Annexes 6, 7, 9, 3, 10 and 12 Flashcards
(38 cards)
What is Annex 6
Medicinal Gasses
Which bit of med gas is drug substance and which drug product
Production and purification = AS
1st storage of gas for use = DP
What conditions for storing gasses
Under cover and protected. Segregation from non-medicinal gasses
What special points about equipment for gasses?
Control any adaptors used carefully to avoid cross contamination
Tanks and tankers should be dedicated. Can also be used for non-med if same quality and GMP maintained
Need to analytical testing when reusing for med gas after doing non-med
Cylinders / valves etc need traceability
+ve pressure to be maintained (even when nominally empty). If not +ve then assume contaminated.
What requirements for water used for hydrostatic testing?
At least drinking water
What release tests for gasses?
Assay from one cylinder of each fill unless mixed gasses through a manifold then test each cylinder (pre-mixed gasses can be considered single gas).
Water content
Assay & identity for each cryogenic vessel
NO REF or RET SAMPLES unless otherwise specified
What is Annex 7
Seventh heaven - herbals
What are the things to worry about when storing and processing herbals
Dust control – cross contamination risk
Pest controls – insects and rodent spoilage
Micro – fermentation / mould spoilage
Humidity / temperature / light controls
What tests for herbals?
Identification of active or markers.
Water content
Assay of active or markers
Pesticide residue test
Fungal / microbial in aflatoxin, mycotoxins, pest contamination test
Toxic metals and any other likely contaminants
Foreign materials
What info needs to be documented for herbs
Scientific name
Source
Part of the plant
Drying system if dried
Description
What are the special things about sampling herbals?
Need experience as heterogeneous
Reference samples both milled and unmilled needed unless in pharmacopoeia
What is Annex 9
Liquids, Creams and Ointments
Lotions and potions
What are the concerns with liquid manufacture?
Micro and PCCE contamination
Cleanability of design, no glass if poss, closed systems
Mixing – esp. at start, after stoppages and at end of filling
What is Annex 3?
Radiopharms
What do you need if the release is before all QC tests due to short shelf life?
Documented procedure of the whole release procedure inc responsibilities and continuous assessment of the QA system
Is Reactor / Cyclotron production covered by GMP
Nope
What does the manufacturer of the final dp describe and justify
Which processes are GMP part I and which are part II
How long for radiopharm records?
3 years unless national reqs are different
What’s different with labelling radiopharms?
Due to radiation exposure, it is accepted that most of the labelling of the primary pack is done prior to manufacturing.
What do you need to do when you need to distribute the radiopharm before the tests are completed?
2 steps with procedure needed –
assess BDs and analytical testing performed thus far and then final assessment in all deviations.
If cant get all tests before use of the product then conditionally release the product before use and finally certify after all results are in
What does there need to be if using before all test results are in
A procedure for what the QP – inc CAPA and telling the clinician responsible persons. Therefore traceability system needs to be maintained.
Product shouldn’t be administered by the receiving institute until satisfactory rest results are received
What are hot-cells
A nuclear isolator….
Shielded workstations for manufacture and handling of radioactive materials. Hot-cells are not necessarily designed as an isolator.
How long should radiopharm starting material reference samples be kept
2 years after the release of the product
How long should radiopharm reference samples of bulk be kept
6-months after expiry date
