In a consulting project with a South American pharmaceutical manufacturer, Zamann Pharma Support was asked to help validate a new Purified Water (PW) system. Although the equipment was reliable and the vendor qualified, the project lacked a solid risk assessment.
Critical parameters had no clear justification, and worst-case conditions remained unchallenged. Consequently, the project required a major reassessment, delaying validation by months and increasing costs.
Our team assessed the validation strategy, identified critical gaps, and highlighted the need for stronger risk-based controls.
Our team supports the planning, execution, and maintenance of qualification and validation activities, including IQ, OQ, and PQ, to keep GMP-regulated systems compliant and under control.
Microbial limits and TOC acceptance criteria require documented scientific justification. The assessment should consider applicable pharmacopoeial requirements and connect the selected parameters to the PW system’s risk assessment. In this case, missing justifications contributed to the need for reassessment.
Worst-case testing challenges the operating conditions considered critical to the PW validation strategy. It helps demonstrate whether qualification evidence supports the selected conditions and acceptance criteria. In this case, the team had not adequately challenged worst-case conditions, weakening the validation approach.
Missing parameter justifications, inadequate worst-case evaluation, undocumented flow velocity rationale, and weak lifecycle planning can undermine a PW validation strategy. In this case, these weaknesses led to a major system reassessment, delaying validation by months and increasing costs.
