Packaging Flashcards
What do you expect to be printed on the blister strips?
Drug name
dosage form
strength
MAH
Variable data
LOT/EXP
What is printed on outer packaging?
Name
Strength
Dosage form
Quantity of units
Quantitative statement including excipients
Directions for use
Keep out of reach of children
MA Holder name and address/ MA number
Storage conditions
Precautions
Legal status
Batch Number
Expiry date
Serialisation information (EU)
How are packing components controlled at the supplier?
Pharmacopeia standards for packaging materials
GMP requirements for packaging component suppliers outlined in 9000:2016
Supplier assurance
Security barcodes on packs to 100% verify
Run webbing to plain print
Control of back to back manufacture for similar ‘looking’ components.
Describe the chain of systems in place in artwork control
New/variation to artwork initiated
Regulatory text generated based on CDT module 3 requirements
Artwork created by graphics team- secure file, revision history
Cross functional team check artwork text/ compliance
Final copy approved and stored
Secure transfer to print
Proof print is generated and compared to original requirements (colour, dimensions, text)
Approval prior to scale up and print
What would you expect to be in place for incoming packing components to the packing facility?
Incoming receipt- check storage/handling/Damage/evidence of tampering
Check labels are correct and receipt into system
Sample components based on approved procedure- Risk based and ISO2859.
Sample environment meets needs of component
Check samples versus specification;
Appearance, Dimensions, ID/Purity, Micro, text accuracy.
Stored to required conditions and re-test data applied
Describe a typical oral solid dose packing line.
What are the IPCs?
What are control measures?
Primary ‘Cells’ where bulk material and product contacting components are processed. Grade D.
Secondary and tertiary packing in unclassified areas
Bulk material feed>Pocket formation (cold/heat)>Camera check>lidding foil applied>blister seal>Printing of primary component>stacking>leaflet insertion into cartonner>variable data printing>TEL application>tertiary packing.
IPC/ Control measures
Line clearance activity to clear material of previous order
Incoming material/ receipt area for bulk and components
Checked and ensured correct for order in RTL process
Start up checks for line-
Verification challenge tests,
camera challenge tests,
reject verification checks,
Variable data camera challenge tests
Checkweigher challenge.
IPCs- Leak detection, Quality of packs and printed Variable data.
What are the Key documents associated with packing activities?
Packing instruction- Gives information on requirements for packing operation. Name, form, strength, batch number, expiry, Component requirements and quantities.
Packing batch sheet- Name, form, dose of product. Dates/times and people involved in packaging run. receipt to line information, Line ID, Retained components, Issues encountered, Reconciliation and approval.
What response should occur for counterfeit material identification?
WHO alerts system
EDQM falsified database
MHRA notification- detection of falsification (Yellow card system) and potentially recall material.
What packaging controls are present to combat counterfeits?
Overt features- Serialisation, ink colour, holograms, varnish patterns
Covert features- Coin reactive, web links, DNA
What stability studies are performed on new drug substances?
New drug products?
How many batches are tested?
Drug substance;
Stress testing (stability indicating methods)
Long term
Intermediate
Accelerated
Drug Product;
Photostability
Long term
Intermediate
Short term
First 3 commercial batches in final proposed packaging in MA.
What counts as a significant change when evaluating stability data?
How does this impact proposed shelf life?
5% change in assay value from initial
Degradation products exceeding spec
Failure to meet stability Spec- PH, Assay, Dissolution.
If there is significant difference noticed during accelerated study, review long term data and the ability to use statistics.
No Changes- Long term data x 2, maximum 12 months
Some changes- 1.5x long term data max 6 months
Lots of changes- no extrapolation
