New FDA Warning Letter for inadequate Quality Oversight

The FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous deficiencies in the company's Quality Unit (QU), including inadequate oversight and control over manufacturing operations. Issues included unauthorized alterations to production records, undocumented laboratory sample preparation, and failure to retain weight print-outs.

Examples of identified deficiencies:

• Alteration of master batch records by production staff
• Lack of documentation for laboratory sample preparation
• Failure to retain weight print-outs
• QU reviewing only analytical results entered into the enterprise system, neglecting raw analytical data
• Use of laminated production records susceptible to alteration or loss
• Absence of QU access to scanned sheets and logs.

To rectify these issues, the company must devise a comprehensive assessment and remediation plan, granting the QU sufficient authority and resources. Key components include evaluating existing procedures, implementing QU oversight across all operations, establishing a thorough batch review process, and ensuring top management support for quality assurance.