1. Introduction: The leaflets are made from maplitho paper,
tissues paper, Bible paper, opaque paper. The leaflets are printed by web
offset printing process. After printing process it goes in folding department
for folding in its varies size. They are used for pack insert in carton. Varies
colours of paper or ink can be used for identification. Patient information leaflet for human medicines
is a document provided along with medicine or over-the counter medication to provide
additional information about that drug.
Patient information leaflets are leaflets
containing specific information about medical conditions, doses, side effects that
packed with medicines to give the user information about the product.
2. General information: Paper is a thin material produced by pressing
together moist fibers
of cellulose
pulp derived from wood,
rags
or grasses,
and drying them into flexible sheets. It is a versatile material with many
uses, including writing,
printing,
packaging .The Grammage of paper is 50 GSM to 80 GSM used for leaflet. Package
inserts follow a standard format for every medication and include the same
types of information.
· Clinical pharmacology
· Indications and usage
· Contraindications
· Warnings
· Precautions
· Adverse reactions
· Drug abuse and dependence
· Over dosage
· Dosage and administration
3. Test parameter:
· Text matter: Compare text matter of sample with approved artwork.
Acceptance criteria: Text matter should be as per approved
artwork
· Colour: Check the colour of sample with approved shade card. The
sample colour should match with approved shade card.
Acceptance criteria: Shade should be as per approved shade card.
· Dimension:
Acceptance criteria:
Tolerance for Length :
± 2 mm
Tolerance for Height
: ± 2 mm
· Grammage:
Cut the sample in 5cm x 5cm piece, weigh it and calculate the
Grammage with following formula
Weight of 5 cm x 5 cm piece in gm
Grammage = ----------------------------------------------
x 10000
5 cm x 5 cm
Acceptance
criteria:
Grammage: Not less than 50 gsm
