Competency information
Details
Critically evaluate key reference texts used in aseptic preparation and produce a short report identifying the strengths and limitations of each resource.
Considerations
- Key reference texts, including:
- Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide), British National Formulary (BNF), British Pharmacopoeia (BP)
- Specification of Product Characteristics (SmPCs), CIVAS Handbook, Medicines for Children, Trissel, Martindale etc
- published research data including evidence based reviews
- How the specification for a product is written based on how, when and where the product will be administered.
- How the evidence would affect decisions on allocation of expiry dates.
- Your organisation’s governance arrangements for managing unlicensed products.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 1 | Outcome Complete aseptic manipulation under supervision. |
| # 4 | Outcome Interpret stability data when determining the shelf life of a range of products. |