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Pharmaceutical vs. Cosmetic Industries: differences in process validation

Pharmaceutical vs. Cosmetic Industries: differences in process validation
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The validation of industrial processes it does not always follow the same criteria and standards, as each industry has its own specificities that will guarantee the high quality standard of what is produced, delivered to the market and required by the consumer.


For the cosmetics industry, Anvisa's resolution to RDC 48/2013 defines good quality practices for the manufacturing processes of personal care products, cosmetics and perfumes. This resolution, therefore, brings differences inguidelines the quality validation in relation to RDC 301/2019, which is applicable to the pharmaceutical area. Some of these differences are, for example, the applicable criticalities and tests not applicable to cosmetics, such as the case of residual toxicity analysis of a product that is applicable when there is a pharmaceutical active.


What to consider when validating cosmetic products?

Many entrepreneurs in the cosmetics industry have doubts as to what should be considered for a validation of their production processes. Here, we've listed some key factors that manufacturers in this industry should be aware of. Come on?


  • Definition of Criteria for Cosmetic Industry Validation: the relevant parameters of the entire manufacturing process need to be properly validated. To carry out a validation, it is necessary to know about the process and know it through its historical basis. However, such data are for consultation only, once carrying out a "Retrospective Validation", that is, based on historical data, is no longer accepted by Anvisa. Therefore, the need to carry out a “pre-study” when the process to be validated is not known is essential for the definition of acceptance criteria.


For the pharmaceutical sector: RDC 301/2019 defines that pharmaceutical manufacturers either carry out a "Prospective Validation" (in this case, for the product that will still be introduced on the market and, therefore, it is a new process), or carry out a "Concurrent Validation" (here, it refers to the existing product, but which may change as to something inherent to its production process that has been carried out by the manufacturer). For both validation, new protocols andare needed process validation tests. 


  • How to carry out cleaning validation and analytical methodology validation in the cosmetic industry? Cleaning validation and analytical methodology validation are still challenging validations for this sector, mainly because most cosmetic products do not have compendial methods for reference, and because each cosmetic product has its specificity. In this case, RDC 48/2013 requires these validations, but it is up to the companies to define the criteria according to their processes and products. Such criteria can also be defined in “pre-studies”. Computerized systems used for production and/or that have an impact on product quality are also being required to be validated.


For the pharmaceutical sector: both topics are mandatory and with super restrictive criteria in compendials for some cases - not to mention the need for validation of computerized systems adopted in their production processes.


  • Validate the most difficult condition of the cosmetics manufacturing process: To start validation, it is essential to define the “worst case” product, so that it represents all products in the parameters in which it will be challenged. In a cleaning validation for example, identify in the chosen production line the worst case for viscosity, solubility, etc. Through a risk analysis, it is possible to show the most representative product for this choice and which provides the most difficult condition of the manufacturing process. 


For the pharmaceutical sector: In addition to defining the “worst case” product through a risk analysis, assessments of the active toxicity residue in the three consecutive productions evaluated are required. 


Therefore, it is observed that for any of the industries it is essential that the manufacturer observes that, regardless of the type of validation, it must demonstrate that its process, analytical method, system or cleaning is REPEATABLE, REPRODUCIBLE and ROBUST. 


And the process, cleaning or system can only be validated when these 03 factors are met. Validation demonstrates critical production points and is the responsibility of everyone involved (not just quality specialists) on how such points can be improved. In this case, respecting and complying with the defined manufacturing parameters and challenging themselves on how they can improve even further will make all the difference to arrive at an ideal and differentiated product for the consumer. 

See how we, at Kivalita Consulting, can help your company in the efficient validation of processes.


Deeply understanding the requirements of each resolution, as well as their updates, revocations and anticipation of trends, is part of our dailyat routine Kivalita Consulting

We are a Brazilian company, specialized in the development of quality management and validation of technologies that support manufacturers, especially in the cosmetic and pharmaceutical sectors, to prosper in their markets. For this, we help manufacturers to reduce waste, rework and risks that could impact their business.

How about talking to us to learn more about the differences in quality validation between pharmaceutical and cosmetic industry processes? Schedule an appointment with our experts! 

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