Special Provisions Relating to Biological and other Special Products
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These products cannot be sold unless they have been sealed in previously sterilized containers made up of glass or other suitable materials approved by the Licensing Authority.
Special Provisions Relating to Biological and other Special Products
These
products cannot be sold unless they have been sealed in previously sterilized
containers made up of glass or other suitable materials approved by the
Licensing Authority. This is not necessary if the substance is to be terminally
sterilized.
In
multiple dose containers, sufficient proportion of antiseptic! preservative is
to be added. This is not applicable to penicillin suspensions. Test for
sterility for surgical ligatures and sutures should be carried out as per
Schedule F.
Special provisions
of Biological products can be covered under the following.
1. Test for sterility
2. Test for freedom from abnormal toxicity
3. Test for pyrogens
4. Approval oftesting institutions for biological products.
Test
for sterility, abnormal toxicity and pyrogens are carried out as per procedures
described in Indian Pharmacopoeia.
Following biological
and other products shall be tested for freedom from living aerobic or anaerobic
micro-organisms.
(a) Sera and solution of sera proteins
(b) Bacterial vaccines and antirabis vaccine
(c) Preparation of posterior pituitary lobe
(d) Toxins,
antigens, and their mixtures and immunisation or diagnostic products
(e) Preparation of insulin
(f) Any other parenteral preparation
(g) Any preparation
from culture of pathogenic organism to be administered orally which must be
steriled.
Procedure for
sterility test
(some requirements):-
(i) Preparation: Not less than 0.1 % volume of batch
for a batch which is less than 10 litres; 10ml if, volume is more than 10
litres.
(ii) Containers: Not less than 1% of
total number of containers if the batch is of more than 1000 containers; and a
minimum of 10 container, if the total number is less than 100.
(iii) Medium for aerobic micro-organism: It consists of
either meet extract with addition of 1% peptone or equivalent medium.
(iv) Medium for
anaerobic micro-organism: It
consists of nutrient broth similar to use in testing aerobic micro-organism
with addition of heat coagulated musle, sufficient to occupy a depth of not
less than I cm at the bottom of
the tube.
For
manufacturing of Schedules C, C (l) and X, the particulars of production,
quantity of Schedule X drugs used for manufacturing and quantity of
manufactured drugs are required to be maintained by the licensee.
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