Annexes 2, 5 and 14 Flashcards
(31 cards)
What is in Annex 2
Manufacture of biological active substances and drug products for human use
What are particularly important for this class of medicines? (Atmps)
QRM – more variability and contamination than you can shake a stick at
What’s different about health of personnel with biologics
Personnel engaged in production, maintenance, testing and animal care (and inspections) should be vaccinated and have regular health checks if needed
Any changes in the health status of personnel, should preclude work. appropriate records kept.
Production of BCG vaccine and tuberculin products should be carefully monitored by regular checks of immunological status or chest X ray
Dedicated or multi product premises for biologics?
Dedicated please.
Multi is OK but there are a lot of additional stipulations in the annex
What premises things have more emphasis for biologics?
HVAC,
drains need to decontaminate the effluent,
pressure cascades if need neg pressure for safety
What additional concerns for stuff derived from animals
TSE
Disease – zoonotic for patient and in the animal sources.
Decisions dedicated.
What do you need to do if have disease in animal
Document and assess. Include look-back to other products that used that animal
What’s required for traceability of starting and raw materials when human cell or tissue donors are used?
Full traceability is required including all substances coming into contact with the cells or tissues through to confirmation of the receipt of the products at the point of use.
Records to be kept for 30 years AFTER expiry date
What’s the approach when the starting and raw material tests take a really long time?
It might be OK to process starting materials before the results of the tests are available.
If so, the risk of using a potentially failed material and its potential impact on other batches should be clearly understood and assessed under the principles of QRM.
Release of a finished product is conditional on satisfactory results of these tests.
What’s the favourite method for sterilising starting materials?
Heat
If not then can use irradiation and filtration
What’s the directive for tissue and cell sampling
2004/23/EC – mandates they are released by an RP at the origin site
Talk to me about doubling?
The number of generations / doublings between cell bank, the active biological substance and the finished product should be consistent with specifications in the MA or CTA
What’s considered a short shelf life?
<14 days
What does the annex say about the release process for short shelf life products?
It’s a 2-part release:
Part 1 = Assessment by designated person(s) of batch processing records, results from environmental monitoring (where available) which should cover production conditions, all deviations from normal procedures and the available analytical results for review in preparation for the initial certification by the Qualified Person
Part 2 = final certification when the results are in
If you’re getting starting material from third-country abattoirs then what’s important
Need to be equivalent to eu
What is IgE
Immunoglobulin E (IgE) is an antibody that plays a key role in allergic responses. It is produced by the immune system in response to a possible invader.
What are Allergoids
Allergens which are chemically modified to reduce IgE reactivity
What are Antigens
Substances (e.g. toxins, foreign proteins, bacteria, tissue cells) capable of inducing specific immune responses
What is Ex-vivo
Where procedures are conducted on tissues or cells outside the living body and returned to the living body
Define Monosepsis
A single organism in culture which is not contaminated with any other
Define axenic
A single organism in culture which is not contaminated with any other
What are Somatic cells.
Cells, other than reproductive (germ line) cells, which make up the body of a human or animal
What does autologous mean?
from the patient cells
What does allogeneic mean? v
from another human being
