cGMP/GLP Research Committee
cGMP/GLP compliance is vital to the success of the biotechnology and
biopharmaceutical industries and their respective contract suppliers.
Biomolecular core facilities that have not yet adopted these regulations
may respond, "Important, okay, but what do these compliance acronyms mean?"
cGMP is current Good Manufacturing Practices: the part of quality assurance
aimed at ensuring that products are consistently manufactured to a quality
appropriate for their intended use. These evolving regulations are outlined
in 21C.F.R (Code of Federal Regulations) 210 and 211, amended in the 600
series of biologics. GLP is Good Laboratory Practices: regulations issued
by the FDA describing practices for conducting non-clinical laboratory
studies. The GLP standards are listed in GLP 21C.F.R.58. An excellent
source for cGMP/GLP compliance information is BioPharm, a journal that
describes the technology and business of biopharmaceuticals. This journal
reviews not only FDA compliance regulations but also test method and
process validation strategies from field experts.
For this year, this committee has planned two educational activities: the
committee will distribute a membership survey on cGMP/GLP issues, and it
will organize a workshop for the ABRF Meeting in Boston. The workshop will
further define relevant terms and address compliance requirements for core
facilities that have an interest in becoming contract suppliers for
pharmaceutical and biotechnology industries as well as core facilities that
want to maintain a level of quality for their in-house customers. The
format of the workshop, entitled "Quality Issues in Analytical Facilities",
consists of three 20 minute presentations by guest speakers who will
highlight quality strategies in academic and industrial core facilities.
The presentations will then be followed by an open and participatory
question and answer period.
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Created: 27th July 1995
Last modified: 27th July 1995