Page 13 - FAR 222 Laboratory Manual V2 2019

FAR 222 Dosage Form II Laboratory Manual

Table 5 Special Considerations for Expiry Date for Sterile Products

Sterile
products Sterilisation method Expiry date**
Methods A and C by BPC 1973 Four weeks after first opening of the
(heat sterilisation) products
Eye drops
Method B by BPC 1973 (non- Two weeks after the date of
heat sterilisation*) sterilisation (manufacture)
One week after first opening of the
Heat sterilisation
Multi-dose products
injection Two weeks after the date of
Non-heat sterilisation*
sterilisation (manufacture)
*refers to aseptic filtration; **unless otherwise specified

GENERAL LABEL FOR INJECTIONS
This applies to the label on the CONTAINER of any injection having a capacity of more than
10 mL and to the package of ANY injection, e.g. ampoule box.

The label on the package of any medicinal product and the label on any container having a
capacity of more than 10 mL must bear the following details:

a) name of product
b) description of pharmaceutical form - can be omitted on container if container is
enclosed in a package
c) strength - a weight or volume of active ingredient per unit dose
d) official name - if applicable
e) international non-proprietary name - if applicable
f) quantity of product
g) directions for use - if appropriate. Can be omitted from container and package if a
leaflet is contained in package and container and package show that such particulars
are also included in a leaflet
h) contra-indications - if any
i) special handling and storage conditions
j) date of sterilisation
k) expiry date
l) batch reference/number (BN)
m) manufacturer's licence number - if applicable
n) any other details required by licence
o) name of patient - if applicable
p) date of dispensing- if applicable
q) ‘Keep out of reach of children’
r) any warnings or other special requirements

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