Training activity information
Details
Critically appraise a plan for the development of a new product including:
- Formulation
- Packaging and labelling
- Manufacturing methods
- Shelf life
- Product specification
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Communication with key stakeholders
- Regulatory standards
- Pharmacopeial requirements
- Product use, including administration route and patient factors
- End user needs
- Sourcing starting material and packaging components
- Validation
Reflective practice guidance
The guidance below is provided to support reflection at different time points, providing you with questions to aid you to reflect for this training activity. They are provided for guidance and should not be considered as a mandatory checklist. Trainees should not be expected to provide answers to each of the guidance questions listed.
Before action
- What evidence will indicate that you have critically appraised the plan effectively?
- What specific insights do you hope to gain regarding the interdependencies between formulation, packaging, manufacturing, shelf life, and product specification in new product development?
- Reflect on your current understanding of each of these aspects. What gaps in your knowledge do you anticipate this activity will help to address?
- How do you expect this activity will enhance your ability to apply the principles of good manufacturing practice (GMP) to the development of new products?
- Discuss the requirements of this appraisal with your training officer to ensure a clear understanding of the expected depth and breadth of the critique.
- Consider potential challenges in critically appraising each element of the plan. How will you prepare to address these, e.g., by reviewing relevant guidelines or literature?
- Identify how you currently feel about appraising such a comprehensive plan. What steps can you take to approach this activity with a proactive and analytical mindset?
In action
- Pay attention to your actions in appraising the plan.
- How are you approaching the critical appraisal of the formulation, packaging and labelling, manufacturing methods, shelf life, and product specification? Why are you doing it this way?
- What decisions are you making as you evaluate different aspects of the new product development plan? For example, how are you deciding which areas require more scrutiny?
- How effective are your actions in identifying potential strengths and weaknesses in the development plan?
- What challenges are you facing as you critically appraise the various components (formulation, packaging, etc.)?
- What can you learn from the process of appraising this plan as it unfolds? For instance, are you identifying gaps in your own knowledge?
- How does this activity of appraising a new product development plan connect to your existing knowledge of Good Manufacturing Practice (GMP) and pharmaceutical quality management systems?
- Are there alternative approaches you could be considering for critically appraising the plan? For example, are you focusing on individual components or the interconnectedness of the plan?
- What support or guidance might you need in the moment if you encounter aspects of the plan you are unsure about?
- Are you working within your understanding of pharmaceutical production and regulatory requirements as you conduct your appraisal?
On action
- What were the key components of the product development plan that you critically appraised?
- What aspects of the formulation were detailed in the plan?
- What information was provided regarding packaging and labelling considerations?
- What manufacturing methods were outlined, and what level of detail was provided?
- What were the proposed shelf life and the rationale behind it? What were the key elements of the product specification included in the plan?
- Did you notice any areas of the plan that were particularly strong or weak?
- What assumptions were made within the plan that you identified?
- What did you learn about the interdependencies between formulation, packaging, labelling, manufacturing methods, shelf life, and product specification in new product development?
- Did you gain a better understanding of the critical considerations for any of these specific areas?
- What principles of good manufacturing practice (GMP) did you consider during your appraisal?
- Did you identify any potential risks or challenges associated with the proposed plan?
- How did this activity enhance your understanding of the role of a clinical pharmaceutical scientist in product development?
- How will you approach the critical appraisal of product development plans in the future?
- What specific aspects will you pay closer attention to, based on this experience?
- How will this learning inform your understanding of pharmaceutical quality assurance and patient safety?
- What further information or resources might you need to develop your skills in this area?
Beyond action
- Have you revisited your initial appraisal of the new product development plan since completing this training activity?
- Consider if your understanding of the interconnectedness of formulation, packaging, labelling, manufacturing methods, shelf life, and product specification has evolved through subsequent experiences.
- Have you discussed your appraisal or the principles involved in new product development with peers or colleagues?
- Has this changed your perspective on any aspects? When reviewing other training activities or experiences related to production or quality assurance, have you reconsidered any of the assumptions or conclusions you made during this appraisal?
- How has critically appraising a new product development plan influenced your approach to evaluating existing pharmaceutical products or processes in your current practice?
- Have the considerations around formulation, packaging, labelling, manufacturing methods, shelf life, and product specification informed how you now approach other tasks, such as reviewing batch documentation or deviation reports?
- Can you identify specific skills or knowledge gained from this appraisal that you have since applied in other areas of your training or work, such as communication skills when discussing product requirements?
- How has this experience contributed to your understanding of the principles of good manufacturing practice (GMP) in relation to product development?
- What transferable skills, such as critical thinking and attention to detail, did you develop through this activity that will be valuable in future product development or quality assurance roles?
- How has this experience shaped your understanding of the complexities involved in bringing a new pharmaceutical product to market, and how might this inform your future decision-making?
- What further development or learning needs did this appraisal highlight in relation to product development, and what actions will you take to address these in the future?
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Apply the principles of good manufacturing practice (GMP) to the development of new products. |
| # 4 |
Outcome
Apply the principles of supplier approval and quality assessment to evaluate a range of starting materials and packaging components. |
| # 6 |
Outcome
Apply the principles of quality risk management to the manufacturing process. |