Introduction
Modern medicine depends on a guarantee we often take for granted:
that the drugs we swallow, apply, or inject work as intended. By law, it
is drug manufacturers who bear the primary responsibility for making
sure each product meets quality standards. The role of the Food and Drug
Administration (FDA) is to ensure manufacturers comply with these
requirements, but as supply chains expand across the globe, this role
has become harder to carry out.
To ensure consistent drug quality, FDA relies on
a combination of prescriptive regulatory requirements, facility
inspections, and various compliance tools. FDA requires manufacturers to
have strong quality systems that follow Current Good Manufacturing Practices (CGMP),
including oversight of every production step, checking samples during
production, and keeping thorough records. FDA investigators then verify
compliance with standards through both scheduled and unannounced inspections,
during which they review everything from personnel training and
equipment maintenance to contamination control and recordkeeping. When
serious violations are uncovered, FDA can act through warning letters, drug recalls, import refusals, import alerts, and injunctions.
But the FDA oversight system is imperfect. FDA struggles with
persistent staffing shortages and inspection backlogs, especially for
foreign facilities in countries like India and China. Many inspections
abroad are still announced in advance, which weakens detection of compliance issues. Driven by economic forces, pharmaceutical manufacturers of low-cost generics often have weak quality management systems and quality assurance units that lack the authority and resources to enforce CGMP compliance effectively. FDA’s “too important to fail problem”—where FDA will allow noncompliant facilities to continue shipping medically necessary drugs if there is shortage risk—only reinforces those weaknesses.
Proposals to address these shortcomings primarily focus on supporting FDA through expanding unannounced inspections, increasing inspection frequency, improving policies to ensure inspector independence, addressing inspection workforce and backlog challenges, and exploring alternative monitoring tools, such as remote access to documents, information from inspections conducted by foreign regulators not part of mutual recognition agreements, or third-party audits.
In this paper, I propose an alternative but complementary path to
enhance U.S. drug quality assurance by requiring every importer to
designate a qualified individual—located in the U.S.—who certifies that
each batch meets Good Manufacturing Practices (GMP) standards after
assessing the firm’s compliance, including through additional testing of
product. This framework—already established in Europe for drugs and to
some extent in the U.S. for certain food imports—raises accountability
and increases oversight by adding a second, importer-level layer of
verification beyond the manufacturer.
To motivate the proposal, this paper first examines how the U.S. and
European systems differ in their approach to manufacturing quality
compliance, including through batch release procedures, finished product
testing, and facility inspections. It then reviews FDA’s Foreign
Supplier Verification Program, authorized under the Food Safety
Modernization Act of 2011. Next, the paper explores the benefits of
adapting the “Qualified Person” and import testing systems within the
U.S. drug quality oversight system—not as a replacement, but to
strengthen the existing regulatory framework. Finally, the paper
discusses various considerations for implementing these changes
Approach to accountability
International GMP standards
require that drug manufacturers conduct a thorough review of all
production, packaging, and testing records to confirm compliance with
documented procedures and quality standards, with formal approval
carried out by qualified personnel before any batch is released for
distribution.
To comply with GMP standards, both FDA and EU legislation mandate
that manufacturers maintain an independent department—called the ‘Quality Unit’ under FDA regulations and ‘Quality Control’ (QC) in the EU—responsible
for approving or rejecting materials and products, reviewing production
and quality records, investigating discrepancies, ensuring controls and
procedures are followed, and maintaining the overall pharmaceutical
quality system.
But the degree and nature of accountability differ substantially between the FDA and EU models.
In the EU system, the importer must designate a Qualified Person (QP)—a
specific individual who holds personal responsibility to certify that
each batch released for sale meets GMPs, the product’s marketing
authorization (the EU equivalent of FDA drug approval), and all
applicable EU laws. However, a QP is not simply appointed by the
importer; the individual must have specialized academic degrees,
relevant industry experience, and must be formally recognized and
approved by the relevant national regulatory agency before they may take
on the role. The QP’s professional qualifications, certification
requirements, and responsibilities—including the non-delegable duty for
batch certification—are fully detailed in EU law and accompanying
guidance, particularly EudraLex Volume 4, Annex 16.
