A recent case from Denmark demonstrated that senior management really is responsible for GMP compliance. The Danish Medicines Agency (DKMA) has now taken an action that reinforces senior management responsibility in a very significant way: they demanded the replacement of the CEO!
It’s important that senior management understand their critical role in implementing a compliant Pharmaceutical Quality System (PQS) and in creating a good quality culture.
Share this with your senior management.
The FDA’s newly formed Office of Pharmaceutical Quality (OPQ) will update its GMP inspections process to add risk-based factors to give sites with higher risk more attention and reward sites that exceed basic compliance.
This New Inspection Protocol Project (NIPP) changes GMP inspections by standardizing data gathering during inspections, using a question-answer based reports with a semi-quantitative scoring to allow for comparisons within and between sites, and a common inspection report structure.
The NIPP program is expected to start in 2017 as a pilot program to collect feedback and experience from the inspectors before it is formally implemented. As FDA inspections become more transparent and semi-quantitative, it is bound to be mutually beneficial to both FDA and the industry. The program was one of the 5 areas of priority for OPQ.