In the competitive cosmetics industry, ensuring product quality, safety and efficacy is not only a regulatory obligation, but a strategic advantage that reinforces consumer confidence and protects brand reputation. Stability reports are fundamental to decision making in the areas of quality, production and logistics, providing key information to maximize product performance and mitigate risks.

Key elements that a stability report should include

An effective stability report must be clear, rigorous and action-oriented. Here are the essential elements that every quality manager should require:

1. Complete product identification

o Product name and formulation reference.

o Details of the presentation (type of container, capacity and other specifications).

Importance: Each formula and presentation has particularities that affect its stability; changes in composition or packaging require new studies.

2. Key dates of the study

o Start and end of the study.

o Intermediate evaluation points.

These dates allow correlating the results with the estimated lifetime and adjusting the production and launch planning.

3. Detailed study protocol

o     Storage conditions evaluated (temperature, humidity, light, etc.).

o     Total duration of the study.

o     Parameters analyzed according to the nature of the product (e.g., viscosity, pH, organoleptic properties).

o     ICH Climatic Zones: Includes studies under specific conditions for zones I, II, III and IV according to ICH international guidelines, ranging from temperate to hot and humid climates.

o     Qualified Climatic Chambers: Studies should be conducted in validated climatic chambers, which allow precise control of temperature and humidity conditions. These chambers should include:

. Testing options with light (lux) and no light exposure.

. Controlled conditions in certified chambers that ensure the integrity of the results.

Importance: A well-designed protocol ensures that the study is reproducible and relevant to real market conditions.

4. Clear and traceable results

o     Presentation of the data obtained at each evaluation point.

o     Methods of analysis used, including advanced techniques such as:

. HPLC (High Performance Liquid Chromatography): For accurate determination of active ingredients and degraded compounds.

. UPLC (Ultra Performance Liquid Chromatography): Allows faster analysis with greater sensitivity, ideal for complex products.

. UV-Vis Spectrophotometry: Used to verify the stability of colorants and other light-sensitive components.

. Other

Importance: Clear and well-documented data allow to identify patterns, anticipate problems and support decisions based on scientific evidence.

5. Conclusions and recommendations

o  Estimated useful life of the product under different conditions.

o  Recommendations for transport, storage and use.

Relevance: These conclusions are essential for regulatory compliance and consumer satisfaction.

6. Validation by a technical manager

o  Signature of the person responsible for the study.

o Certification of compliance with good laboratory practices.

Importance: Validation supports the credibility of the report and its acceptance by regulatory authorities.

Strategic benefits of stability studies

1. Risk prevention: Detecting potential quality problems before distribution minimizes costs due to returns or recalls.
2. Resource optimization: Stability results allow defining the best storage and transportation conditions, reducing losses due to spoilage.
3. Market confidence: A product with guaranteed stability reinforces customer loyalty and improves competitive position.
4. Regulatory compliance: Adequate documentation ensures that the product complies with regulatory requirements, avoiding sanctions and protecting the company’s image.

Stability as a basis for operational excellence

At Dr. Goya Análisis, we have refined our protocols to ensure reliable and actionable results for strategic quality management. By integrating stability studies into product planning, companies not only comply with current legislation, but also raise their quality and competitiveness standards.

A well-prepared stability report is more than a technical document: it is a tool that supports critical decisions and reinforces the company’s commitment to excellence and consumer safety.

Laura Rubio and Iván Parra

Dr. Goya Análisis

CONTACT

iparra@laboratoriogoya.com

www.laboratoriogoya.com