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RDC 318/2019: How to Conduct Stability Studies for Pharmaceutical Ingredients and Medicines with a LIMS
Learn about RDC 318/2019 and discover how a LIMS can ensure compliance, safety, and efficiency in stability studies for pharmaceutical ingredients.
In the pharmaceutical industry, compliance is synonymous with safety, efficacy, and trust. Ensuring that medicines and active ingredients maintain their quality attributes throughout the entire product lifecycle is not just a regulatory requirement — it is a non-negotiable commitment to public health.
However, this process can be complex, subject to human error and data fragmentation. But did you know that, by adopting a LIMS (Laboratory Information Management System), you can turn this challenge into a precise, traceable, and integrated operation?
Brazil’s Collegiate Board Resolution (RDC) No. 318/2019, issued by ANVISA (Brazil’s national health regulatory agency), establishes the mandatory criteria for stability studies of active pharmaceutical ingredients (APIs) and medicines, with the exception of biological products.
In this article, you’ll learn what RDC 318/2019 is, how a LIMS can be essential for meeting this regulation, and you’ll also find a free, certified mini-course taught by recognized industry experts.
What is RDC 318/2019 and why does it matter?
RDC 318/2019 is a regulation that requires manufacturers to conduct periodic, controlled assessments capable of identifying how specific factors can impact the physical, chemical, biological, and microbiological characteristics of products.
In addition, the regulation applies to a wide range of medicine categories, including generics, new drugs, similar drugs, homeopathic products, herbal medicines, radiopharmaceuticals, and products subject to simplified notification, making its scope quite broad across the sector.
To this end, the regulation requires conducting different types of studies — each designed to reproduce real or adverse conditions of transport, storage, and use, allowing manufacturers to anticipate and control risks that could compromise product stability. These include long-term, accelerated, follow-up, in-use, post-reconstitution, and forced degradation studies.
How LIMS supports stability studies under RDC 318/2019
Meeting the requirements of RDC 318/2019 demands full control over analytical data, processes, and documentation. This is where a LIMS becomes an indispensable ally.
Actiz LIMS, for example, offers a robust platform for managing stability studies, enabling:
- Management and validation of analytical methods
- Traceability of every stage, from planning through to preparing reports for regulatory submission
- Generation of indicators, charts, and alerts for deviations, trends, and nonconformities
- Data integrity assurance
A LIMS enables intelligent management, allowing the company to streamline processes, minimize manual errors, and maintain an operation aligned with good practices and current regulations.
Learn more: How a LIMS ensures complete laboratory traceability
Want to master RDC 318/2019? Take the free mini-course!
Knowing the requirements of the regulation is essential. But even more important is knowing how to apply them in practice to ensure compliance and process safety.
That’s why Biochemie, in partnership with ACTIZ and ER Analítica, developed the free online mini-course “RDC 318/2019 — Stability Studies for Pharmaceutical Ingredients and Medicines“, featuring 4 hours of practical content, a certificate, and 365 days of access.
Learn from renowned experts:
- Ingrid Ferreira Costa — CEO of Biochemie, specialist in Good Practices, ISO standards, and laboratory management.
- Raquel Cardoso Machado — PhD in Chemistry, specialist in analytical method development and spectrometry.
- Renato Rainho — Director of ER Analítica, a reference in calibration, metrology, and equipment control.
- Felippe Domingos — Chief Technology Officer and Co-founder of Actiz.
Mini-course syllabus:
1. Objectives of stability studies for medicines and APIs
2. Applicability of stability studies throughout the product lifecycle
3. Defining storage conditions for different climatic zones
4. Development and validation of stability-indicating analytical methods
5. Acceptance criteria for physicochemical and microbiological parameters
6. Experimental planning and study design (long-term, accelerated, follow-up)
7. Specific studies: in-use, post-reconstitution, and dilution
8. Presentation and interpretation of data in regulatory dossiers
9. Continuous monitoring strategies and shelf-life extension
10. Harmonization with international guidelines (ICH, WHO, Mercosur)
If you work in, or want to work in, the pharmaceutical industry and want to ensure full compliance with ANVISA’s requirements, this course is for you. Access the free mini-course now and strengthen your compliance with RDC 318/2019.
Actiz LIMS: your foundation for ensuring quality and compliance in stability studies
eActiz LIMS was developed to meet the most rigorous standards of the pharmaceutical, chemical, sanitizer, food, and cosmetics industries, offering a robust, scalable platform that is 100% compliant with the requirements of RDC 318/2019 and other applicable regulations.
