The letter, sent March 5, summarises a number of significant violations of current good manufacturing practice (CGMP) regulations for testing finished pharmaceuticals observed during a US Food and Drug Administration (FDA) inspection in September last year.
The Agency found the firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.
“For example, your non-compendial test methods used to analyze your customers’ drug products had not been validated,” the FDA said.
Furthermore, the firm was slammed for adding a comment to a Certificate of Analysis (CoA) to inform a customer that the analyses are conducted using “unvalidated” test methods.
“It is essential for a contract test laboratory to use validated or verified methods to ensure that results of pharmaceutical analyses subject to CGMP are accurate,” the Agency said. “Accountability in the supply chain is compromised when a CoA reports that results conform to specification without assurance that the test methods used were reliable. Including a disclaimer does not release you from the CGMP requirement to ensure that your test methods are validated and suitable for their intended use.”
The company was also found to have failed to thoroughly investigate unexplained discrepancies in batches.
Citing a response from October 2017, the letter added Quali-Controle & Quali-Controle said dirty glassware used in all prior preparations and tests was the root cause for the failures and that rinsing the glassware before testing resolved the problem.
However, the firm’s response was “inadequate because you have no scientific justification for the assigned root cause, nor have you implemented adequate corrective actions and preventive actions (CAPA).”
The FDA added: “As a contract laboratory, you must comply with the CGMP regulations that apply to operations you perform, including but not limited to those that address the operations of your quality control unit, laboratory, investigation systems, documentation systems, and other facets of your operation.”