Microbiological quality control of non-sterile pediatric pharmaceutical products
Pharmaceutical pediatric products—whether sterile or non-sterile—must meet the relevant microbiological quality standards to ensure safety and efficacy. During production and use, many pharmaceutical pediatric products are vulnerable to contamination from a wide range of microbial species. Young children under 5 years of age and infants are particularly vulnerable to harmful and accidental infections due to their immature immune systems and limited prior exposure to antigens. When these young children consume pharmaceutical preparations of inadequate microbiological quality, they may be exposed to serious health risks. Maintaining the safety and efficacy of non-sterile pediatric pharmaceutical products, as well as safeguarding children’s health, depends on their microbiological quality. Pharmaceutical pediatric products are widely used in India; therefore, it is essential to assess their microbiological quality and overall safety. This study examines the microbiological quality of 26 pediatric drug products. Using compendial methods, the pediatric drug products were analyzed for the presence of specified microorganisms, total yeast and mold count, and total aerobic microbial count. Based on the study’s findings, three of the pediatric drug products showed microbial contamination levels above the maximum acceptable limits specified in the Indian Pharmacopoeia. The pediatric drug products under examination did not contain the specified microorganisms, including Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. It is advised that current good manufacturing practices and appropriate hygiene measures be strictly followed when manufacturing, handling, and dispensing these products; therefore, microbial quality control is crucial to prevent contaminated products from reaching the market and to protect public health.
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