Elements and Performance Criteria
- Scope the development project
- Confirm details of new product/application brief
- Specify new product/application requirements
- Analyse existing products (internal and external to enterprise) to determine if they meet customer need
- Interpret and apply relevant Acts, regulations and codes of practice
- Prepare product development plan
- Obtain approval for development plan from appropriate personnel
- Set scope of project
- Develop new product formulation
- Prepare documentation for new product pilot batch
- Evaluate/recommend materials for new product/application
- Calculate required quantities of materials and adjust for properties as appropriate
- Develop/modify products in pilot batch scale in accordance with enterprise and regulatory requirements
- Arrange for product evaluation against development brief
- Modify product/application to meet evaluation recommendations
- Edit documentation and issue to appropriate personnel
- Recommend and evaluate packaging for new product/application
- Prepare protocol for stability (shelf) testing of new product/application
- Assist in preparation of quality/regulatory compliance procedures/materials
- Develop in-process and laboratory testing protocols
- Prepare product labelling and submit for approval
- Assist in product and analytical method validation
- Implement an effective plant hygiene and asepsis program, if applicable
- Develop good manufacturing principles for medicinal products (GMP)/principles of good laboratory practice (GLP) protocols for approval by appropriate personnel
- Prepare standard operating procedures (SOPs) for quality and laboratory related procedures
- Prepare occupational health and safety (OHS) procedures for the laboratory and manufacturing environment and submit for approval
- Document and report project outcomes