6.1.3. SWOT analysis
In order to evaluate the best strategy for the roll out and to ensure coverage of all critical aspects by that approach, a SWOT analysis is set up to evaluate the strengths and weaknesses of the planned roll out of QbD and also the opportunities and threats arising from this approach.
| Strengths |
Weaknesses |
- Full management commitment for top down implementation
- Champions’ expertise in the use of new tools facilitating roll out in the teams
- External consultant providing “guidance” and training
- Stepwise roll out allows for benefitting from lessons learnt throughout the process
- Parallel roll out in all projects will speed up process
- Limited resources in personnel and costs needed for roll out
- Prior experience and knowledge on QbD philosophy available in the teams and the line
- Proactive implementation at own pace not being forced to do so yet
- Successful roll out experiences available in the industry to learn from
|
- No full support from all teams and individuals for QbD
- Additional efforts needed for projects in later phases to fill gaps and missing documentation for QbD approach
- Lack of widespread experience in the use of QbD tools within the teams
- Limited resources available at QbD champions
- Shortage of tools available at the start of the roll out
- Many external contract parties and partners have no prior experience in applying QbD
- No PQS in place to facilitate roll out internally and to external parties
- Risk management so far limited to GMP and QA quality rather then the design of quality
- No IT system available throughout R&D to facilitate Knowledge Management and Continual Improvement
|
| Opportunities |
Threats |
- „Right first time“ (!), not wasting time and money by failing to deliver the necessary quality for filing, transfer or launch
|
- Initial slow down in the projects due to the need to define and implement QbD process in the organisation and teams
|
- Hand over of robust and capable processes to operations or a CMO
|
- No international harmonisation of requirements in the regulatory assessment approach established yet
|
- Pharmaceutical products developed with focus on customer needs - safety, efficacy & convenience
|
- QbD may fail to gain wide spread acceptance in the industry and may disappear like a fad
|
- Less “surprises” shortly before critical milestones
|
- Isolated roll out without integration in the company’s culture and management systems has high risk to fail in providing full benefits
|
- Delivery to the “customer” (clinical study, CMO, production, project management, marketing) on time avoiding repetitive cycles and a waste of time and money
|
- Benefits will be not immediately visible and projects may fail out of other reasons → QbD fails to prove superiority quickly enough to gain full internal acceptance
|
- Avoidance of batch failures and waste during routine production (better contribution margin)
|
- Frontloading of development activities to early phases increases CMC costs and development timelines if not combined with “less is better” decision making
|
- Doing (only) the important = critical things and doing these at the right time to prevent failure or problems rather than doing many things without adding real value → improved quality of project and thus R&D pipeline
|
- Failure due to missing integration with production and /or CMOs
- Parallel QA activities to improve “quality” may cause additional delays and require resources and interface discussions
|
- Establish QA oversight for development and implement new FDA validation guidance without extending the burdens of CGMP on development activities
|
|
Table 4: SWOT analysis fort he roll out strategy of QbD at Pharma Example Ltd.
Both, the weaknesses and the biggest threats of the SWOT analysis are addressed in the roll out strategy in order to fully benefit from the existing strengths and arising opportunities when rolling out QbD for all CMC development activities. Thus the chosen time frame for milestone activities, embedding of QbD into the organisational structure, definition of the interfaces and integration of operations, QA and CMOs and the alignment with other strategic programmes within the company are considered in the plan for the roll out and the set up of a strategy for QbD.
