6.1.5. Milestone plan for the roll out

The milestone plan defines the activities and timelines for the focus areas during the roll out. During the first phase of the roll out the focus lies on a systematic approach of development (quality target profile, development activities based on criticality and customers’ needs rather than standard approaches) and the Quality Risk Management (assessment & ranking & mitigation plans for all technical risks). As such there are several steps defined in order to establish a fully integrated system within 2 years.

• Nomination of “model projects” for the initiation phase: 4 projects for oral solid dosage forms, as oral dosage forms appear to be easiest for the start as several mock up examples have been published
• Decide on software packages for DOEs, QRM and multivariate data analysis as harmonised corporate tools
• QTPP for all projects
• Define necessary training program
• QRM/FMEA for all projects
• Define necessary procedure and templates for Knowledge Management and Control Strategy
• All projects will use QbD (extent of activities depends on project risks and status)
• Align with production unit to ensure hand shake for quality from design into production

The milestones for the stepwise roll out are also presented in Figure 11 below.

Figure 11: Roll out of QbD at Pharma Example Ltd. - a stepwise approach⁶⁵

⁶⁵ Source: author