cosmetic products during the manufacturing, packaging, import, export, and marketing processes.”
According to Decree 612 of 2000,11 this was issued by the Ministry of Health and published on April 5, 2000, establishing the requirements for issuing sanitary registrations for products within the line of cosmetics, foods, and other similar products supervised by INVIMA. With the exception of medicines, pharmaceutical preparations, and alcoholic beverages, as they are subject to special regulations.
ISO STANDARDS
ISO 22716: The New Good Manufacturing Practices Guide
ISO 22716 is the new Good Manufacturing Practices (GMP) guide for the cosmetics industry and describes the basic principles of applying GMP in a facility that produces finished cosmetic products.
ISO 22716:2008 is the European standard, designed to provide companies with guidelines for the manufacture, control, storage, and distribution of cosmetic products in a way that guarantees their quality and safety.
According to the ISO 22176:200812 standard, the types of cosmetic products within the scope of this regulation would be: creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.), facial masks, tinted bases (liquid, pastes, powders), makeup powders, after-bath powders, hygienic powders, perfumes, deodorants and hair care products, among others.
How can I implement Good Manufacturing Practices in Cosmetics?
How can I implement Good Manufacturing Practices in Cosmetics?
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