Competency information
Details
Perform the visual inspection of products
Considerations
- Properties of different types of pharmaceutical products that are manufactured.
- Awareness of processes used in the manufacture of the different types of products.
- Awareness of different equipment used.
- The theory underpinning the manufacturing processes.
- Pharmaceutical aspects of Health and Safety legislation, including Control of Substances Hazardous to Health and accident reporting.
- Different methods of sampling.
- Clean in Place (CIP) and Sterilise in Place (SIP).
- Types of cleaning products.
- Rinsing, drying.
- Storage of raw materials and products.
- Time limits for leaving ‘clean’.
- British Pharmacopoeia requirements for different types of products and consequences of non-compliant products.
- Different equipment used to assist with viewing and British Pharmacopoeia requirements (black/white background, light levels, polarised light, eye tests).
- Importance of daily safety checks, general health and safety requirements, and permit to work systems.
- Awareness of maintenance and calibration requirements.
- Importance of reporting deviations.
- Current in-house training programmes.
- The importance of avoiding cross-contamination.
- Bioburden limitation.
- Sterility assurance level.
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 | Outcome Observe, assist and where appropriate perform, under supervision, a range of processes and procedures in accordance with local practice in order to manufacture products safely (This includes the clothing requirements and handling of waste. The range of equipment used may include autoclaves, dry heat sterilising ovens, filling machines, filter integrity testers, mixers, capping machines, equipment used for the preparation of containers and balances). |