Aaryan Rana (3)
I am an experienced digital marketing analyst with a passion for data-driven insights, optimizing campaigns, and driving business growth with 3years exp.
Introduction
The pharmaceutical market has faced
various challenges during COVID-19, including adhering to additional regulatory
standards. Due to stringent FDA pharmaceutical regulations, pharma companies
always need to stay upto date on their compliance tools. Many pharma
manufacturers feel that following best practices and maintaining higher quality
standards would turn into a hindrance to business productivity. However, with
the right technology strategy , Pharma companies can employ the same standards
to increase their overall productivity.
On an average, about 4,500 drugs and devices are pulled from U.S. shelves each
year.Source: US FDA
Planned and unplanned FDA audits are
common in the industry. Companies that don’t meticulously maintain accurate
records tend to struggle when an unplanned inspection occurs. FDA inspections
are needed to ensure that companies adhere to all compliance requirements. No
organization should struggle to find the necessary details to justify
deviations, out of spec procedures, batch approvals, and so forth. Read on more
to know why Pharmaceutical companies fail FDA audits and how they can be more
prepared when a random audit occurs.
FIGURE
1:The six systems that are CFR 21 Part 11 compliant
Why Pharmaceutical Companies Fail FDA Audits?
An FDA audit gives Pharma companies
a perspective on how well prepared they are. A forthcoming GMP audit can even
serve as a driving force for long-awaited business initiatives. Hence,
pre-audit preparations are all about focusing on quality issue identification
and its resolution. However, FDA audits can be stressful for the Product
Quality Management Officers, Quality Risk Managers, and other personnel
responsible for ensuring GMP throughout the process control. As shown in Figure
1, the six systems that are CFR 21 part 11 compliant have to installed with the
right processes to record data accurately.
There are a series of factors that
contribute to audit failures in pharmaceutical companies. Given below is a
brief comparison of the major ones.
FIGURE
2:Factors Incurring Audit Failure
Coping up with Various Types of FDA Audits
Every Pharmaceutical company is
bound by FDA regulations and can expect an audit sooner or later. These audits
ensure process compliance relevant to Standard Operating Procedures (SOPs),
good manufacturing practices (GMPs), and other regulatory criteria. FDA may
conduct four different types of inspections depending on purpose and timing.
1.FDA Pre-Approval Inspections (FDA pai):A pre-approval inspection may occur after the
company submits a new product to FDA. This audit intends to verify the data you
have included in your application and ensure that your equipment plus
facilities are appropriate for manufacturing the finished product. FDA
determines the pre-approval inspection with a risk-based approach, product
type, and process risk. Process risk factors in development data and whether
the process is appreciably new to any you have done before.
Getting a pre-approval
inspection indicates that your company meets QMS requirements and can continue
with the protocol. The required rule for pre-marketing audits originate from
FDA, so it is possible to prepare ahead. A pre-approval inspection’s potential
outcome is that the inspectors will either recommend for or against FDA
approval.
2.Routine Inspections:Companies manufacturing class II and class III products will
experience a routine inspection once in a couple of years. The purpose is to
ensure that everything is still running according to the prescribed protocols.
These audits follow the dual-level of the Quality System Inspection Technique
(QSIT).
· Â
Level 2 Baseline QSIT:Â This is very inclusive and covers almost all the quality
systems, corrective and preventive actions (CAPA), design controls, management
controls, and process controls. Pharma companies plan FDA inspections and
prepare ahead based on previous events.
· Â
Level 1 Abbreviated QSIT:Â This is a brief inspection conducted when the company has
undergone a Level 2 Baseline. A CAPA system integrated with a Quality Control
and batch manufacturing system help with more meticulous preparation.
Information well streamlined and available at your fingertips makes you
safeguarded when a sudden inspection occurs.
The type and frequency
of audits largely depend on what the auditors find. If there is any public
health risk unveiled during a routine check, they would possibly conduct a
follow-up or for-cause inspection.
3.Compliance Inspections:These inspections review actions undertaken by a manufacturer in
response to a previous audit that resulted in a noteworthy 483 observations.
FDA office issues Form 483 observations when an inspection indicates violations
in good manufacturing practices (cGMP). FDA will schedule a compliance
follow-up audit to check if the company has responded sufficiently and has
corrected its previous violations. The FDA may record current violations and
opt for future regulatory action if you fail to meet requirements. A company
will be well aware of this audit if it already has 483 observations or any
warning letter. It should most probably, identify the issues that the FDA had
found and address them quickly. It all comes down to well-managed
compliance/follow-up audits, by fixing violations and be prepared with
additional information concerning inventory, batches, and quality control.
4.For-Cause
Inspections:These audits are
in-depth and don’t happen as often as the other three. For cause audits to
investigate a particular problem reported to the FDA, such as from
manufacturers (recall of products, MIDR), consumers (complaints and feedback),
and even employees. Companies should expect an audit in case of any health
hazard or a severe product recall. There are no set guidelines here, and the
type of inspection appears to be spontaneous. Irrespective of the QSIT, the
auditors have a free hand to probe into other areas and aspects of the company
besides the impending issue. The best way to manage this audit is to prepare
for a regular FDA inspection considering you may not receive any advance
notice. A real-time QMS, up-to-date management reviews, and internal
investigations can adequately serve the purpose.
The Digital Connect
Almost every pharmaceutical company
should comply with the FDA’s Title 21 CFR Part 11 Guidelines, commonly known as
the ‘Part 11’ regulation. All records fall under this regulation when digitally
stored, signed and processed as part of its business. Information security,
hence, becomes significant for Part 11. All authorized users in the company
require appropriate security permissions. So, managing a company’s protocols
related to quality compliance can be very well achieved by digitization.
Unique usernames and passwords can
provide access to user records. Moreover, this can also help monitor batch
traceability with the right approvals in the warehouse. FDA audit will become
straightforward when there is a record of every event in inventory with
accurate time, date, and username. Electronic data further includes e-signatures,
digital stamps, scans, etc. Under Part 11 compliance, these signatures must
satisfy the primary & authentic cryptographic criteria abiding by a
specific set of rules. The e-signatures and scans must retain an individual’s
identity and the integrity of the corresponding data.
Compliance, being a perpetual
process, needs continual vigilance of electronic records and signatures.
Accordingly, the right digital solution for Pharma can streamline quality
workflows and minimize non-compliance.
Key Takeaways
·     Â
Pharmaceutical
industries are more vulnerable to production & quality failures if a
company is not proactive to handle FDA audits.
·     Â
An effective training
program ensures that SOPs and regulations are transparent to employees. The
intent is to get them to prepare for an FDA audit by keeping product and
quality documentation up to date.
·     Â
Digital transformation for Pharmaceutical will
hugely assist in meeting compliance criteria. It can keep pace with the
increasing surge of data, make you prepared for FDA audits, and prevent the
undesired consequences.
Article comments