Discover how one of the national references in the pharmaceutical industry improved its Cleaning Validation in the Sterile Liquid Production area.

RRBL, a company in the NC group, a pharmaceutical company located in Brazil that develops and manufactures complex sterile injectable drugs, such as Liraglutide, recently used the power of Minitab, another reference in its respective sector, to improve statistical analyses in its laboratories.

With a vast portfolio of quality, safe and effective drugs, RBBL has a highly qualified team, with a new and modern factory and laboratories, all governed by a quality system designed to meet the highest requirements of international regulatory agencies (FDA, EMA and ANVISA).

Recently, the company was faced with the challenge of conducting an adequate statistical evaluation for the physical-chemical and microbiological data from its Cleaning Validation studies in the Sterile Liquid Production area.

Amidst the analysis of so much complex data, Minitab provided a set of robust statistical tools for performing a descriptive evaluation of each relevant piece of data, for example, through preliminary dispersion analyses, such as the coefficient of variation, as well as more complex tools such as control charts and stability graphs, which allowed the results of the Cleaning Validation studies to be evaluated and ensure the compliance of the drugs produced, in terms of quality and safety.

“RBBL is expanding rapidly to produce complex and highly demanded drugs in the pharmaceutical market. In this sense, the partnership with Software.com.br has been essential for optimizing internal processes, since the Minitab tool allows the data generated by the company to be evaluated quickly and accurately, allowing resources – which would otherwise be used to perform analyses using tools that would require more hours of work – to be reallocated,” says Adson Gonçalves, Senior Validation Analyst at RBBL.

As official Minitab partners in Brazil, we are proud to be part of a case study in time and cost optimization within a segment that is so important to the national economy and the health of all of us. Count on Software.com.br to provide your company with the solution you need with a reliable supplier and services for implementation, training, support, license expansion and much more.