Where Did GMP Go?

The basic concept of Good Manufacturing Practice (GMP) is based on two key quality principles:

• Processes and procedures are designed and validated to assure products are manufactured to meet specification and perform as expected for the customer.

• Employees are trained on processes, follow procedures and empowered to stop the line whenever there is a problem or failure.

While GMP is a requirement in regulated industries, the basic principles are applicable in any business. Essentially, applying GMP is just good business sense.

If we accept the above statements as truth, and GMP is truly effective, why are we seeing more product recalls and increased enforcement activities by the FDA? As quality systems have matured through implementation of systemic approaches, there have been other major changes in industry that have contributed to the regulatory compliance issues that appear in current FDA Warning Letters.

• The introduction of MRP/ERP systems to industry. The intent of these systems is to automate processes and streamline activities. Line automation eliminates the need for employees to be actively involved in the process. As a result, some of the checks and balances implemented during the original product/process design may be eliminated if appropriate risk management assessments aren’t performed.

• Lean Six Sigma practices have become more prevalent in industry. While lean manufacturing and Six Sigma are wonderful quality tools, they are often implemented with more focus on financial outcome than quality improvement. Legacy processes often include manual checks and intervention at key steps to inspect quality into the product. As lean was implemented through operation, many of these manual steps were eliminated from manufacturing activities

• Employees are trained to follow procedures and steps in the process. Checklists have been implemented to facilitate compliance to procedure. This approach is sometimes mistaken as an alternative for employees to be held accountable for the quality of the work performed.

An Example

A specific example in my experience involved the implementation of line automation in conjunction with a major lean project. The initial analysis of the line identified a step requiring a manual visual check to assure the reagent was being dispensed into the vials. It was determined to be non-value added by management. As a result, the manual visual check was eliminated from the process. The process was validated and checklists put into place.

A couple of weeks later, the complaint volume on the product spiked because customers were receiving empty vials. The root cause investigation identified elimination of the visual inspection. When operators were trained, there was no mention to check that liquid was being dispensed, as it was assumed to be common sense. Employees followed the procedure without question. Accountability for common sense was “leaned” out of the process.

KEY LEARNING EXPERIENCE: GMP relies on employee accountability and understanding of the process, as much as the documentation of what was done. Line automation and lean Six Sigma projects do not eliminate the need for employee involvement. Let’s not forget these important attributes as business and quality systems tools continue to evolve.

About the Author

B. Christine Park is a quality systems consultant with expertise in the implementation and remediation of sustainable and regulatory compliant quality systems. She has led the successful implementation of quality systems in large corporations, as well as small start up companies. Her industry experience and background supports compliant yet practical, pragmatic quality systems. She can be contacted at 678-480-5411 and cpark928@mindspring.com

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