Impact of Retention Samples in Monitoring Microbial Quality of Liquid Preparations in Pharmaceutical Industries

Abstract

The impact of retention samples in monitoring microbial quality of liquid preparations in pharmaceutical industries cannot be over-emphasized. The challenge of microbial contamination and monitoring microbial quality of liquid preparations for the benefits of the end users warrant the need to keep retention samples of liquid preparations in pharmaceutical industries. Ten retention samples of registered liquid preparations that were not less than two years inside the retention room were collected from two selected pharmaceutical industries and microbial analyses were carried out using standard methods. The results showed that no pathogenic bacteria were found in all the retention samples. The highest values of 220 cfu/ml and 30 cfu/ml were obtained for total viable aerobic mesophilic bacteria plate count and fungi respectively from the samples. The results indicate that the microbial quality of the liquid preparations represented by the retention samples were satisfactory as they conformed to the British Pharmacopeia (BP) specifications for liquid specifications. This suggests that the liquid preparations that were produced followed current good manufacturing practice (cGMP) as shown in the results obtained from the retention samples.