The assessment for the GxP Risk needs to address the following questions:
- Does this system require validation?
- How much validation is required for this system?
- What aspects of the system or process are critical to product and patient safety?
You can replace system by change, because this risk assessment needs to performed for every change.
Good Engineering Practices introduced the site impact assessment by which the impact on product quality can be assessed. Systems are assessed as to their impact on product quality by answering the following questions:
Does the system come in contact with the product (including systems for air quality)?
- Does the system provide an excipient or produce an ingredient or solvent?
- Is the system used in cleaning or sterilizing?
- Does the system preserve product status?
- Does the system produce data evaluated to accept or reject product?
- Does the system control or manipulate the process in such a way as to affect product quality without independent verification of the control system performance (PLCs, DCS, Loop Controllers)?
Systems are identified as “Direct”, “Indirect” or “No impact” systems. Only direct impact systems require validation. The systems mentioned in your question would classify as direct impact systems. These systems you break down in components and again identify which component has an impact on product. Only for the component which do have an inpact on product you perform an risk assessment. You can apply common risk assessment tools like
FMEA, HAZOP, FTA to identify and quantify the risks.