Because the QP operates in addition to, not instead of, the
manufacturer’s QC, release of an imported batch involves two steps.
First, the exporting manufacturer’s internal QC department authorizes
shipping from the foreign production site to the EU importer. Second,
the EU-based QP ensures that the batch is re-tested in the EU and then
certifies that the batch was manufactured in accordance with EU GMP and
in accordance with the EU marketing authorization. Only following the QP
certification may the batch be released into distribution.
To fulfill their responsibilities, QPs review quality documentation
provided by the manufacturer’s quality control or third-party
laboratories. QPs have limited discretion to certify batches exhibiting
minor deviations—those deviations that do not affect product quality,
safety, or efficacy—but only after conducting a thorough, documented
risk assessment. Batches with major deviations or out-of-specification
results that could potentially impact product quality or patient safety
must not be certified.
QPs can delegate to trained personnel some of the checks necessary
for the review, but they cannot delegate their sign-off responsibility.
QPs may face personal liability if they negligently certify defective products that cause harm. QPs must be EU residents, putting their QP accountability within the EU importer’s jurisdiction.
QPs may join, or in some cases are required to join, national or
international professional associations dedicated to supporting QPs.
These organizations, such as the European Qualified Person Association
(EQPA), provide platforms for ongoing education, facilitate the exchange
of best practices, and promote harmonization of standards across the
region. Membership can offer access to policy updates, professional
discussion forums, and regular meetings or seminars to address emerging
challenges in pharmaceutical quality assurance. Depending on the
country, association membership may be a formal prerequisite for QP
registration or may simply be encouraged as a valuable resource for
professional development and networking within the highly regulated
environment of drug manufacturing oversight.
Approach to testing
Both the U.S. and EU regulatory systems require that
drug manufacturers comply with GMPs, which in turn means that
manufacturers must perform in-process and final product sampling using
official pharmacopeial methods—the US Pharmacopeia (USP) in the United
States and the European Pharmacopoeia in the EU. In both jurisdictions,
manufacturers can do their testing in-house or can contract it out to
analytical labs. Contract laboratories are considered part of the
manufacturing process and must be registered with regulators and subject to GMP inspections.
However, the U.S. and European regulations differ in how they
approach product testing beyond the GMP-mandated analyses performed by
or on behalf of manufacturers.
In the United States, FDA does not mandate testing beyond what is required for the manufacturers’ Quality Units at the site of manufacture as part of standard CGMP procedures, It may, however, require additional testing as part of enforcement actions, such as a consent decree or a warning letter. In such cases,
FDA may require the manufacturer to utilize an external laboratory to
perform supplemental CGMP-compliant analyses. The FDA also operates its own drug testing laboratories; however, these activities are limited in scope and volume, focusing primarily on risk-based sampling of products that are linked to safety signals or identified quality concerns.
By contrast, each batch of drugs imported into the EU must be tested
again within the EU before it can be released for distribution, except
when medicine is imported from countries that have a Mutual Recognition
Agreement (MRA) with the EU. This exemption
means that drugs manufactured in the U.S., Canada, Australia, or
Switzerland are not required to undergo this additional testing, but
drugs coming from India and China are. The responsibilities and
requirements for batch importation testing—applicable to commercial and
investigational medicinal products—are comprehensively detailed in EU
law and applicable guidance, specifically EudraLex Volume 4, Annex 21 (“Importation of medicinal products”).
For imports from countries without an MRA, batch release testing must
be conducted within the EU. The product batches, not just the samples,
generally physically arrive in the EU before the testing is performed,
as EU regulations require testing on samples representative of the
actual imported batch, including shipping conditions. The importer may
use an in-house EU-based laboratory for testing, or they may contract an
EU-based GMP-compliant lab. Import testing in the EU is part of
manufacturing, and laboratories are required to be registered and
undergo GMP inspections.
