Risk based set-up for Analytical Process Control & Monitoring Systems (APC&MS)
by Pablo Moreno, Eurofins Biolab, Italy
Pharmaceutical facilities are required to meet GMP and governing regulations during the entire production lifecycle so that performance verifications, control of processes and monitoring systems are part of the validation lifecycle.
A science risk based approach applied to APC&MS is essential for an appropriate set-up in terms of effectiveness and costs. Mastering numerous projects and with years of experience, Eurofins recommends the following key concepts:
- Product and process understanding:
- An understanding of the supported process is fundamental in determining system requirements, focusing on those aspects that are critical to patient safety and product quality. The final objective of this approach is also linked to the identification of Critical Quality Attributes (CQAs) and related Critical Process Parameters (CPPs).
- Lifecycle approach within Quality Management System (QMS):
- Adopting a system lifecycle approach entails defining activities in a systematic way from system conception to retirement. As experience is gained in system use, the QMS should enable continuous process and system improvements on periodic review and evaluation and root-cause analysis of failures.
- Choose carefully Risk Assessment (RA) technique:
- Since the main cost in development of a QRM system is linked to the time spent of high level human resources, the choice of the RA technique is a very critical point. Below is a comparative table for the most common RA and their applications on APC&MS.
- Analytical techniques must focus the scope of APC&MS:
- In some cases, compendial methods may not be the best choice for APC&MS. Therefore, it would be necessary to undertake method development/validation and/or integrate methods reported in pharmacopoeias with other specific analytical tests.
With the industry's most regulatory compliant capabilities and expertise, Eurofins can support production plants in analysing their approach to APC&MS set-up and implement a validation and monitoring plan based on these findings.
Contact: GMP_EU@eurofins.com
