Progress-PME has gained wide experience in Cleaning Validation with several successful improvement projects.
We have assessed the current state of Cleaning Validation management and implemented successful, evidence-based improvements for multiple pharmaceutical clients. Regulators, companies and customers in the pharmaceutical manufacturing industry remain highly focused on Cleaning Validation. Virtually every pharmaceutical or biopharma company we work with is interested in a compliant, pragmatic and risk based Cleaning Validation approach. Progress-PME believes that integrating Cleaning Validation in an effective Quality System supported by Quality Risk Management assures that:
- Operational cleaning efforts are balanced with (Cleaning Validation related) risks to patients.
- Operational cleaning processes and their risk related attributes are understood, assessed for impact, validated and mitigated as required.