Drug-product manufacturers qualify new sources of excipients by vendor audits and complete testing according to the compendial
monograph. According to the survey, 40% of drug-product manufacturers had difficulty finding a manufacturer of at least one
USP–NF grade excipient (see Figure 4). In such a situation, they would use the best grade available, test the excipient according
to the compendial monograph, and conduct an audit of the excipient manufacturer. Approximately 75% of drug-product manufacturers
indicated they test and perform site audits to confirm compliance (for "a few" to "all" excipients) with compendial-grade
standards. In 80% of the cases, respondents used validated test procedures to confirm the compliance of noncompendial grade
excipients with compendial grade standards, or confirm that products conforming with one compendial grade also met standards
from other compendia.
Figure 7: Respondents reporting familiarity with requirements of Food Drug and Cosmetic Act and 21 CFR Part 211.84.
Only a minority of responding excipient manufacturers and distributors cited specific reasons for not labeling their products
as USP–NF compendial grade. Approximately one-third cited low demand for compendial grade products; just under 30% cited restrictive
GMP requirements, the prospect of FDA inspection, or the time and resources needed to perform required audits. Only a handful
expressed doubts about being able to meet compendial monograph requirements (see Figure 5). Nearly 80% of excipient manufacturers
and drug-product manufacturers, and 60% of distributors, have been inspected or visited by FDA for either drug excipient or
food use (see Figure 6).
Figure 8: Respondents testing excipients by Ph.Eur. or JP methods instead of USP–NF.
Among drug-product manufacturers, 89% have five or more excipients in reduced-testing programs, and do not perform complete
monograph testing after vendor qualification and receipt of C of A.
Excipient manufacturers, distributors, and drug-product manufacturers all responded that they feel adequately familiar with
the applicable FDA and compendial requirements and recommendations related to testing of excipients used in a drug product
(see Figure 7).
Figure 9: Respondents applying harmonized monographs and general chapters across all sites.
Among manufacturers, distributors, and users of USP–NF excipients, 70% or more perform additional functionality or processability testing that is not part of any USP–NF,
European Pharmacopoeia (Ph.Eur.), or Japanese Pharmacopoeia (JP) compendial monograph. Of these, 87% perform the tests because of processing concerns. Most additional testing was performed
for solid oral dosage forms (87%), and 24% of drug-product manufacturers have products for which excipient variability is
a problem in spite of such extra-compendial testing.