Intro to Aseptic Production Flashcards
Sterile production takes place on two levels. Name them
1) Industrial - Large scale licensed manufacture
2) Hospital
- Small scale licensed or unlicensed manufacture
Define ‘Sterile’
‘Free from bacteria or other living microorganisms; totally clean.’
To produce sterile products on an industrial scale, manufacturer’s authorisation is not needed. TRUE or FALSE
FALSE. Manufacturers authorisation is needed!
Products produced on an industrial scale are more likely to be those with a marketing authorisation (product license). TRUE or FALSE
TRUE
Name 3 examples of industrial sterile products likely to have a marketing authorisation
1) Mass produced injections
2) Mass produced eye-drops
3) Mass produced dressings
Industrial sterile products should be produced according to good manufacturing practice (GMP) for medicinal products. TRUE or FALSE
TRUE
Explain Licensing
Having manufacturers authorisation to make products to sell to others
What are ‘Specials’
Hospital small manufacture products that do not have a products license
Described hospital unlicensed product manufacture
Hospitals that do not make specials but order from elsewhere instead
GMP is part of quality control. TRUE or FALSE
FALSE. GMP is part of quality assurance
State 11 factors of GMP
- Processes
- Facilities
- Equipment
- Materials
- Procedures
- Storage and transport
- Training
- Record keeping
- Distribution
- Product recall
- Complaints
Quality control is part of GMP and includes …
- Specifications
- Sampling
- Testing
- Record keeping
- Product release
GMP applies to only some medicinal products/ devices manufactured in the EEA. TRUE or FALSE
FALSE. GMP applies to ALL medicinal products/ devices …
Within the GMP is a separate annex for sterile production. TRUE or FALSE
TRUE
State 5 classes of products that need to be produced under sterile conditions
1) Any products for injections (Needles, Syringes)
2) Eye - drops
3) Dressings
4) Irrigation solutions
5) Items used in surgery (Sutures, Implants)
