Dear Mr Rajanish,
Thanks for your response.
I partly agree with your comments however would like
question you that why should we accept all nonsense
from these agencies. its very surprising to see
various guidelines drafted by these agencies where
they copy the guidelines from another agency and they
add one new sentence in the labelling requirement.it
seems that the agencies are forcing you to design your
packaging materials especially for them .I don't know
how it helps to their country and the Patients.
Why should we accept all their requirements which is
of no use with respect to the patient safety or
Product integrity ?. In the current scenario every
one wants to get their product approval as soon as
possible and encouraging these agencies to continue
their practices.
As you said If the regulatory personnel is not going
to argue with these agencies how can they know the
practical problems involved in developing separate
packaging materials for each agency? it becomes a
burden to the development guys who is going to design
,develop,order and stock these materials and it
creates the Inventory in the ware houses.
Most surprising thing here is the many agencies which
are forcing us with their regulations does not have a
population of more than a few thousand people (which
is less than the minimum batch size of a medium scale
Pharma unit) The product requirements is very less and
based on the market competition we don't know what will
be the quantity required for the respective country
per annum.
I too agree some agencies requires the labelling in
their local languages which can not be avoided where
as the remaining agencies which accepts the english
language can be convinced for a common labelling.
with respect to inventory part it obviously creates a
huge inventory in the ware houses as one single
product is being manufactured for 30 - 40 countries
and maintaining 40 printed foils in a ware house for a
single product and the minimum order quantities of
quality printers has a lot of impact on the inventory.
If the required quantities are less the procurements
shall be done from a small printers where the quality
of material shall be compromised. if we talk about the
impact on Inventory it involves The Number of item
codes,Artworks,Print proofs,shade cards, Purchase
orders,order quantities,racks in the ware houses,
bincards,batch packing records,
documents,specifications,analysis,analysis
reports,COAs etc...which indirectly effects the cost
of the final product .
I feel that the regulatory personnel who are the
representatives for the generic companies shall take
the responsibility and convince these agencies inspite
of accepting all their requirements, and we should
work for the companies not for the agencies .
Then only the quality of the dossier filing shall
improve.
Hope you all will accept.
Regards
Chandra
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