New FDA Warning Letter because of inadequate Quality Oversight

The US Food and Drug Administration (FDA) recently issued a Warning Letter to a pharmaceutical company in Thailand for violating current Good Manufacturing Practice (CGMP) regulations. The letter cited several deficiencies in the company's Quality Unit (QU).

Specifically, the QU lacked adequate oversight and control over manufacturing operations, leading to issues such as the alteration of production records, incomplete documentation of laboratory preparation, and insufficient review of raw analytical data.

Examples:

• Production staff are able to alter master batch records
• Laboratory sample preparation is not documented
• Weight print-outs are not retained
• QU only reviews analytical results entered into the enterprise system and does not review raw analytical data
• Production records on laminated sheets using erasable markers that could be easily altered or lost
• QU has no access to scanned sheets and logs.

To address these shortcomings, the firm must develop a comprehensive assessment and remediation plan. This plan should empower the QU with the necessary authority and resources to effectively function. Key components of the plan should include:

• Evaluation of existing procedures to ensure they are robust and appropriate
• Implementation of QU oversight throughout all manufacturing operations to ensure adherence to best practices
• Establishment of a thorough review process for each batch and its related information before any disposition decision by the QU
• Oversight and approval of investigations and other QU duties to guarantee the quality and purity of all products
• Demonstration of top management support for quality assurance and reliable operations, including timely provision of resources to address emerging manufacturing and quality issues.

The firm should refer to FDA guidance documents, such as the "Quality Systems Approach to Pharmaceutical CGMP Regulations" for assistance in implementing quality systems and risk management approaches.