The importer’s QP then uses lab reports along with other relevant information to determine whether certifying each batch for release is appropriate.
Approach to inspections
Both FDA and EU national authorities conduct inspections to ensure
manufacturing facilities comply with GMPs. Common elements include a
detailed review of manufacturing processes, quality systems,
documentation, and personnel training, supported by risk-based site
prioritization to focus resources effectively. Because the FDA and EU
national authorities have similar standards and approaches, the
respective regulators have signed Mutual Recognition Agreements, which allow the respective regulators to rely on the other’s GMP inspections.
The differences that do exist are perhaps more nuanced. While FDA follows
a more prescriptive, audit-focused approach based on detailed CGMP
regulations, with C indicating the current version of GMPs, the EU employs a principle-based GMP framework. FDA inspections typically culminate in the issuance of a Form 483
listing specific observations, which do not distinguish between their
importance and, for some of them, require documented corrective actions.
In contrast, EU inspections,
generally conducted by national competent authorities with EMA
coordination for sites located in third countries, end with a verbal or
formal inspection report that classifies deficiencies by severity
(critical, major, or other and requires documented corrective actions).
Food importers example
The concept of a qualified person is familiar to FDA through the Foreign Supplier Verification Program (FSVP),
established under the Food Safety Modernization Act (FSMA). Under FSVP,
importers must verify that foreign suppliers meet U.S. safety standards
and maintain adequate records of compliance.
working group that included FDA responded with its draft “good importer practices” guidance,
shifting part of the oversight burden from border inspection to
importers themselves through systematic, risk-based verification of
foreign suppliers. Multiple foodborne illness outbreaks traced to imports reinforced these concerns, and Congress codified these measures into FSMA by creating FSVP.
Just as in the EU drug QP system, FSVP requires a qualified individual—in
this case, the U.S. food importer or their designated agent—to
implement preventive controls ensuring the safety and integrity of
imported food products. The FSVP importer is defined as the U.S. owner
or consignee of the food (or, if none exists, the U.S. agent for the
foreign supplier), making compliance a matter of legal responsibility
for the party with actual ownership or control. Depending on the food
and its hazard profile, verification may include supplier audits, record reviews, or sampling and testing.
Both the EU QP system and FDA’s FSVP use the MRA concept with
countries that have comparable regulatory standards and oversight (under
FSVP, the agreements are called system recognition agreements). Based
on this shared trust, the EU waives batch retesting for drug imports
from recognized partners. With FSVP, the requirements for food importers
from recognized countries are not eliminated but reduced, meaning importers face fewer or less frequent verification steps.
FSVP also does not go as far as the EU QP system in concentrating
accountability or in testing. In FSVP, responsibility for compliance
rests with the importer, not a particular individual. FSVP also does not require
routine batch-by-batch testing of imported food. Instead, U.S.
importers must conduct risk-based supplier verification, which can
include periodic testing when justified by food or supplier risk.
The QP-testing proposal
Adopting elements of the EU’s QP system along with mandatory import testing would require statutory changes to the Federal Food, Drug, and Cosmetic Act.
Given how difficult it can be to pass such legislation, it is
appropriate to ask whether this QP-testing proposal would provide
sufficient benefits to warrant legislative action.
The effectiveness of enforcement systems like FDA’s manufacturing oversight depends on a combination of
enforcement practices, incentive structures, and meaningful
consequences for non-compliance. Assessing proposals by how they shift
this balance helps clarify where the QP-testing approach would bring
differences compared to the status quo.
The current manufacturing oversight system leaves notable gaps in
incentive structure and accountability. Drug facility inspections are
relatively infrequent, particularly for foreign sites, which often have advance notice of upcoming FDA visits. Violations typically result in corrective action plans rather than immediate exclusion from the market. When shortages threaten drug availability, FDA may deliberately temper enforcement by allowing non-compliant facilities to continue production and, in some cases,
permitting substandard products to be distributed under additional
safety measures. Executives authorizing cost-saving decisions that
compromise quality rarely face personal accountability.
