Optimizing Your Internal Process for FDA Compliance

PharmaManufacturing.com
06/14/2007

The FDA has been releasing new guidelines to improve pharmaceutical product manufacturing quality and safety. One example are the FDA's guidelines for Quality Systems Approaches to Pharmaceutical Current Good Manufacturing Practice (CGMP) Regulations issued late last year. Pharmaceutical leaders agree that the best defense against FDA scrutiny, regulatory audits, production delays and shut-downs is an effective and efficient quality function.

Best Practices, LLC's benchmarking report "The Quality Function: Structure, Staffing and Execution" reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders.

The report compares structure, staffing, roles and responsibilities. These insights will provide executives with specific direction for marked improvement and will aid your company in making informed budget, resource allocation and process improvement decisions for your quality function.

Download the complimentary excerpt with sample findings and a detailed table of contents at www3.best-in-class.com/rr814.htm.

Indeed, executives from Abbott, Lilly, J&J, GlaxoSmithKline, Wyeth and others shared wisdom and key insights for honing elite quality functions within their organizations. For example:

• Successful companies integrate quality checks into the process on an ongoing basis. One company has created documented procedures for its main quality processes to reduce the need for managers to monitor tasks on a daily basis.
• Savvy companies recognize that quality auditors can prevent internal issues from becoming external problems for a manufacturer. All manufacturing employees at this company annually complete 12 standard training modules, regardless of job position. The full report contains best practices on the following topics:
• Staffing & Professional Development - practices for developing key skills in quality employees. The chapter also includes information about methods for forecasting and managing staffing needs.
• The Quality Mindset - practices related to developing a quality- oriented culture within the quality organization and the manufacturing function in general. The chapter includes practices related to goal setting and performance measurement.
• Integrating Audit and Improvement Efforts - practices in the area of auditing and ongoing improvement efforts. Included practices examine methods for tracking audit findings and improvement efforts.

For more information, download a complimentary excerpt of this benchmarking report "The Quality Function: Structure, Staffing and Execution" at www3.best-in-class.com/rr814.htm.