Viral vector and cell/gene therapy facilities can be less complicated and require fewer critical utilities when compared to pharmaceutical or biotech facilities. Such facilities frequently do not have specialized requirements such as low particulate levels or high-quality water systems as many processes are small-scale and enclosed. Viral vector facilities usually require multiple laboratories to perform assays and rooms to house controlled temperature units that require nothing more than adequate power and controlled classified environments. This webinar will discuss risk assessment and qualification that is phase-appropriate for your CGT operation.

From a regulatory perspective, there is ongoing reduction in prescriptive practices and while facility/utility qualification is rarely mentioned specifically, the implication is clear: it is not necessary to undertake the formulaic qualifications of years past. Instead, focused evaluation is limited to areas where assessments indicate higher risk and to those items most critical to intermediate and end-product quality (safety, purity, etc.).

– Be realistic about environmental and utility requirements for closed and enclosed processes

– Consider SaaS and similar to reduce upfront investment for implementation and qualification of computer-based functions.

– Determine the level of QMS and qualification that’s phase-appropriate for your operation

Subject area:
Biologics

Objectives (If applicable):
N/a

Target Audience (If applicable):
Drug manufacturing, pharmaceutical manufacturing, biomanufacturing, biologics organizations; Job function: process design, quality assurance (QA), quality control (QC), operations managers, quality management, pharmaceutical quality directors, MHA, MPH.