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QP - the reprise > Packaging > Flashcards

Packaging Flashcards

1
Q

Where are the packaging requirements described in law?

A

2012/1916 schedule 24 (pointed to from part 13)

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2
Q

What needs to be on the outer box

A
  1. Name / strength, Babies, children or adults
  2. .the common name of each active substance (up to 3) and INNS.
  3. Qualitive statement on APIs and quantative per dose.
  4. form and the contents by weight, by volume or by number of doses of the product.
  5. A list of excipients - all for steriles and eyes but only those with a physical action for other does forms
  6. method of administration of the product and if necessary the route of administration.
  7. space for the prescription label.
  8. A warning that the product must be stored out of the reach and sight of children.
  9. Any other warnings applicable to the product.
  10. batch number / expiry date.
  11. storage conditions of the product.
  12. disposal instructions.
  13. MA holder.
  14. PL number.
  15. Instructions for use (OTC only)
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3
Q

What information do blisters need on them?

A

a) Name of the API and strength
b) Name of the MA holder
c) Expiry date
d) Batch number

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4
Q

What label content do small immediate containers need

A

a) API name and strength
b) Method of administration
c) Expiry date
d) Batch number
e) Contents by weight, volume or unit

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5
Q

What are the general requirements around leaflets?

A

Leaflets are mandatory unless all the info is directly on outer or immediate packaging.

They must be clear (and developed with target patient group).

They must be available in braille upon request.

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6
Q

What info must the leaflet contain?

A

a) Name, strength and pharmaceutical form type of activity

b) Therapeutic indications

c) List of info to know before taking the product
i. Contra-indications
ii. Appropriate precautions
iii. Interactions (other medicines, alcohol, food etc)
iv. Special warnings inc do not drive, breastfeeding, elderly, kiddies, excipient warnings

d) Instructions for use –
i. The dose
ii. Method / route of administration
iii. Frequency of dose
iv. Duration (where it should be limited)
v. Action to be taken in case of overdose
vi. What to do when miss a dose or two
vii. Withdrawal effects (if necessary
viii. Recommendation to consult a Dr for clarification on use

e) Adverse reactions which may occur and what to do about it

f) Reference to the expiry date and –
i. Don’t use it after that date
ii. Storage precautions (if appropriate)
iii. Warning re visible signs of deterioration (if appropriate)
iv. Qualitive composition of everything and quantitvie of API
v. Pharmaceutical form, content in weight, volume or units of dosage for all presentations
vi. MA holder and address
vii. Name and address of manufacturer.

g) List of names allowed in different member states

h) Date the leaflet text was revised.

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7
Q

What must the leaflet also contain if there’s a little black triangle?

A

“This product is subject to additional monitoring” for products subject to additional pharmacovigilance monitoring which is indicated by a black triangle.

Could be a new medicine, a new indication or route of administration.

Encourages patients to report ADRs via Yellow Card Scheme

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8
Q

What are the PMQC tests for bottles?

A

Visual appearance

Dims – height, thickness, diameter, weight

Performance – MVTR, light transmission, extractables, closure compatibility

Materials – IR

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9
Q

What are the PMQC tests for plastic caps?

A

Visual Appearance

Dims

Performance – heat sealing with bottles, MVTR

Materials - IR

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10
Q

What are the PMQC tests for foils / laminates

A

Artwork accuracy

Dims – thickness, width, registration marks

Performance – pharma code, ink adhesion

Materials - IR

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11
Q

When must you use child resistant packaging

A

If it contains
Asprin
Paracetamol
x>24 mg Elemental Iron

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12
Q

When don’t you have to use child resistant packaging

A

If your product is effervescent
If your product is packed in single dose units

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13
Q

What types of glass are there?

A
  • Type 1 – borosilicate glass
  • Type 2 – soda lime glass
  • Type 3 – soda lime glass with moderate hydrolytic resistance, oral liquid products
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14
Q

When do you use type 1 glass?

A

When need good chemical resistance,
usually for sterile, pre-fill syringes, tubular glass vials
BOROSILICATE

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15
Q

Why do you use type 2 glass?

A

It has a treated surface to give high hydrolytic resistance, moulded glass infusion bottle

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16
Q

Why do you use type 3 glass?

