How to Use Pharmaceutical Manufacturing Metrics to Measure Quality

Posted by David Watt

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In drug product manufacturing, quality is everything. Inconsistent quality can result in manufacturing delays, additional costs and a shortage of available products. Preventing and swiftly resolving any issues will benefit many stakeholders — including the client, the manufacturer and, ultimately, the end user of these products. Objectively speaking, then, how is quality defined?

Assessment Qualification with a CMO PartnerQuality refers to both the facilities and the processes used in manufacturers’ operations. Health Canada has established Good Manufacturing Practices (GMP) and the U.S. FDA has set Current Good Manufacturing Practice (cGMP) regulations as standards for the production of safe and effective products. Compliance with these guidelines includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories.

Key Performance Indicators

To measure quality within your manufacturing environment, you and your manufacturer could establish hundreds of metrics. However, prioritizing a few select key performance indicators (KPIs) is important in order to maintain efficiency.

A few key performance indicators include:

  1. Overall Equipment Effectiveness (OEE)
    Measures operating efficiency as Availability x Performance x Quality. For the calculation of availability, performance and quality, factors include run time, planned production time, ideal cycle time, good count and total count.
  2. Throughput Efficiency
    Measures how much product is being produced on a machine, line, unit or plant over a specified time period. For a CMO, that might include the quantity of tablets per day or bottles per minute.
  3. Downtime
    Includes both scheduled downtime (such as preventive maintenance or capital projects installation) and unscheduled downtime (equipment breakage or malfunction, production that is not to specification).

KPIs will help your organization identify whether you’re ahead or behind in production, and over time, they will also track process improvements. 

Best Practices to Achieve Quality in Manufacturing

Analyzing metrics for their own sake isn’t especially productive. Instead, use them to shed light on the inconsistencies and challenges in your manufacturing environment. Here are three ways to achieve efficiency and avoid defects:

Implement processes.

They ensure a seamless workflow. Avoid duplication of effort across departments and reduce errors.

Increase asset utilization.

Increase shifts or run time as necessary to achieve a greater asset availability.

Apply the appropriate tools.

This improves decision making and reduces workload. That could mean hiring Six-Sigma-certified employees, as WellSpring has done, to move from basic spreadsheets to a material requirements planning (MRP) system to manage inventory and scheduling. 

By implementing best practices that have the greatest impact, you’ll move beyond compliance and be better able to meet your customer commitments.

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Topics: quality, key performance indicators, best practices, metrics, compliance

David is the Technical Director in the Business Development Department at WellSpring, and has over twenty years of pharmaceutical GMP experience in technical definition and evaluation of Contract Development and Manufacturing projects, both from provider and client perspectives. David has previously worked at Valeant, Medicis, Patheon and Syntex Pharmaceuticals. David is responsible for overseeing all technology transfer activities in the organization.

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