Present day pharmaceutical product manufacturing is a highly regulated industry with demanding expectations regarding regulatory compliance. In addition, the regulatory directives and guidelines and the expectations from regulators are ever evolving, as a result of incidents and audit observations. Therefore it can be challenging to stay up-to-date on developments and recognize what risks might lurk around the corner.
To help you we have developed several Quickscans for performing a thorough evaluation of your systems within one to two days, which will provide an overview of the current status and highlight areas at risk or in need of improvement. The areas at risk will be ranked in order of criticality, and presented in a ‘traffic light’ model. In our report we will also indicate differences in the levels of risk.
Our Quickscans are based on the FDA QSIT method (Quality System Inspection Technique) and they are executed as a question-based review, in close collaboration and in an open and transparent way with your applicable subject matter experts.
At this moment we have Quickscans available in the following areas:
- General Compliance
- Cleaning Validation
- CMC Time to Market
- Quality Control Activities
- Lean Six Sigma
The General Compliance Quickscan can serve as an initial inspection readiness scan, and in combination the complete set of Quickscans could function as a more extensive inspection readiness scan; e.g. as the initial step in preparing for a pre-approval inspection.