According to ICH Q10, which of the following statements about implementing a Pharmaceutical Quality System (PQS) is EXCEPT?

Implementing a Pharmaceutical Quality System (PQS) focuses on maintaining and enhancing the quality of pharmaceutical products. According to ICH Q10, which provides guidelines for the development and implementation of PQS, it emphasizes a structured approach to quality management that aligns with manufacturing processes, fosters consistency in product quality, and facilitates continuous improvement.

The statement regarding the reduction in the frequency of inspections is incorrect because while a robust PQS may lead to improved quality and compliance, it does not inherently reduce the frequency of inspections mandated by regulatory authorities. Inspections are typically driven by regulatory requirements and standards, which remain unchanged. Thus, a strong PQS could lead to more efficient inspections, but not necessarily a decrease in their frequency.

In contrast, integrating a PQS with manufacturing processes ensures that quality considerations are embedded throughout production, enabling real-time monitoring and enhancement. The ability to certify a PQS through an established program might vary by region and organization, but it reflects the standardized approach advocated by ICH Q10. Furthermore, implementing a PQS is intended to enhance the consistency of product quality, which aligns with the core objectives of maintaining patient safety and product effectiveness.