GMP vs. ISO 22716: What Are the Differences?

GMP vs. ISO 22716: What Are the Differences?

GMPs, or Good Manufacturing Practices Different from ISO 22716, GMPs are guidelines established by organizations to ensure that the production processes for cosmetics, food, and drinks, and pharmaceuticals are of high quality while also being repeatable.

GMP is used by the FDA to regulate several businesses and protect consumers. As a result, the rules for each industry are different.


The International Organization for Standardization (ISO) 22716

The ISO 22716 standard governs good manufacturing practices for cosmetic products.

Because of the constant monitoring of cosmetic items for dangerous substances, a set of criteria was established. End-user quality, traceability, and responsibility are all stressed throughout the guide’s production and distribution processes.

It’s not enough for companies to commit to following the rules of their business; they must also ensure that their products are safe, excellent, and of high quality.

The ISO 22716’s primary goal is to:

  • Keep the business management system in line with the European Cosmetics Regulation.
  • Open up the European market to Americans.
  • With our help, you can implement ISO 22716.
  • ISO 22716 ISO 22716 Guidelines should be implemented
  • Measures that should be taken to ensure adherence to Good Manufacturing Practices (GMPs) are described in detail in ISO 22716 standards. It addresses the following topics:


Cosmetic product production, storage, control, and shipping should be managed by a well-organized team, with clear roles and duties for each member of the team.

Premises: Proper cleaning, sanitization, and maintenance procedures are essential in order to prevent product contamination.

Reduce the danger of contamination by designing the equipment accordingly.

The corporation should look for suppliers who meet particular quality standards while purchasing raw materials.

Manufacturing: To minimize the danger of contamination, the company should provide an overview of the product’s production process, identify quality control locations, and inspect the cleanliness and safety of the equipment prior to production.

Companies must identify the forms of waste that are generated during the manufacturing of cosmetics. In order to prevent waste streams from impeding production and control, their suggestions must be implemented carefully.

The finished items must meet the quality standards defined by the company and the industry.

In order to guarantee that GMP requirements are followed, the company should conduct internal audits. The audit team should establish and verify that all of the ISO 22716 guidelines are in place.

It is important for companies to keep track of everything that goes on in their cosmetics production, storage, and shipping processes.


Main Differences between ISO 22716 and GMP

Aside from the fact that ISO 22716 is a subset of GMP, there are certain distinctions between the two. For the most part, it’s their choice of words that set them apart. There are differences in terminology between GMP and ISO directives.

Because of this, ISO standards are more flexible, whereas GMP requires enterprises to adhere. As a result, ISO 22716 covers a broader range of topics than GMP does.

Cosmetics have the ISO 22716 standard, whereas pharmaceuticals have the GMP (Good Manufacturing Practices).

Even though the requirement for medicine production security may be demonstrated, it isn’t always evident when it comes to cosmetics.

It is true that these “substances or mixtures meant for contact with the superficial areas of the human body” (extract article 2, cosmetic regulation and article L.5131-1 of the CSP) might be hazardous if their manufacturing is not at least controlled.

ISO 22716 is designed to be the industry standard for all other standards. GMP and ISO 22716 are two very different standards.


International Organization for Standardization 22716 (ISO 22716) offers Practical Recommendations

To begin with, there is a significant disparity in the number of pages in each document (the GMP has almost 300 pages, including the Annexes and the GMP for active substances, as opposed to the 22716 fewer than fifty pages.

The choice of words is one of the most significant variances between the two. While perusing ISO 22716 as an industrial pharmacist, what catches my eye the most is the use of “it is proper to” in place of “it is due to” when describing a directive.

In contrast to “it is due to”: to be required to do something, the word “it is proper to”: to be suitable for something or to be perfectly in line with something allows for more freedom.

In any case, those who choose to follow one or the other will have to adhere to it. It doesn’t matter what word you choose, because the goal is still the same.

The ISO 22716 standard covers a broader range of issues. GMP for human medications such as resources, premises, manufacturing, or complaints and recalls may be covered in ISO 22716, but they are still far less extensive.

ISO 22716 does not include any annexes, such as the one on qualification and validation. The quality risk management standard ICH Q9 is also absent.

Finally, the facts raised above illustrate that the two papers share a lot of similarities. ISO 22716 appears to be the “elder sister” of GMPs for pharmaceuticals for human use, and the latter tends to duplicate on it.

This change may not please everyone in the cosmetic industry, but what is more natural than requiring the same standards for medications and skincare products?


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