A
  • It has moderate hydrolytic resistance,
  • Used with oral liquid products
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17
Q

What are the critical devices on a blistering line

A
  1. Splice detection
  2. Forming temperatures and pressures
  3. Line speeds
  4. Vision systems
  5. Barcode checks
  6. Foil registration
  7. Pinhole detection
  8. Overprint OCR
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18
Q

What are the critical devices on a bottling line

A

Counts
Speeds
Torque settings
Cocked cap sensor
Seal presence sensor
Induction sealer height and power

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19
Q

What are the supplier controls for artwork

A

Only approved artwork is made

Obsolete artwork / masters destroyed

Stock identity controlled

Stock segregation

Supply chain controls (distribution chain control and QC testing before use)

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20
Q

What are the packaging controls on site which prevent mishap at goods receipt?

A

Good Receipt –
* Incoming inspection
* Quarantine
* Sample plans
* Release to specification

Packing Line –
* Line segregation / line clearance
* Systems for issuing and returning components
* Confirmation against BOM
* 100% verified and reconciled
* Process for component returns
* Critical devices and IPC*

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21
Q

What are the packaging controls on site which prevent mishap on line?

A

Packing Line –
* Line segregation / line clearance
* Systems for issuig and returning components
* Confirmation against BOM
* 100% verified and reconciled
* Process for component returns
* Critical devices and IPC
* All components left on line at end destroyed.

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22
Q

What should line clearance look like?

A
  • Documented procedure
  • Checklists
  • Zoned off areas
  • Defined process if find a rogue
  • Isolate line during clearance
  • Live line clearance and experts
  • Use of measles charts
  • Include electronic data
23
Q

What are the common causes of packaging mix ups?

A
  • Use of incorrect materials
  • Incorrect line clearance
  • Unclear line / equipment status
  • Failure of checking equipment
  • Line setup incorrect
  • Control of samples / IPCs
  • Inadequate reconciliation / stock control.
24
Q

What can and cannot be returned to packing line

A

NEVER return samples to line.

Ejects to be returned by competent people after formal (recorded) inspection.

25
Q

What to do with unused packaging components at the end of the batch?

A
  • Unused batch coded materials to be destroyed and destruction recorded.
  • Returning un-coded materials to warehouse to be controlled by written procedure
26
Q

What are packing IPC examples?

A

appearance, complete packs, artwork and printing

27
Q

What online packaging controls are there?

A
  1. Line clearance in place and completed
  2. Check components against BOM
  3. Place on line
  4. Challenges/critical devices
    a. Balance/check weigher
    b. Pin-hole
    c. Splice sensor
    d. Cameras
    e. Barcode sensor
    f. Overprint sensor
    g. Presence of component
    h. Reject mechanism – missing component
  5. Start-up check – first pack check for bx variable data, appearance, all components present
  6. IPC checks - bx variable data, appearance, all components present, seal integrity, child resistance
  7. EOB – last pack check, retention and ref samples
  8. Line clearance, reconciliation, components returned/destroyed
28
Q

What is a P1 artwork change

A

first approval of mock-ups following a granting of an MA where only text-only versions were submitted and approved as part of the MA applications.

29
Q

What is a P2 artwork change

A

Changes to patient information leaflets which include significant changes to content and/or design and layout.
Changes big enough that user testing or bridging data showing patients can find the info / data they need.

30
Q

What is a P3 artwork change

A

Changes to pack design must always be submitted for full assessment. Changes include either layout of the information or changes to graphics on the pack, or both

31
Q

What is a P4 artwork change

A

1) When MHRA tells you that a change is needed such as:
a) approval of artwork for a new own-label supplier not previously known to MHRA

b) approval of artwork following a product name change where the changes proposed to the pack are considered to go beyond being relevant to the changes to the summary of product characteristics (SPC) being applied for

c) introduction of new safety information following consideration by an expert advisory committee

d) amendment of artwork following a complaint relating to patient safety

32
Q

Where in the regulation is the requirement to submit mock ups to MHRA

A

According to Regulation 267 of the Human Medicines Regulations (HMR) 2012 as amended, the mock-ups of labelling components (e.g. labels and cartons) are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA):

  • as part of the dossier in any application for a new product
  • when there is a change to the information in the SmPC which impacts the labelling components
  • or when a stand-alone change(s) to the labelling components is proposed
33
Q

What is checked at end of packaging run

A

retention sample with BD,
check bx variable data,
presence of components,
tamper evidence,
colour,
presentation

34
Q

What are the critical, major, minor %s for packaging?

