Internal GMP inspections identify minor and potentially significant issues or opportunities that may lead to timely and permanent corrective actions. Audits focus on thorough review and documentation. Root cause analysis is comprehensive and targets prevention
Internal audits are in place and performed at a regular frequency. Corrective actions are implemented & documented. Learnings are shared and effectively communicated across the company with all relevant personnel.
A culture of proper housekeeping and organization should be developed and these behaviors must be consistently applied. Routine monitoring throughout the facility and plant grounds, followed by necessary corrective actions are crit
Temperature control in critical storage areas is maintained and temperature recording devices or indicators are appropriately located and and accesible. Temperature control chart or other temperature collection methods are available. Manual checking and recording are
High pressure water should not be used during production to avoid aerosoling and potentially cross-contaminating the production environment.
Identify hotspots based on exposure of product in the freezer.
Cleaning procedures should be validated, especially if product is exposed to the freezer.
Cleaning frequency should be based on a risk assessment (product exposure to the freezer).
For all media inquiries, please contact:
Mary Emma Young
Vice President of Communications
meyoung@affi.com
443-904-3937
Tel: (703) 821.0770
Email: info@affi.com