The International Organization for Standardization (ISO) 22716 is a set of comprehensive guidelines for GMP for cosmetics and personal care sector introduced in 2007.
Cosmetics refer to the goods or materials intended to enhance, cleanse, or alter a consumer's face or body through makeup, oral care to products such as creams, deodorants, hair products, and fragrances.
The ISO is an internationally recognized non-governmental body that sets many standards across a wide range of industries. In 2007, the International Cooperation on Cosmetic Regulations (ICCR), formed by the United States (US), Canada, European Union (EU), and Japan, determined this standard would be used when recommending or publishing cosmetic GMP guidelines for each country[1].
This makes the ISO 22716 good manufacturing practice cosmetics guidelines the criteria of cosmetics GMP when it comes to international standards.
In 2013, the Food and Drug Administration (FDA) in the US published its updated GMP guidelines, considering the recommendations stated in ISO 22716.
GMP is also known as cGMP, referring to current Good Manufacturing Practices, which emphasize the requirements for companies to adopt tools and technologies that are consistent with the standards presently set[2].
Good Manufacturing Practice Cosmetics Standard
This ISO standard is the benchmark in cosmetics GMP. ISO 22716 certification helps businesses identify and mitigate the risks associated with production that can impact product safety and quality.
As its name implies, GMP allows organizations to demonstrate their commitment to safeguarding the quality and safety of their finished cosmetics products.
It is the first step in cosmetics compliance, providing a comprehensive approach for quality management to make sure the way a product is designed, formulated, manufactured, packaged, stored, and shipped is achieved safely, hygienically, and responsibly.
The success of all cosmetics businesses relies heavily on its capacity to produce effective, safe, high quality, and reputable cosmetic products.
Understanding the fundamentals of GMP is extremely beneficial, addressing one of the most important aspects of cosmetics manufacturing: To protect consumers by enhancing cosmetic product safety across all elements of the supply chain.
Global GMP Regulations
The Cosmetics Regulation 1223/2009 requires that all cosmetic products sold into the EU market comply with good manufacturing practice cosmetics as set out in the ISO 22716 standard.
It's widely accepted that cosmetic products sold in the EU have been manufactured in compliance with GMP.
Following GMP guidelines can extend beyond legal compliance and benefits companies through increased sales and driving brand loyalty by placing an emphasis on the quality, safety, and efficacy of the product.
Compliance with good manufacturing practices for cosmetics is mandatory in the EU, however in the US and Canada, various regulations that govern the sale of cosmetic products.
Implementing GMP standards is not mandatory but highly encouraged by the FDA and Health Canada, respectively[3]
Current and upcoming cosmetics safety guidelines in the U.S. and Canada include:
- The FDA-enforced Federal Food, Drug and Cosmetic Act (Section 301) - Forbids the sale of cosmetic products that are "adulterated" or "mis-branded"
- The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) - U.S. legislation that will soon require cosmetics marketed in the U.S. to be manufactured in accordance with GMPs, which will be determined and enforced by FDA
- In Canada, the Food and Drugs Act (Sections 16 and 18) - States that cosmetics sold must be produced and stored in clean, hygienic environments
Even in the absence of a requirement to adhere to GMPs, processes related to GMPs are integral to quality assurance and guidelines help companies manufacture products consistently high in quality from batch to batch.
Implementing industry standard GMP according to ISO 22716:2007 requires considering the following GMP guidelines[4]:
GMP for Cosmetics - Personnel
Cosmetics GMP highlights the importance of ensuring that employees of the cosmetics company are all adequately trained, experienced, and qualified to correctly produce, store and control products to the company’s specifications, contributing to safety and quality rather than compromising it.
They should also have the necessary support from the company in the form of full GMP training (personnel hygiene and health), supervision, safety equipment, personal protective equipment (PPE), education, resources, etc. to perform their job and tasks efficiently with good hygiene and cleanliness.
Premises
The premises of a cosmetics manufacturer should always meet the GMP specifications, providing a safe, hygienic environment that minimizes the risk of contamination.
The amenities should be organized to allow for adequate division of storage, production, quality control, washing, sanitization, toilet facilities, and any further supporting facilities, and ensure that cleaning and maintenance protocols are in place.