A

0, 1%, 2.5 %

35
Q

What are the critical AQLs for cartons?

A

-Rogue
-Incorrect/ illegible print
-Incorrect colour
-Contamination by extraneous material

36
Q

What are the major AQLs for cartons?

A

-Insufficient glue
-Excess glue, causing surfaces to adhere
-Partially missing print
-Dot braille not formed correctly

37
Q

What are the minor AQLs for cartons?

A

Minor appearance defects, which detract from the normal standards of
commercial quality but do not affect the functional performance of the cartons.

38
Q

What are the critical AQLs for labels?

A

-Rogue label on a reel
-Illegible and/or missing print.
-Incorrect label orientation and reel geometry.
-Print detail, including varnish, not as specified on the artwork

39
Q

What are the major AQLs for labels?

A

-Poor print quality.
-Missing labels.
-Loosely wound reels.
-Damaged reels/backing paper.
-Any defect likely to affect functional performance.
Single Sampling, Special Inspection Level S4

40
Q

What are the minor AQLs for labels?

A

Appearance defects which detract from the normal standards of commercial quality, but do not affect functional performance or pack quality.

41
Q

What are the critical AQLs for leaflets?

A

-Rogue components.
-Illegible and/or partially missing print.
- Basic colour, print or text not as specified on artwork.
-Incorrect material of construction (paper type)
-Incorrectly folded.
-Incorrect or Unreadable datamatrix code or pharmacode.

42
Q

What are the major AQLs for leaflets?

A

-Torn or badly cut.
- Badly smudged, but legible print.
-Any other defect likely to affect functional performance.

Single Sampling, Special Inspection Level S4

43
Q

What are the minor AQLs for leaflets?

A

-Poor but legible print.
- Badly aligned print.
-Appearance defects which detract from the normal standards of commercial
quality, but do not affect functional performance or pack quality.

44
Q

What are the critical AQLs for foils?

A

-incorrect colour or print compared to artwork
-Illegible and / or partially missing print including bar codes and registration marks
-Visible contamination by biological foreign matter (e.g. hair or insect) or adverse/hazardous foreign matter.
-Damaged or malformed material.
-Rogue reel(s).
-Delamination.
-Splits or holes through all layers of the laminate.

45
Q

What are the major AQLs for foils?

A

-Visible contaminants
-Poor appearance
- scuffing, scratch marks or creases.
-Surface contamination - Outside surface contaminated preventing or reducing adhesion of on line printing
-Damaged or malformed reels
-Badly or loosely wound reels (e.g. reel tension) likely to affect machine performance.
-Incorrect colour saturation.

46
Q

What are the minor AQLs for foils?

A

-poor but legible print

-Minor appearance defects which detract from the normal standards of commercial quality, but do not affect functional performance or pack

47
Q

What are the possible additional tests for cartons?

A

-Carton erection test
-Third party security check (test each die station)
-Dimension check (test each die station)
Also think about: braille on cartons

48
Q

What are the possible additional tests for leaflets?

A

Also think about:
Print quality using light fast inks, rub resistant, colours to agreed colour standard, as stated on the artwork.

  • The leaflets cut with all angles being 90°.

-Paper type is specified: “Sheeted or reeled, wood free, neutral sized, acid free, machine finished white paper for production of finished printed leaflets”.

Functional dimension check:
-Leaflet Length & width (Finished / Folded Size/ unfolded)
- position of crease line & perforation
-One leaflet per batch is check Pharma Code position.
Grain direction and weight.

49
Q

What are the possible additional tests for labels?

A

Also think about:
Ink fastness, tension, number of splices on the reel, number of labels within tolerance.

50
Q

What are the possible additional tests for foils?

A

Supplier should have camera to monitor for pin holes & splits & do own dye testing on each batch

Inspect Foil width to +/-1mm and position of registration mark

Performance tests:
Foil weight
Sealing layer- check spectrum of sealant by IR

51
Q

What are the critical devices for a blister line?

A

splice detection,
forming temps,
line speed,
vision systems,
foil registration,
pinhole detection,
overprint OCR

52
Q

What are the critical devices for a bottle line?

A

counts,
speeds,
torque setting,
cocked cap sensor,
induction seal power/height

53
Q

What are the critical devices on a Cartonner/labeller/leafletter –

A

barcodes,
overprint OCR,
line speed

QP - the reprise (15 decks)

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