A Contamination Control Strategy (CCS) should be implemented across the facility in order to assess the effectiveness of all control and monitoring measures employed by a company. Science is no longer isolated; it is living across the lifecycle of the product/process within a Quality Management System.
With ICH Q9, Q10, ISO and EU all aligned on a risk based approach; a documented contamination control strategy is no longer just an option; it is a requirement per the EU Annex 1 revision.
After years of developing contamination control strategies worldwide, we believe in a proactive rather than a reactive approach to contamination control; given that product and patient safety are paramount in medicinal products whether they are sterile or non-sterile.
By working in conjunction with the various departments to draft the policy as a team; Microrite creates companywide awareness on the importance of contamination control.
This collaborative process by Microrite’s subject matter experts and the company’s own personnel helps the client to be well prepared for regulatory visits.
Important aspects of a documented contamination control strategy:
- Design of both the plant and process
- Equipment and facilities
- Raw materials control
- In-process controls
- Product containers and closures
- Vendor approval – such as key component suppliers, sterilization of components and single use systems, and services
- Process risk assessment
- Process validation
- Preventative maintenance
- Cleaning and disinfection
- Monitoring systems
- Continuous improvement