Competency information


Critically evaluate key reference texts used in aseptic preparation and produce a short report identifying the strengths and limitations of each resource.


  • 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.