Compliance Booster for Flawless Drug Manufacturing
The pharmaceutical industry is highly regulated. National and international standards and regulations, such as Good Manufacturing Practice (GMP), are becoming increasingly important, if not a prerequisite for conducting business.
Companies are allocating significant resources to ensure regulations are implemented and processes are validated. However, regulations usually only provide broad guidance (e.g. measuring devices must be calibrated) and leave it to the manufacturer to define the criteria to ensure regulatory compliance (e.g. how often to calibrate). This intentional vagueness provides the necessary flexibility to the manufacturer to adapt quality control procedures to the specific process requirements, but it also contributes to uncertainty about which practices are sufficient. Thus, an in-depth understanding of the regulations, processes, technology and metrology is essential to ensure compliance.