As noted in our January 1st, 2025 report –  some companies are overly reliant on their suppliers’ Certificates of Analysis (CoAs) and are failing to confirm the appropriateness of testing. This practice has led to significant 483 observations, highlighting gaps in quality control and regulatory compliance.

Certificates of Analysis serve a critical function in supply chain management. They provide essential details about the identity, purity, and potency of raw materials, intermediates, and finished products. However, CoAs are only as reliable as the systems and controls behind them. GMP regulations explicitly require firms to independently verify the adequacy and appropriateness of the tests rather than solely depending on supplier-provided information.

Case Study #1: Distributors and Finished Product Testing

In one FDA inspection, a distributor was cited under 21 CFR 211.165(a) for failing to justify the appropriateness of its suppliers testing of  the finished product before release. Instead, the distributor relied entirely on a CoA provided by its Contract Manufacturing Organization. While the CoA included appearance and assay specifications, the adequacy of these tests was not verified. This oversight left the distributor vulnerable to quality risks and regulatory action. The observation read as follows: 

Your firm failed to ensure that …, Lot # … manufactured by your Contract Manufacturing Organization (CMO) under Batch # … and …, had undergone appropriate finished product testing prior to being released. While the Certificate of Analysis (CoA) from the CMO mentioned appearance and assay testing criteria and specifications, there was no indication that they were adequate and appropriate.

The takeaway? Distributors must justify the appropriateness of laboratory testing to ensure conformance to final specifications for the drug product.

Case Study #2: Manufacturers and Active Pharmaceutical Ingredients

Another inspection uncovered deficiencies in a finished product manufacturer’s handling of active pharmaceutical ingredients (APIs). The firm was cited under 21 CFR 211.84(d)(2) which states:

Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. In lieu of such testing by the manufacturer, a report of analysis may be accepted from the supplier of a component, provided that at least one specific identity test is conducted on such component by the manufacturer, and provided that the manufacturer establishes the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.

The 483 Observation read 

Your firm has not performed identity testing on the active pharmaceutical ingredients and your suppliers have not been qualified. For example, your firm relies on … testing and the certificate of analysis from suppliers for active pharmaceutical ingredient

By relying solely on CoAs, the manufacturer bypassed a critical layer of quality assurance, exposing itself to risks.

How to Mitigate Overreliance on CoAs

To address this trend and strengthen GMP compliance, companies should take the following steps:

  1. Perform Independent Testing: Conduct identity, potency, and purity testing for all incoming materials and finished products, regardless of CoA data.
  2. Establish Robust Supplier Qualification Programs: Conduct regular audits, risk assessments, and performance reviews to ensure suppliers meet GMP standards.
  3. Document Quality Control Processes: Maintain comprehensive records of all testing and verification activities to demonstrate compliance during inspections.
  4. Invest in Staff Training: Educate quality teams on regulatory expectations and the risks of overreliance on CoAs.

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