There is a general saying within the life sciences:
“We qualify a system and/or equipment and validate a process”
A system and/or equipment must be qualified to operate in a validated process.
For example:
“You qualify an autoclave, whereas you validate a sterilization process”
Manufacturers should identify what validation and qualification work is done. All systems, equipment, processes, procedures should be reviewed and the manufacturer should decide what qualification and validation work needs to be performed.
Direct, Indirect or No Impact
All facility areas, utilities and process equipment must be assessed and classified as direct impact, indirect impact or no impact following an analysis of their impact on the identity, strength, quality, purity or safety of products manufactured at the facility and also the safety of the operators & environment.
Impact on Quality
Each system or item of equipment having direct or indirect impact on the product quality must be validated. The extent of validation or qualification should be determined by performing the risk assessment of that particular system or equipment.