Pharmaceutical Quality Management
With the advent of out-sourcing of pharmaceutical products especially by Americas and the western world, pharma products have to meet international standards. This is not possible if quality is built into the product all the way through its trajectory from birth i.e. production development till marketing and administration to patients.
Therefore, all materials that get into a pharmaceutical product need to be closely scrutinized for its quality aspects. A commonly used excipients in formulation is color. Although, the percentages of color used in pharma products is quite low, the effect of color on formulation stability or ability of coloring ingredient for destabilizing products is well known.
Presence of microorganisms in large numbers in drugs and cosmetics preparations is undesirable since it may lead to spoilage of products. The product can change in color, consistency or manifest visible growth.
Furthermore, presence of microbial contaminants would constitute a potential hazard to public health although reports on contaminated cosmetics are rare.
A critical component involved in color stability is the microbial load. Some preliminary work on microbial contamination in cosmetics has been reported absent twelve years back from this laboratory. The earlier work in this field has been reported by Doren , Woodward , Riger , Wederburn, Kalings and Bruck .
Various sources of contamination by microorganisms have been enumerated . Raw materials are likely sources of microbial contamination and should be examined microbiologically on a routine basis. Even IP, BP and USP have recognized this fact and have set standards for total number of aerobic bacteria in a variety of products for e.g. gelatin, aluminum hydroxide gel etc. A published report by FIP working party indicated presence of high levels of microorganism not only in substances of animal and vegetable origin but also of synthetic or purified
substances including talc, kaolin, vitamins, lactose etc.
Dye colors and their lakes used for improving the elegance of the medicines and cosmetic products could become a potential source of microbial contamination in these formulations. Although the colorants are evaluated for their toxicity, their safety as regards the microbial contamination has attracted very little
attention of the regulatory authorities. The methods for evaluation of medicinal preparations are given in official compendia while those for cosmetic preparations have been adequately described by Lucas (Ref 9-12).
With this background and the fact that, the regulatory authorities might include the limits of microbes in colorants work on lakes manufactured by one company has been undertaken. The contents of the case study disclosed here is authentic. This article is published here in to give an update of our research findings to the scientific community at large with out compromising in any way the confidentiality of the matter with all associated with this work.