Drugs

CGMP Violations in Grupo Contract Test Lab

An 11/20-11/22/2023 FDA inspection at the Grupo Quimico SRL contract testing laboratory in Montevideo, Uruguay, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/30 Warning Letter says the specific violations were:

failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failure to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control or other records.

FDA says it considers contractors as extensions of a manufacturer’s facility. “Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients,” it says. “It is essential that you understand your responsibility to operate in full compliance with CGMP when performing analytical work for your customers. As part of this responsibility, it is essential that you provide prompt, complete, and transparent analytical information to your customers (e.g., manufacturers) to enable them to handle their quality responsibilities related to batch evaluation and contractor oversight.”

The letter says Grupo’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. The agency recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements.

The company’s response to the inspection observations was inadequate because it did not provide supportive documentation for evaluation and evidence of completed corrections. Grupo was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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