Science is no longer isolated; it is living across the life-cycle of the product/process within a Quality Management System. Poor cGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient.
The manufacturing of products for human use is subject to special requirements to minimize risks of microbiological, particulate and pyrogen contamination. The following key areas should be considered when assessing risk; these are typically assessed, controlled and monitored individually, but these many sources should be considered holistically.
A contamination control strategy should be implemented across the facility to assess the effectiveness of all the control and monitoring measures employed.
- Design of both the plant and process
- Equipment and Facilities
- Raw Materials Control- including 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 – maintaining equipment and premises (planned and unplanned maintenance) to a standard that will not add significant risk of contamination
- Cleaning and disinfection
- Monitoring systems - including an assessment of the feasibility of the introduction of scientifically sound, modern methods that optimize the detection of environmental contamination