PFE5b Critical equipment is maintained and serviced in Not applicable accordance with the manufacturer’s instructions. Not met Partially met Almost met Fully met or exceeded PFE5c Equipment affecting critical processes and storage Not applicable parameters is identified and monitored to detect Not met malfunctions and defects and procedures are in place to Partially met take any corrective actions. Almost met Fully met or exceeded PFE5d New and repaired equipment is validated before use and Not applicable this is documented. Not met Partially met Almost met Fully met or exceeded PFE5e There are documented agreements with maintenance Not applicable companies. Not met Partially met Almost met Fully met or exceeded PFE5f Cleaning, disinfection and sanitation of critical equipment Not applicable is performed regularly and this is recorded. Not met Partially met Almost met Fully met or exceeded PFE5g Instruments and devices used for procurement are sterile, Not applicable validated and regularly maintained. Not met Partially met Almost met Fully met or exceeded
PFE5b Critical equipment is maintained and serviced in accordance with the manufacturer’s instructions. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5c Equipment affecting critical processes and storage parameters is identified and monitored to detect malfunctions and defects and procedures are in place to take any corrective actions. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5d New and repaired equipment is validated before use and this is documented. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5e There are documented agreements with maintenance companies. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5f Cleaning, disinfection and sanitation of critical equipment is performed regularly and this is recorded. Not applicable Not met Partially met Almost met Fully met or exceeded PFE5g Instruments and devices used for procurement are sterile, validated and regularly maintained. Not applicable Not met Partially met Almost met Fully met or exceeded
Human_Application_Licence_Application_Form_Updated_June_2014_0.docx