A Review on the Microbial Contamination in the Non-sterile Pharmaceutical Products

Abstract

This article aims to review available scientific data dealing with the Microbial contamination that may occur by some environmental factors (temperature, pH, and water activity), these factors are a major problem for the spoilage of pharmaceutical dosage form, and raw material, personnel, and other factor contributing to the transfer of the microbe into the pharmaceutical product. Non-sterile oral pharmaceuticals, including syrups, do not need to be sterile. At the same time, certain quality-control tests and some measures were followed, according to current good manufacture practice (cGMP), which are essential to keep the microbial content of these preparations safe and acceptable. Similarly, may manufacturer failures to comply with the Good Manufacturing Practice (GMP) at any stage of pharmaceutical production may consequently affect the microbiological quality of the product, and ultimately they caused economical loss for industrialists on the spoilage of pharmaceuticals. Microbial contamination in the pharmaceutical products increases from prescribed limits may change their Physico-chemical properties of the dosage form may be chances to hazardous for the immune-compromised patient due to overload microbial contamination. All the components of the non-sterile pharmaceuticals such as API and all kinds of excipients are at risk due to microbe overloaded and spoilage. Strictly the following (cGMP), continuous pharmaceutical surveillance is required to control microbial contamination within the pharmaceutical preparations.