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What could be more crucial to global health than maintaining the safety of drugs? A risk assessment audit is vital to keep drug quality as high as possible. This audit, including alarm records, is essential for pharmaceutical regulatory compliance.

Joseph Alford

The experts in bio-pharma risk management know Joseph Alford as a titan of auditing. He received his B.S. in Chemical Engineering from Purdue University. Alford followed that with a two-year stint as a U.S. Navy engineering officer aboard a Vietnam War-era aircraft carrier. His duties there honed his grasp of the control of critical processes. After leaving the military, Alford earned an MS and Ph.D. from the University of Cincinnati.

After taking a position at Eli Lilly, Alford lead the development of a fermentation-process-control and data historian system. Eli Lilly used this system company-wide. Alford subsequently became chief computer validation auditor. Retired from Eli Lilly, Alford remains active as a consultant. He continues to be a leader in risk assessment.

The audit

Alford’s principles point to three elements of a compliance risk assessment audit:

  • Alarm systems.
  • Monitoring and continuous improvement.
  • Alarm records.

Alarm systems must tag alarms related to product quality. These are known as critical process parameters (CPPs). Quality control should check all CPP alarms before a lot can be released or held back. A proper audit looks at how alarm limits for CPPs are determined. It also checks into the training of operators dealing with alerts. Alarm policies must be written, and systems should not allow unauthorized policy changes.

Monitoring and continuous improvement require regular review by plant management. This process should include an active program to find and remove nuisance alarms.

Alarm records historian that stores alarm records, should have a way to meet customers’ needs to generate batch records and readily allow sorting and querying. Further, the system must contain clear descriptions. A historian should also be able to access a Pareto utility to create bar charts of alarm frequency activations.

Food and Drug Administration (FDA) recommendations

As a part of Current Good Manufacturing Practices (CGMP), the FDA looks at how record-keeping rules apply to all the products it covers. CGMPs address many issues. The FDA intends the CGMP rules to be flexible, allowing companies to use newer technologies and innovate for continuous improvement.

The FDA inspects pharmaceutical facilities worldwide for compliance with CGMP regulations. These facilities include manufacturers of both ingredients and finished products. If the FDA finds a facility is not following CGMP regulations, the law considers drugs it produces “adulterated.” The FDA pursues regulatory actions against companies with poor CGMPs. These actions prevent the production of ineffective or unsafe drugs.

For audit trail regulations, the FDA will decide whether to require time-stamped computer-generated records. However, it requires complete documentation of events with no obscured entries.

Noting the time, date and sequence may not be necessary for any specific instance. Still, an audit trail should ensure complete and reliable records. The agency recommends that companies look at documentation system effects on quality, safety, and record integrity. When creating, changing, or deleting records in the normal course of operations, audit trails form a key part of a quality system. Alarm management is a crucial aspect of these trials.

Making alarm management work

Companies must effectively sort alarm data to identify and track CPP alarms as regulations require. Unfortunately, many facilities can’t do this as well as they might. As a result, historians get data with thousands of alarms. That vast number makes it difficult to extract the most helpful information. This data may also contain many nuisance alarms, which make it even more unwieldy.

Batch processes, in particular, may generate large numbers of nuisance alarms. TiPS LogMate® and its modules address this problem. They help operators and facilities analyze alarm data to reduce nuisance alarms. This process improves response and provides continuous improvement. Contact TiPS to learn more about effective alarm management.