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Real compliance and how to achieve it.
PDA Journal of Pharmaceutical Science and Technology
|April 20, 2001
Summary
Achieve real compliance through effective systems and control, not just rule-following. This approach reduces costs and improves efficiency, moving beyond the limitations of traditional regulatory compliance.
Area of Science:
- Management Science
- Quality Management
- Regulatory Affairs
Background:
- Traditional regulatory compliance focuses on adhering to external rules, which can be costly and inefficient.
- Constantly changing regulations create moving targets, increasing the risk of citations and operational challenges.
Purpose of the Study:
- To differentiate between traditional regulatory compliance and a more effective 'real compliance' model.
- To outline the principles and methods for achieving 'real compliance' for improved business outcomes.
Main Methods:
- Defining 'real compliance' as a state of unconditional control.
- Emphasizing product and process-based systems, effective policies, and robust warning systems.
- Highlighting key strategies: knowledge plus control, process monitoring, quality systems, principle-based procedures, skilled personnel, and proactive systems.
Main Results:
- 'Real compliance' offers the benefits of regulatory compliance without the drawbacks.
- This model significantly reduces costs through increased production and control efficiencies and lower training expenses.
- It fosters unconditional control, independent of specific regulations.
Conclusions:
- Transitioning from rule-based regulatory compliance to principle-based 'real compliance' is crucial.
- Implementing effective quality systems and fostering a state of control leads to sustainable compliance and operational excellence.
- Focusing on inherent control and process improvement, rather than external inspections, ensures consistent quality and efficiency.