Transcript Strategies to Increase the Number of Excipients Labeled USP

PQRI Workshop Discussion D
Discuss Strategies to
Increase the Number
of Excipients Labeled
USP-NF
PQRI Workshop Discussion D


Current Situation
Increasing danger that excipient
manufacturers will stop producing
excipients that meet USP-NF
standards
May result in deletion of USP-NF
monograph for such excipients
PQRI Workshop Discussion D


Current Situation
Problematic for drug product
manufacturers
Additional regulatory burden for
excipient information in regulatory
filings
• methods and acceptance criteria
• methods validation
• justification of specifications
PQRI Workshop Discussion D

Current Situation
Contrary to FDA’s cGMP Initiative to:
• strategically reduce industry’s
regulatory and paperwork concerns, and
• change the regulatory focus to
concentrate on those aspects of
manufacturing that pose the greatest
risk to product quality

such as unique attributes of an excipient
needed for manufacturing
PQRI Workshop Discussion D
Survey Results



Most (>80%) excipient
manufacturers, distributors and drug
product manufacturers make their
products for global distribution
Most (>80%) test excipients
according to USP-NF
Almost all (97%) drug product
manufacturers test excipients per
USP-NF
PQRI Workshop Discussion D

Survey Results
Most (89%) excipient manufacturers
label their excipients as compendial
grade
• survey may not be reflective of all
excipient manufacturers

Most (80%) distributors label their
excipients as compendial grade
PQRI Workshop Discussion D

Survey Results
Difficulty finding a manufacturer of at
least 1 USP-NF grade excipient?
• 40% of drug product manufacturers
• 25% of distributors
PQRI Workshop Discussion D
Survey Results

When no USP-NF grade excipient is
available, drug product
manufacturers:
•
•
•
•
•
80%
80%
90%
78%
90%
use best grade available
test excipient per USP-NF monograph
conduct audit of excipient manufacturer
do not reformulate product
do not contact FDA for direction
PQRI Workshop Discussion D

Survey Results
Reasons for not labeling excipients
as USP-NF
• 35%
• 30%
• 30%
• 30%
• 5%
low demand for USP-NF grade
GMP requirements too restrictive
internal time/resources for audits
potential to be inspected by FDA
can’t meet monograph
PQRI Workshop Discussion D
For Discussion


What are the barriers to labeling an
excipient as USP-NF grade? How can
the barriers be reduced?
What excipients are no longer
available as USP-NF grade?
PQRI Workshop Discussion D
For Discussion


What are the implications when an
excipient user moves from a compendial
grade excipient to noncompendial grade
(i.e., not designated through labeling
suffix, namely USP-NF, Ph. Eur. or JP)?
What is industry’s burden in supplying
analytical method validation data to
regulatory agency for excipients no longer
labeled USP-NF?
PQRI Workshop Discussion D
For Discussion


What test methods are used when an
excipient user must replace a
compendial grade excipient with
noncompendial grade?
What are the ongoing initiatives at
the USP to address these problems?