Economical production of critical culture media for self-sufficient quality control in a public pharmaceutical industry

Introduction:In the pharmaceutical industry, microbiological control is essential to ensure product safety and efficacy.The use of culture media enables the identification and analysis of microorganisms, thereby enabling the assessment of their distinct characteristics.However, reliance on external suppliers poses challenges, such as substantial costs and quality inconsistencies in inputs.In-house production is a strategic alternative, providing cost reduction, improved reliability, and optimized quality control.Objectives: Evaluate the economic viability of in-house production of critical culture media to cut costs and achieve self-sufficiency. Methodology:A comparative analysis of the purchasing and in-house production costs of three culture media (A, B, and C) was performed over the past three years.Direct costs were estimated using the semiabsolute costing method, which accounts exclusively for inputs and labor, excluding indirect expenses.In addition to the economic evaluation, an operational viability assessment was conducted, considering infrastructure availability, staff training, and regulatory compliance.Furthermore, production quality was examined by comparing failure rates between in-house and commercially acquired batches to determine their impact on process reliability. Results:The implementation of in-house production methods resulted in an average 47% reduction in direct costs, representing only 5.3% of the aggregate production of culture media.Medium B exhibited a 32% reduction, and this was the only medium that demonstrated failures with a 50% rejection rate in purchased batches.Conversely, batches produced in-house exhibited a 3.1% failure rate.Medium C achieved a 47% reduction in costs, while Medium D attained a 49% reduction.In addition to reducing costs, in-house production has demonstrated improved test reliability, reduced failures, and optimized processes. Conclusion:The economic and technical viability of in-house production of critical culture media has led to cost savings and improved quality control.The decline in the failure rate of Medium B (from 50% to 3.1%) reinforces test reliability, ensuring sterility and standardization.In addition, the internalization of production processes enhances sustainability by cutting transport, CO 2 emissions, and packaging waste.Finally, the strategic adoption of internalization is a sustainable solution that fosters independence from external suppliers, optimizes logistics, and reduces indirect costs for the pharmaceutical industry.