The era of end-process testing seems to be over. The adoption by the pharmaceutical industry of new practices and methodologies aimed at increasing their efficiency and flexibility has made it possible for both the industry, with the aid of pharmaceutical consultancy, and its regulating bodies to benefit from a quicker and more economic way to ensure quality and protect public health.
Adoption of lean compliance, quality systems and documentation systems is leading the industry to view the way they’ve been doing business for the past decades and move toward waste reduction, inventory reduction, higher capacity utilization, higher productivity and attempt to achieve the goals of zero lost information, zero defects, zero bureaucracy, zero misalignment, and zero lost opportunities.
The focus of lean systems is to eliminate waste and reduce processes to their most streamlined and value-adding expressions. The same definition of such processes, their investigation and streamlining to achieve control brings the opportunity to install quality and documentation systems within the process streams that facilitate operational compliance.
End-process testing for compliance made the incentive for process streamlining and other efficiency-seeking measures extremely low. Once a process at a pharmaceutical operation is validated as compliant any change to it is viewed as a potential source of problems;, the possibility of lost production, regulatory satisfaction problems, added testing needs, and other undesirable circumstances.
With lean compliance systems, both regulatory bodies such as the FDA and the industry at large can now look at a quicker compliance process that reduces burdens to both sides.
The current lower revenue and margin environment has not been kind to the pharmaceutical industry, and will probably take a couple or more years to overcome. However, these circumstances have made the reward for change more appealing and brought the opportunity to bring flexibility and efficiency into the development and manufacturing of drugs, incorporate quality systems that allow for easier regulatory approvals, and in general bring forth changes that will make our industry more competitive in the long run.
