Pharmaceuticals 2011 - Avoiding “Failure to Investigate" Observations by Conducting Effective Investigations

Why Should You Attend:

The Current Good Manufacturing Practice for Finished Pharmaceuticals regulations of the US Food and Drug Administration require investigations to be conducted per 21 CFR Part §211.192 regulations.

Although this regulation has been in effect since 1978, organizations continue to struggle with the effective conduct and documentation of investigations to meet the expectations of regulatory authorities. An FDA guidance document regarding “Out-of-Specification Investigations” was finalized in 2006, but primarily covers the investigation of “chemistry-based laboratory testing of drugs regulated by the Center for Drug Evaluation and Research (CDER)”.

Establishing an effective system of conducting investigations, to ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is an essential requirement for the manufacture and commercialization of all FDA regulated products.

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