Six Systems Approach to Pharmaceutical cGMP Regulations

Six Systems Approach to Pharmaceutical cGMP Regulations.

The FDA has enacted several pharmaceutical cGMP regulations. These are key concepts that are critical to quality systems. Some of the concepts by which the FDA and other regulatory bodies ensure cGMP regulations are Quality, Quality by Design (QbD) and product development, Quality Risk Management, Corrective and Preventive Action (CAPA), Change Control, and the Six Systems Approach.

Of these, the six-system inspection approach is a systems-based approach to cGMP and is aimed at ensuring a robust quality system model for pharmaceutical products.

It consists of the following:

Quality System

• Facilities System
• Equipment System
• Materials System
• Production System
• Packaging & Labeling System

Quality system is the fulcrum

It needs to be borne in mind that the whole system centers round the organization’s quality system. The quality system is the pivot around which the systems approach revolves. It is the core and the very foundation for the manufacturing systems that are linked and function within it. 

The FDA does not consider the quality system as different or separate from the five elements. In this sense, it the quality system model may be considered the root from which the five elements branch out.

In other words, the five manufacturing systems integrate themselves them into the respective and appropriate sections of the model. The order of interplay and interdependence may vary slightly from one organization to another, but to those in the knowhow of the six-system inspection approach; the rationale by which the inter-relationship plays out is quite readily apparent.

State of control –the crux of the matter

The entire purpose of having a systems approach in which the systems are independent, yet integrate into each other seamlessly is that having a systems-based inspection compliance program ensures that the organization is equipped with the ability to assess whether each of the systems is in a state of control.

 References:

http://www.fda.gov/downloads/Drugs/…/Guidances/UCM070337.pdf

Thanks & Best Regards,
John Robinson
GlobalCompliancePanel
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Web: www.globalcompliancepanel.com
Email: john.robinson@globalcompliancepanel.com

2 thoughts on “Six Systems Approach to Pharmaceutical cGMP Regulations

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