Mass-produced pharmaceuticals have come far since the industrial manufacturing of synthetic drugs at the end of the 19th century1 with rapid advancement in technology, process control, and sterility requirements. Yet even as improvements to Pharma develop and stick, recalls still occur with regularity2 and their significant impact on both the manufacturer and consumer are why worldwide regulation of the industry is so enforced. Environmental monitoring (EM) is one facet of the greater picture of current good manufacturing practices (cGMPs) that has been standardized for the safety of human health.
Past focus was placed on sampling methods for the measurement of potential contamination: particle counters, active air samplers, Petri dishes, and swabs for surface monitoring. Bioburden of bulk product and filter integrity were also tested to increase the detection of microbiological contamination along the production process. This approach has been remodeled to prevent and control potential contamination from reaching the point of no return: the product. Once contamination occurs, there is no cost-effective removal scheme to continue production, making the determination of sources all the more important. This is achieved by:
- Implementing Quality by Design into the manufacturing area.
- Using quality risk management to identify the critical control points (CCPs).
- With the CCPs, identifying the process phases where it is necessary to establish mitigation actions to control the identified risks.
The collective execution of controls is called the contamination control strategy (CCS). This paper outlines defining the CCS and designing the cleanroom that can achieve contamination control.