Layering a QP system onto FDA’s existing system would change both the
probability of problems being detected and the consequences once they
are uncovered. Detection probability would increase through required
import testing and the additional review conducted by QPs, whether
through documentation checks or site audits. Consequences would increase
because—in addition to the legal responsibility of the firm—the QP
would now be personally responsible for certifying each batch and,
therefore, unwilling to approve products whose CGMP compliance is in
doubt. Conversations with current and past QPs confirm that dynamic.
But this begs another question—why would anyone sign up to be a QP, especially in the more litigious U.S. environment?
The answer lies
in how market access and professional accountability interact, and in
how regulatory design actively counters the QP’s inherent conflict of
interest: QPs are paid by the importer but must maintain strict
independence. In the European system, no batch can reach patients
without a QP’s certification, and the QP personally carries legal
liability for that decision. This dual requirement creates an
equilibrium: companies must secure QPs and offer the authority and
independence needed to fulfill their responsibilities. Without such
assurances, a QP would simply refuse to certify batches, leaving the
company unable to sell.
Over time, the scarcity and indispensability of QPs reinforce their
leverage and professional stature. High turnover of QPs would severely
disrupt supply and attract regulatory scrutiny, which further
incentivizes companies to retain and support these professionals.
In this way, the QP role functions much like other licensed professions that carry statutory responsibilities—auditors in securities law, licensed engineers in public safety, or clinical investigators
in research ethics. Each operates under personal accountability, but
within an institutional framework that balances responsibility with
protections against unreasonable liability.
Nonetheless, translating the European QP system into the U.S. context
might require attention to liability. While a certain degree of
individual responsibility is essential to make the role effective,
unlimited personal exposure could discourage qualified professionals
from serving as QPs. To avoid deterring qualified personnel, legislation
could define the scope of liability in ways that preserve
accountability but prevent excessive or disproportionate personal
exposure—for example, recognizing good‑faith judgments and reasonable
effort.
One other way that liability exposure can be managed is through the
development of QP professional societies discussed earlier. Through
their educational efforts, such societies can help QPs lower the risk of
inadvertent errors. In cases where liability concerns do arise, the
associations also offer access to expert legal counsel and support to
help members respond appropriately to investigations or regulatory
actions, ensuring their interests are represented within the bounds of
professional responsibility.
Design and implementation
Effective implementation of a QP system and enhanced import batch
testing hinges on addressing several design and implementation issues:
designing the QP system, scoping the batch testing requirement,
resolving policy obstacles related to payment, and determining
appropriate phasing to safeguard drug supply. The following Q&A
provides direction in these areas.
Conclusion
FDA’s traditional approach to manufacturing quality oversight faces
growing challenges. As the pharmaceutical supply chain expands globally
and FDA resources remain stretched, it becomes increasingly difficult
for the agency to detect and address quality lapses. When inspections
are infrequent and penalties are limited, manufacturers may be
incentivized to cut corners, increasing risk to quality. FDA’s practice
of regulatory flexibility to avoid drug shortages—allowing noncompliant
facilities to continue producing medically necessary drugs—reinforces
the “too important to fail” dynamic, entrenching systemic
vulnerabilities.
Many recent proposals understandably focus on increasing the
probability of detecting problems through expanding inspection
frequency, enabling unannounced visits, and improving enforcement
resources, particularly overseas. There have also been calls for
increased testing. But addressing accountability has received less
attention, even though it is equally critical.
Introducing a QP system, complemented by mandatory import testing of
every batch, provides a stronger safeguard for drug quality. By
combining mandatory product testing of imports and batch certification
from a qualified U.S.-based person who bears personal sign-off
responsibility, the system enhances both detection and deterrence. Above
all, it underscores that accountability for safeguarding drug quality
and compliance rests squarely with the industry—not with regulators.