Microbial Assessment of Retention Samples and Impact 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 call for the need to keep retention samples of liquid preparations in pharmaceutical industries. Seven (7) retention samples of registered liquid preparations (Mist Magnesium Trisilicate Mixture, Paracetamol Syrup, Cough Syrup, Vitamin C Syrup, Gentian Violet, Calamine Lotion and Hydrogen Peroxide) that were not less than two years inside the retention room were collected from two selected pharmaceutical industries and microbiology purity tests were carried out using standard methods.  The results revealed absence of pathogenic bacteria in all the retention samples. The highest values of 46.67 cfu/ml and 30.00 cfu/ml obtained for total viable aerobic mesophilic bacteria plate count and fungi from Cough Syrup and Vitamin C Syrup respectively might possibly be due to the use of sugar and other excipients that support microbial growth. The results show 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 produced followed current good manufacturing practice (cGMP) as shown in the results obtained from the retention samples. Therefore, retention samples play vital role in the monitoring of microbial quality of liquid preparations and subsequently contribute to drug development and annual product quality review in pharmaceutical industries.