Linked Life Data

9413684

Source:http://linkedlifedata.com/resource/pubmed/id/9413684

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1998-2-12
pubmed:abstractText
Raw materials (RM) testing and control strategy form a major part of the foundation of a well-characterized protein (WCP) or biopharmaceutical. Raw materials may be present in the final vial as excipients or may have product contact earlier in processing. Manufacturers of WCPs should use a scientific approach to set acceptance criteria and test methods for bulk raw materials which are not present in dosage forms in substantial amounts. These methods and standards should enable the procurement of specified RMs which enable the reliable preparation of a product which consistently meets its quality attributes. Manufacturers of WCPs must use available pharmacopoeial standards for excipients and bulk process RMs which cannot be substantially removed during purification or other processing steps. Manufacturers should support efforts to harmonize pharmacopoeial standards for excipients.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0301-5149
pubmed:author
pubmed:issnType
Print
pubmed:volume
91
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
65-72
pubmed:dateRevised
2005-11-16
pubmed:meshHeading
pubmed:year
1997
pubmed:articleTitle
Raw material considerations.
pubmed:affiliation
SmithKline Beecham Pharmaceuticals, King of Prussia, PA, USA.
pubmed:publicationType
Journal Article, Review