Pharmaceutical Packaging Flashcards
Define “substandard medicine”
Authorised product that fails to meet quality standard or specification
Define “falsified medicine”
Product that has deliberately/ fraudulently misrepresented their identity or source.
May contain:
- no API
- incorrect amount of API
- cornstarch/ chalk
- often produced in poor conditions
Provide key areas of falsified medicines directive
2011/62/EU - FMD
R 2016/161
All prescription medicines have safety features making it possible to:
Verify authenticity & identify individual packs and see if any tampering
- safety features (including unique identifier)
- a common EU logo to identify legal online pharmacies
- tougher rules on import of API
- improved record keeping for wholesale
Operational duty of QP
Describe some anti-counterfeit technologies
- inks (respond to certain features)
- substrates
- chemical additives (taggents)
- printing techniques
- physical features (TEL)
Describe some overt features
- holograms
- ink colour change at angles
- component corner radius
- varnish pattern with intentional error
- dot varnish void
- temperature sensitive ink
Describe some covert features
- microdots
- coin reactive
- scrambled ink
- hidden ink
- taggents
What are the indicators of lack of stability
- loss of efficacy
- loss of content uniformity
- increase in concentration
- microbial contamination
- production of impurities
What is the purpose of a stability study
To measure how the quality of a drug varies with time under different storage conditions
Where would you find information about stability within CTD?
Module 3
3.2.S.7 - drug substance
3.2.P.8 - drug product
Name 3 stability tests
- Stress test
- establish the degradation pathways - Accelerated test
- increase the rate of degradation or physical change - Long term (real time) test
- evaluation of real time physical, chemical, biological & micro characteristics
When is stability testing needed
- evaluation of the drug substance
- pilot scale manufacture for CT
- production scale up
- quality monitoring
- after any significant variation
ICH guidelines - first 3 production batches lost approval
Describe bracketing approach
When you have several different pack sizes and you extrapolate results between them.
Describe matrixing approach
Reducing the number and extent to replicate testing.
Assumes the stability of each subset of sample tested represents the stability of all samples at a given time point.
Shelf life guidelines
ICH Q1 E
With statistics: extrapolate shelf life by 1.5 x to max of 6 months
Without statistics: max 3 month shelf life extension
Describe pros & cons of glass as a packaging material
Pros
Clear
Strong
Stable
Impermeable
Acid resistant
Hygienic
Heat sterilise
Cheap
Cons
Breaks
Sensitive to alkalis
Heavy
Limited colours
Name some common primary packaging materials
Glass
Plastic
Rubber
Aluminium (foil)
Container closure must provide appropriate levels of…
- protection
- compatibility (that CC will not cause unacceptable changes in quality)
- safety (from leaching)
- performance (meets the functionality)
What is an associated component
Not in direct contact with the dosage form but intended to deliver the dose (measuring cup, syringe etc)
Describe approval process for artwork
Artwork prep
Transfer to supplier
Generate proof
Customer approval
Plate preparation
Printing
Supply of component
Describe tests for packaging components
Visual appearance
Identity
Microbial testing
Physical dimensions
Proofing
Key elements of URS
User Requirement Specification
Intended use
Size/ location
Safety considerations
Maintenance
Supplier packaging
Key elements of pre delivery qualification
FATs - Factory Acceptance Testing
- Operational assessment of equipment against spec at the supplier site
- protocol & report
- must comply with design spec
Key elements of IQ
Installation qualification
- confirmation it complies with design spec
- satisfactorily installed
- system checks
- compilation of data
- calibration
- PPM
Key elements of OQ
Operational Qualification
- confirmation of correct functions
Functionality of:
Safety systems, alarms, feedback loops
Key element of PQ
Performance Qualification
-Is the output as expected
- check it can consistently perform
Which medicines are exempt from FMD?
- homeopathic products
- radio pharmaceutical
- medicinal gases
- ATMPs
Describe features of a unique identifier
2D barcode containing:
- product code
- serial number
- national reimbursement
- batch number & expiry
Printed on pack, data uploaded to EMVS by MAH & transferred to national database
What are the GMP requirements of a batch record
- Name of product
- description of dosage form
- pack size
- details of IPC & sampling
- formally reviewed & approved
- records of what was done
What is a retention sample & purpose
A sample of a fully packaged unit
Stored for ID purposes
Retained for at least 1 Year post expiry
List different temperatures
- Ambient (25-30oC)
- Cold chain (2-8oC)
- frozen (0- -20oC)
- deep freeze (-20 - -150oC)
- cryogenic (< -150oC)
What are WDA holder responsibilities
Any wholesaler must have a WDA
responsible for implementing QMS
Have RP
What is RP
Responsible Person
- Named on WDA & responsible for QMS at wholesaler/ distributor
- coordinates recalls
