Competency information
Details
Assist in writing/reviewing the standard operating procedure/batch manufacturing record
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 . |