Pharmaceutical Packaging

Question 1

What are the common plastics used in pharmaceutical packaging?

Answer 1

HDPE and LDPE - High / Low density polyethylene

PP - polypropylene

PVC - poly vinyl chloride

PET - poly ethylene terephthalate

Question 2

What information would be on a blister pack?

Answer 2

Name of Product
Name of MAH
Batch Number
Expiry

Question 3

What information would be on a PIL?

Answer 3

Article 59 2001/83/EC

Name/ Strength / Dose
Adults / Children
Therapeutic Indications
Contra- indications
Precautions in Use
Interactions / Special Warnings
Route of Administration
Duration of treatment
Actions in event of overdose / missed dose
Withdrawal effects
Adverse Reactions
Storage
Composition
Name / Address of MAH and Manufacturer
Where product is authorised

Question 4

What are the common materials for blisters, sachets and tubes?

Answer 4

Blister - PVC, Aclar, Aluminium

Sachet - Paper or Paper/Foil

Tube - Aluminium, Aluminium/PVC or PP

Question 5

What are the types of Glass and what products are they used for?

Answer 5

Type 1 - Borosilicate- sterile
Type 2 - Soda-lime-silica - highly hydrolytic resistant- acidic or neutral aqueous preparations
Type 3 - Soda-lime-silica moderate hydrolytic resistance/ non- aqueous preparations (tablets or syrups)

Question 6

What should be on the outer packs of a medicinal product?

Answer 6

Article 54 2001/83/EC

Name
Strength
Dosage Form
Intended for Adult/Child
Active Substance
Number of doses
Excipient List
Method of administration
Prescribed dose
Special warnings
Expiry
Batch Number
Storage conditions
Name / Address of MAH
MA number
Safety Features

Question 7

What are the timelines for updates to printed packaging?

Answer 7

6 months from date of approval

Urgent Safety Update - 3 months from date of approval

Critical Safety Update - use DMRC alert process

Question 8

Talk high level what do you need to know about medical devices?

Answer 8

EU - 2017 / 745
UK - 2002 / 618

Medical devices are used in combination with medicinal products or alone for specific medical purposes

Medical devices have a design history file that is started during development and is kept up to date throughout the device lifecycle

A device responsible person is accountable for the content of this file.