[e-farmacos] Particulas extranhas y fabricacion ARV (cont.)

["Perez, Carmen" <carmen_perez@madrid.msf.org>]

E-farmacos: Particulas extranhas y fabricacion ARV (cont.)
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Querida Susana,

A continuacion compartimos la respuesta a tus preguntas facilitada por
un experto europeo en fabricacion de medicamentos. Esperemos aun sean
utiles.

Carmen Perez Casas
Coordinadora Farmaceutica
Campanha de Acceso a Medicamentos Esenciales
Medicos Sin Fronteras 

Point 1. Particulate contamination evaluation in parenteral preparations
Methods  and  acceptable  limits  are described in the following
compendial monographs.  It  should  be  noted that limits are related to
the amount of volume  of  the  units  :  large  volume parenterals [LVP]
or small volume parenterals   [SVP].   According  to Pharmacopeia, 
LVPs   are  injections containing more than  100ml).

 References :
USP 24 <788>  pages 1971-1977: Particulate matter in injections 
EU   Pharmacopoeia   4th  edition  (2.9.19)  pages 219-222 

Particulate contamination : sub-visible particles 
The  number  of  samples required are also described but it is important
to define  a  sampling  plan  to provide a statistically sound
assessment ( so sample  shall  be  taken  regarding steps  of the
filling process with the greatest risk of contamination).

Point 2. Areas Classification for antiretrovirals (ARV) manufacturing
ARV  manufacturing  operations  shall  be performed in clean areas built
in Compliance  with  relevant  pharmaceutical  GMP (General provisions
can be found   in   Chapter  3  EU-GMP  or Chapter  11 WHO-GMP,  and 
particular requirements  are  stated  in    EU  items 5.18  + 5.19 or
WHO items 15.11 + 15.12). 

These  operations  shall  be  carried  out  in  such manner to prevent
any cross-contamination  with  other  drug products.  Most of ARV
products are formulated  in solid oral dosage forms. Thus, the main risk
is the airborne contamination.  So  air handling  systems with efficient
air filtering are demanded ( minimum     filter(s) grade EU 9).



[NOTA: Mensaje sin acentos ni caracteres especiales.]
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