ABSTRACT:
Preventing contamination is one of many key factors when making pharmaceuticals because any type of contamination would negatively affect the safety, quality, and effectiveness of pharmaceutical products and the health of the people using those products. Pharmaceutical Contamination can occur as a result of microbes, particulate matter, chemicals, endotoxins, and cross-contamination from a number of sources, including manufacturers (staff), materials (raw), utilities (electricity, water, etc.), equipment (machinery) and the manufacturing environment (cleanroom).Controlling the sources of contamination within a pharmaceutical manufacturer is necessary in order to maintain the integrity of product and to achieve consistent manufacturing operations. Due to the necessitated need to minimize contamination risks and meet regulatory standards, manufacturers of pharmaceuticals must develop a Contamination Control Strategy (CCS). A well-designed CCS incorporates multiple levels of control throughout the entire manufacturing process in order to provide for product quality and regulatory compliance. The CCS shall also be in alignment with appropriate regulatory requirements such as cGMP, ICH guidelines Q9, Q10, regulations found within the EU cGMP Annex 1, FDA guidance documents, WHO guidelines, and ISO guidelines.