Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Despite the best efforts of industry and regulators alike, quality issues are on the rise. Product complaints are up, along with product recalls, drug shortages, product bans, plant shutdowns, and enforcement actions. This means that industry and regulators alike are looking for answers.

Fortunately, many of these answers lie within your existing Deviation Management processes and data. The key is understanding the true driver behind Good Manufacturing Practices (GMP), and then structuring your deviation and quality management processes accordingly.

Ultimately GMP is all about patient care and the achievement of customer expectations through conformance to their requirements. It’s all about improving the life of the patient using the product. That’s why regulators are increasingly digging into not just the ability to comply with regulations, but the ability to produce high-quality product.

GMP and the Product Lifecycle

Let’s take a closer look at GMP and the pharmaceutical product lifecycle. The management of Deviations is not just a GMP concept, it spans the entire product lifecycle. The concepts we’re about to discuss can also apply to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP). Here we’re focusing on GMP because the need to properly manage deviations is compounded by the fact that the product is in the broad market.

At a minimum, GMP requires written procedures for the following:

• Control of components, drug product containers, and closures
• Production and process controls
• Packaging and labeling control
• Holding and distribution
• Laboratory controls
• Complaints

Additionally, while there are various GMP standards, each of them, whether it is the International Conference on Harmonisation (ICH), the FDA, or the EU GMP standard, requires the documentation of any deviation.

Deviation Management Defined

A deviation is any departure from an approved instruction, procedure, specification, or standard.

Planned deviations are pre-approved deviations from the current operational document or system, covering a specified period of time or number of batches.

Planned deviations must be approved before execution. Planned deviations should be handled through approved change control procedures. All changes should be evaluated for product impact, significance, and the need for requalification or revalidation.

Generally speaking, manufacturers should work hard to not use planned deviations, as minimal planned deviations demonstrate process control, stability, and repeatability.

Unplanned deviations are also known as incidents, unplanned events, or uncontrolled events. Examples of unplanned deviations include:

• Human error
• Malfunction or breakdown of equipment or instrumentation
• Utility or service failure
• Yield deviation

An unplanned deviation indicates a state of noncompliance from the designed systems or procedures at any stage of manufacturing, packaging, testing, holding, or storage of drug product.

Managing deviations and other unexpected quality events is required by GMP, but properly capturing and measuring these events builds the foundation for the quality improvements that regulators will demand from your organization as they renew their focus on quality.

The New Mission: Focus on Quality

Let’s investigate just one example of a regulatory body’s renewed focus on quality. The Center for Drug Evaluation and Research (CDER) published in November of 2016 its most recent Guidance for Industry on the Submission of Quality Metrics Data.

The three metrics required are:

• Lot Acceptance Rate
• Product Quality Complaint Rate
• Invalidated Out of Specification Rate (IOOSR)

Each of these metrics focuses on determining product and process quality and sustainability. What does this mean for the Pharmaceutical industry? It means manufacturers need to think differently about quality and the systems they deploy to manage it, because quality data is becoming critical to compliance.

The Need to Think Differently

In this age of big data, structuring your global quality system data is imperative, and properly structured data sets are a must. The goal of properly structured data sets is to turn data into actionable information through its transformation. Properly structured quality data may be transformed into KPIs, quality and compliance metrics, and other measures that can be used consistently at a business unit, division, or site level. For each process, for products and product families, and for customers and suppliers around the globe, this data structure is essential within a global enterprise quality management system.

A Single Source of Quality Truth

Beyond metrics and compliance, the destination of the journey to global enterprise quality management is arriving at a single source of quality truth for the organization. This includes information from the many sources of deviation data that a global, integrated quality system provides. It is no longer sufficient for the quality management system to be the company historian, recording the events of the organization. Those events, or more accurately the data from those events, must be turned into information — information that can be used to identify and diagnose quality problems, and predict and prevent quality events as well.

The ability to identify and respond to opportunities for improvement needs to be added to the charter for enterprise quality management, along with the proper use of the information that deviation data can provide. Whether that data is coming from planned or unplanned deviations, out of specification results, complaints, or other nonconformances, it will open the door for improved quality through controlled change management.

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