The FDA issued 466 Form 483s to drug organizations in FY 2022, more than double the previous year, highlighting significant quality failures in the pharmaceutical sector. For startups and scale-ups seeking market approval, the excitement of innovation often conflicts with the strict requirements of current good manufacturing practices (cGMP). Although receiving a 483 indicates quality system issues, it is not necessarily fatal for the organization.

Many companies, including startups and established entities, struggle with FDA regulations. It is crucial to create an organization that proactively ensures compliance rather than merely reacting to inspections. This discussion highlights the underlying causes of regulatory failures and how Zenovel is designed to address these issues.

Main Source of Compliance Failure

The FDA’s annual inspection findings repeatedly showcase similar deficiencies within pharmaceutical companies, including absent procedures, inadequate laboratory controls, and insufficient investigations. Although the exact figures may vary, the persistent patterns underline ongoing systemic issues that lead to recurrent compliance failures among organizations.

Most common factors such as:

Lack of Proactive Approach

Many organizations adopt a reactive approach to compliance, focusing on passing audits rather than maintaining ongoing operational integrity. This reliance on memory and informal methods can lead to compliance gaps, particularly when key personnel are unavailable. Rather than being a final goal, compliance should be viewed as a continuous process to avoid issues, such as receiving an FDA Form 483.

Fragmented Data and Broken Workflows

In a traditional paper-based or fragmented digital environment, information is isolated in various formats, such as maintenance logs on paper, training records in spreadsheets, and deviation reports in emails. This disorganization can lead to FDA citations, as seen with maintenance activities logged improperly and records lacking necessary signatures. Such broken workflows hinder the quality control unit’s ability to conduct effective reviews, allowing for overlooked discrepancies and resulting in citations for failure to investigate, with 104 observations reported in 2022.

SOP Trap

Standard Operating Procedures (SOPs) serve as a roadmap for quality, but many companies encounter the “SOP Trap,”

• where these documents become static: written, approved, and subsequently forgotten, leading to obsolescence and non-compliance.
• Inaccessible SOPs: are frequently inaccessible, often written in an unreadable language for operators or secured in a manager’s office binder.
• Vague SOPs: that state “the laboratory is responsible for” rather than specifying “the Lab Manager must” lead to confusion and reduced accountability.

Human Error and Lack of Visibility

Many 483s arise from human error, such as forgetfulness or lack of training. Without a centralized tracking system, these errors can lead to systemic compliance risks. Effective management requires measurement and tracking of actions.

How Zenovel is Maintaining Compliance?

Escaping the cycle of reactive compliance necessitates a fundamental change in quality management, shifting from hope to designing an inevitable compliance system. Zenovel offers the infrastructure to facilitate this transition, aiding companies in preemptively addressing common fitfalls.

We have following services for making compliance ready infrastructure

Computer system validation:

In today’s data-driven regulatory landscape, maintaining the integrity of computerized systems is crucial to avoid citations related to laboratory controls and data governance. Zenovel offers comprehensive Computer System Validation (CSV) services, ensuring compliance with regulations like 21 CFR Part 11 for systems such as Laboratory Information Management Systems (LIMS) and Enterprise Resource Planning (ERP) tools. Our methodology focuses on validating systems to uphold data integrity, prevent unauthorized access, and establish transparent audit trails, thus mitigating inspection problems proactively.

Contract Staffing Solution:

Compliance failures often arise from overwhelmed teams or absent specialized skills. We provide Contract Staffing Solutions that connect organizations with pre-qualified experts, such as quality assurance professionals or clinical monitors. This service ensures operational continuity by integrating compliance knowledge into daily workflows.

Pre inspection readiness & Mock Inspection:

We provide services in Pre-Inspection Readiness and Mock Inspections, aiding in the preparation by organizing operations, training personnel for inspector interactions, and conducting gap assessments to identify non-compliance areas. This proactive approach enables corrective actions and ensures confidence during inspections.

Plant upgradation & set-up:

Our Plant Upgradation and Set-Up services ensure facilities are designed for compliance with GMP standards from the start. We offer guidance on facility design, process optimization, and infrastructure development, facilitating upgrades without disrupting ongoing production and embedding quality into operations.

Consulting

Our Consulting Services provide strategic guidance on GMP and GCP compliance, including the development of Quality Management Systems (QMS), regulatory gap analyses, product registration support, and process improvement. We aim to align company objectives with quality policies to enhance compliance while promoting operational efficiency and sustainable success.

Zenovel offers a partnership that aims to enhance compliance from a reactive state to a proactive and confident one, providing both expert infrastructure and strategic support.

Ready to establish a compliance-ready infrastructure or regulatory adherence? Discover our services or reach out to discuss your specific requirements.