Pharmaceutical Process Validation: Product Quality, Safety and Efficacy

Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step. The result is consistent product quality. It seems straightforward but how does one achieve this when it involves a myriad of multiple systems (PLCs, HMIs, control systems, etc.) and requires a team effort that encompasses people from various disciplines within the plant? First and foremost, it is important to design processes that ensure product quality, safety and efficacy. Today’s software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right way. For instance, these systems can deliver clear documentation, provide version control for the multitude of systems in use and backup to ensure all risks are mitigated. Software systems have become instrumental as validation expands from analytical methods used for the quality control of drug substances and drug products to computerized systems for clinical trials, labeling or process control. Quality cannot be adequately assured merely by in-process and finished product inspection or testing. Validation must happen at each step of a manufacturing process, which involves lots of team members from engineers to quality control to compliance officers, etc. to assure that the finished product meets all quality attributes, including specifications.