Continuous Improvement in the PQS

To that end the PQS does not stop once you have completed a successful inspection. What is just as important is the mindset of pro-actively identifying issues before they become problems and improving your systems accordingly. There are two principal approaches that can be taken in this regard:

• Monitoring of the PQS
• Monitoring of Regulatory Intelligence

Monitoring of the PQS:

Every company should be actively monitoring their PQS through regular management review, this is an expectation of the EU regulators and is prescribed in Chapter 1 of the EU GMP Guide. Correctly used these management reviews can provide an early warning signal, particularly if the data related to CAPAs, Change Control and Deviations is scrutinised. Repeat deviations or ineffective CAPAs may be an indicator of a procedural problem that requires a more thorough review or improvement rather than a quick fix. Multiple temporary changes in a process may be masking a need for a comprehensive improvement.

Self-inspections are also a key tool with which to identify process improvements, particularly when performed by someone unfamiliar with the area and who is not afraid to ask the silly questions. Remember that self-inspections are the opportunity to self-identify and self-correct before a regulator is on site.

Monitoring of Regulatory Intelligence:

Knowing what your procedures tell you is one piece of the puzzle; another piece is understanding not just what the regulators are expecting to see but also what the regulators are looking to in the future. Having an active program of reviewing FDA 483’s, EU Non-compliance reports and monitoring regulator websites for planned updates and concept papers can help to inform companies about what direction legislation is heading in and can afford companies the opportunity to plan ahead and in doing so be ahead of the curve.

Having a continuous improvement mindset within a quality organisation benefits not just your product and patient but also your employees and leads to a mature PQS. Look out for our next article on fostering and embedding a mature PQS in your organization.

At MIAS we have a wealth of experience in assisting clients to improve their existing systems. This is informed by our own Continuous Improvement initiatives which has helped us to complete every regulatory inspection of MIAS with no major findings.