This protects the cosmetics products that are being manufactured, minimizes any risks of mixing up products, ingredients, and packaging materials, and ensures cleanliness is kept to a high standard as part of the GMP process.
Equipment
All equipment used should be suitable for its purpose and should be adequately cleaned, sanitized, and maintained to prevent air contamination, such as dust or moisture.
A core part of a company’s GMP procedure is that the equipment used for manufacture of the cosmetic product is only used for this purpose. The equipment should also be stored properly and calibrated periodically if needed.
It is also essential to ensure the equipment isn’t made of any material that could interact with the ingredients, products, or cleaning agents.
If broken or no longer suitable for use, equipment should be fixed, replaced, or disposed of adequately and safely.
Raw Materials and Packaging Materials
All ingredients, raw materials, and packaging materials should meet an acceptance criterion to ensure the quality of the finished product.
All raw materials should be well organized and correctly labeled along with packaging materials to prevent mix-up with any products.
These labels must contain batch/lot information so that they can be traced at any point in the manufacturing process. Additionally, regular inventories of stock should be carried out and any discrepancies investigated.
Production
Measures should be taken every step of the way to ensure that the finished product meets its specifications. Appropriate documentation and records should be created to capture all aspects of the production process.
The guideline recommends establishing standard operating procedures (SOPs) for all processes. An SOP is simply a clearly written instructional document that clarifies in detail how a specific production activity is conducted.
This includes GMP for cosmetics guidelines, the new product formulation of the cosmetic product in percentages, and weight/volume.
Also, a list of all the raw materials used including their batch numbers and quantities, and the method of manufacture.
Finished Products
Finished products must meet the quality standards established by the company and reflect GMP.
Before a finished product is placed on the market, it is necessary to verify the compliance with defined quality criteria. Strict rules of storage must be adhered to for finished products, ensuring appropriate conditions.
Finished product storage containers should list the product's:
- Name
- Batch number
- Relevant storage conditions
- Quantity
Undertaking regular inventory checks ensures that products are stored adequately. Their quality must be maintained during storage operations, shipping, and product returns.
GMP for Cosmetics - Quality Control
Quality refers to the stability of a cosmetic product, its preservation, and its overall function. Many of the required tests check that the quality of a product remains to a high standard.
Any products containing water are at risk of contamination of microbial growth and will require sampled quality checks to ensure a product remains stable and passes challenge tests.
For sampling and testing purposes, samples must be identifiable by their:
- Name
- Concentration
- Expiration date
- Opening date
- Storage conditions
- Name of the person who prepared them
The samples should be taken in sufficient sizes so that any local regulatory bodies could undertake analysis on them if required.
Complaints and Recalls
In conjunction with GMP for cosmetics ISO 22716, any complaints or adverse events reported about a cosmetic product must be reviewed, investigated, and followed-up on.
All complaints should be centrally recorded using a systematic complaint logging and review process, investigating complaints should include the steps to prevent a product defect from reoccurring, recognizing potential issues with safety or quality.
If a severe or high-risk safety or quality issue is suspected, a company must be capable of implementing a product recall quickly and efficiently.
Again, relevant documentation should be created to ensure there is a systematic plan of action to inform the appropriate authorities of the recall, which could impact consumer safety.
GMP for Cosmetics Audit and Documentation
To ensure the implementation and enforcement of GMP for good manufacturing practice cosmetics, it is essential to conduct an internal audit, to evaluate the overall performance of a quality management system.
It should be able to identify the system's strengths and weaknesses, as well as advise a plan of action to overcome failings in GMP good manufacturing practice cosmetics.
A good internal audit should be unbiased and undertaken by a qualified person, where any problems found during audits must be corrected, verifying that all guidelines outlined in the ISO 22716 standard are correctly implemented[5].
GMP for Cosmetics - Footnotes:
[1] ISO 22716:2007 - Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
[2] Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
[3] How FDA Approves Drugs and Regulates Their Safety and Effectiveness
[4] ISO 22716 – Cosmetic GMP - Certifications
[5] Guidelines for Good Manufacturing Practice of Cosmetic Products (GMPC), Council of Europe, Council of Europe, 1 Jan 1995
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