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Excipient
Audits
IPEA offers third party audits
to facilitate the assessment of excipient manufacturers
to appropriate current Good Manufacturing Practice
(cGMP) guidelines. Audits of excipient manufacturing
sites are performed on a worldwide basis. Audit
findings are presented in an Audit
Report which is intended to provide a basis
for confirming that the quality system used to
produce the audited excipient meets appropriate
cGMP.
Audit
Reports
This program affords excipient
purchasers the opportunity to verify supplier
excipient GMP conformance without the trouble,
time and expense of initiating an audit. Also,
this program benefits excipient suppliers who
want to demonstrate, through an Audit
Report, cGMP manufacturing conformance to
potential customers and to set themselves apart
from their competition.
Excipient
GMP Workshops
IPEA offers
workshops which train
auditors in assessing excipient manufacturer conformance
to appropriate GMP requirements. General or specific
excipient GMP workshops can be customized for your site.
Excipient
GMP Training
Needs-specific
training in excipient cGMP conformance for
facilities wishing to further enhance their quality
assurance departments.
Excipient
GMP Conformance
This program identifies and evaluates the significant audit findings in an
IPEA audit. Within this service, IPEA assists
manufacturing facilities with implementing any
necessary corrective and preventive measures that
appropriately address deficiencies in the excipient
GMP compliant quality
system.
For
details specific to your needs, please address
questions to the attention of:
Dr. Irwin Silverstein, IPEA/COO at info@ipeainc.com
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