PMID- 7964845
OWN - NLM
STAT- MEDLINE
DCOM- 19941221
LR  - 20190501
IS  - 0022-3050 (Print)
IS  - 1468-330X (Electronic)
IS  - 0022-3050 (Linking)
VI  - 57 Suppl
IP  - Suppl
DP  - 1994 Nov
TI  - Requirements for safety and quality of intravenous immunoglobulin G preparations.
PG  - 2-5
AB  - The increasing use of intravenous immunoglobulin-G preparations (IVIg) calls for 
      evaluation of the requirements for quality and freedom from infection. The WHO 
      Requirements dating from 1982 have been surpassed by the majority of IVIg 
      preparations. Three methods are used for ensuring safety from infection: the 
      restrictive choice of donor, the precise introductory screening of every 
      individual blood or plasma donation, and the additional active virus inactivation 
      procedures that surpass the virus elimination of, for example, the 
      Cohn-fractionation method. Although it is highly improbable that IVIg can 
      transfer infections, this possibility cannot be completely ruled out even when 
      all the GMP (good manufacturing practice) rules are observed most carefully. 
      Increased safety from infection would be provided if blood and plasma donations 
      were obtained nationally from unpaid voluntary donors and if an additional active 
      viral inactivation procedure was introduced.
FAU - Rutter, G H
AU  - Rutter GH
AD  - Serapharm Division of Research and Development, Munster, Germany.
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Neurol Neurosurg Psychiatry
JT  - Journal of neurology, neurosurgery, and psychiatry
JID - 2985191R
RN  - 0 (Immunoglobulin G)
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Humans
MH  - Immunoglobulin G/blood
MH  - Immunoglobulins, Intravenous/*adverse effects/*standards
MH  - Quality Control
PMC - PMC1016713
EDAT- 1994/11/01 00:00
MHDA- 1994/11/01 00:01
PMCR- 1994/11/01
CRDT- 1994/11/01 00:00
PHST- 1994/11/01 00:00 [pubmed]
PHST- 1994/11/01 00:01 [medline]
PHST- 1994/11/01 00:00 [entrez]
PHST- 1994/11/01 00:00 [pmc-release]
AID - 10.1136/jnnp.57.suppl.2 [doi]
PST - ppublish
SO  - J Neurol Neurosurg Psychiatry. 1994 Nov;57 Suppl(Suppl):2-5. doi: 
      10.1136/jnnp.57.suppl.2.