Lessons from 483 Inspections: CFR 21 Part 211

March 15, 2024

In the highly regulated world of drug and biotechnology manufacturing, adhering to FDA regulations is essential not just legally, but also for protecting patient health, ensuring quality and building market trust.

This blog highlights a critical trend: over 50% of the compliance issues noted during FDA Inspections (as documented in 483 Letters) for drug manufacturers (including some biotechnology firms) have focused on specific sections of FDA CFR 21 Part 211. This indicates a crucial area for compliance improvement to maintain operational integrity and uphold industry standards. 

Understanding CFR 21 Part 211 and Recent Observations: 

FDA CFR 21 part 211 outlines the regulations for the manufacturing, processing, packing, or holding of drug products. Its focus is ensuring these products are safe and meet quality standards.  

Recent observations have concentrated on two key sections:  

  • Section 211.22(d): Emphasizes the responsibilities and procedures of the quality control unit, highlighting the necessity for robust oversight and adherence to procedures. 
  • Section 211.192: Focuses on establishing drug product production and control records, mandating thorough investigations and accurate documentation before any batch release or distribution. 

These sections are crucial for implementing rigorous quality control measures. However, the recurring observations point to a systemic issue where companies often fall short, particularly in the areas of procedural documentation and adherence.

Understanding the Core Issues 

The recurring themes in FDA observations revolve around: 

  • A lack of written procedures or failure to follow those procedures 
  • An inadequate review of discrepancies 
  • Insufficient documentation of investigations into these discrepancies 

Such lapses not only compromise product quality but also reflect poorly on an organization’s commitment to compliance and operational excellence. 

Leveraging Technology for Improved Compliance and Quality Assurance 

Merit for Life Science offers a comprehensive solution to address these challenges by providing tools to: 

Dealing with incidents, deviations, non-conformances, and CAPAs 

By integrating deviation management directly into the system, Merit for Life Science ensures that any deviation, regardless of its origin within the system, is addressed through a standardized, enforced process. This approach not only facilitates immediate corrective action but also provides a transparent, auditable trail of compliance activities. 

The Role of Electronic Documentation and Training 

A critical aspect of compliance is the establishment and maintenance of written procedures, as mandated by sections 211.22 and 211.192.  

Merit for Life Science addresses this need through GXP Documents, a platform that allows for the creation, management, and revision of essential documents, ensuring they are readily accessible for review and application. This capability is closely tied to the system’s training functionalities, which ensure that all personnel involved in deviation management are appropriately trained, with their training status documented and auditable. 

Take the Next Step

Learn more about how GxP Documents can assist with establishing written procedures for your organization or contact a Merit Solution Expert.