Competency information
Details
Design a label in accordance with the requirements for labelling medicinal products
Considerations
- Principles of pharmaceutical formulation and processing
- Properties of excipients and ingredients in pharmaceutical products
- Factors affecting formulation, stability and preservation of pharmaceutical product
- Factors affecting the choice of container/closure systems for different types of products – compatibility with product/processes/method of administration
- Advantages and disadvantages of different methods of production, eg terminally sterilised vs aseptic preparation; gassing vs liquid disinfection for isolators
- Limitations of sterilising methods, eg heat labile drug/excipient/container, container effected by methods of sterilisation, eg glass going amber on irradiation
- Labelling requirements
- Tallman lettering
- Judicious use of colour
- Medicines and Healthcare products Regulatory Agency guidance
- Requirements of label adhesive (fridge, permanent, peelable, etc)
- Additional labelling
- Limitations of available facilities and equipment
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Apply the principles of EU Good Manufacturing Practice to develop a safe new product and assess the scope of the licence held by the organisation when considering a new product . |