Regulatory guidelines documentation compliance

Drug Application Regulatory Compliance. This Web page offers guidance documents, compliance policy programs and guidelines, and frequently asked questions about compliance activities. 

Implementation will improve efficiency as well as quality compliance by consistent application of regulatory guidelines. Ancillary benefits include the ability to retrieve documentation quickly for an FDA inspection and the development of accessible product histories, which can be electronically passed to operations as products move from development to commercial sites. 

The pharmaceutical manufacturer must establish effective policies and plans for regulatory compliance and validation to enable individuals to clearly understand the company commitment and requirements. Computer validation planning should ensure an appropriate training program, preparation of validation guidelines and procedures, system GMP compliance risk and criticality assessment, a documented validation strategy and rationale, clearly defined quality-related critical parameters and data for the manufacturing process. 

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