Pharmaceutical and medical device manufacturers operate under strict guidelines to ensure that their products meet the necessary health and safety standards outlined by regulatory bodies.

To keep their products and processes in line with these standards, life sciences manufacturers must pay attention to deviation management as part of their quality management efforts. This practice allows such manufacturers to detect and rectify problems before they compound into more disastrous results for the business.

For instance, non-conforming processes can result in major quality defects, increasing the risk of products being distributed that could result in harm to the end consumer. Consequently, the business incurs financial and reputational damage from customers and regulatory bodies.

Nevertheless, modern life sciences manufacturers have never been more equipped to stay on top of their deviation management process by leveraging robust technology and software.

In this post, we’ll review some common causes of product deviation and how manufacturers are managing and reducing product deviations using digital solutions.

What is a product deviation?

In the pharmaceutical and medical device manufacturing space, product deviations entail a departure from the norm. In other words, the processes and the resulting products don’t conform to the standards set before the manufacturing run.

For instance, an incident in the lab can bring a momentary halt to work, pushing the process off the standardized track set by the quality management team. Generally, the various possible non-standard events come in different forms, necessitating manufacturers to stay on top of them.

Planned vs. unplanned deviations

Not all deviations are created equal. As a result, life sciences manufacturing businesses gauge product deviations depending on the type of incident. These incident types are typically categorized as planned and unplanned deviations. The differences between the two incident types are as follows:

Planned deviations: Such deviations are also referred to as temporary changes. This is because manufacturers intentionally make these changes to existing protocols in the most up-to-date operational document.

Pharmaceutical and medical device manufacturing businesses implement these deviations to avoid more catastrophic developments in their processes. For instance, a manufacturer decides to make smaller product batches when their raw material supply dwindles. Alternatively, a manufacturer might tweak their process to avoid using broken equipment.

In some cases, planned deviations may be beneficial as they provide a business with the opportunity to re-evaluate its standardized processes. If a manufacturer determines that their deviation resulted in a more efficient, productive process, they may decide to implement the deviation as a new standard operating procedure.

Unplanned deviations: These incidents are usually unforeseen, causing deviations from approved standard practices across the production process. For example, a power outage can bring the entire factory to a standstill, affecting critical components of the manufacturer’s GMP principles.

Known as uncontrolled events, unplanned deviations drive a manufacturing business to implement control mechanisms to correct or even prevent the resultant damage.

Unplanned deviations are graded according to their effect on product quality. Incidents like unauthorized personnel don’t necessarily affect product quality, whereas minor events like small documentation errors may have minimal impact on GxP or product quality.

Alternatively, major deviations like broken equipment significantly impact production, and critical deviations such as contaminated raw materials greatly affect product quality.

Causes of product deviations

Seemingly minor quality events can initiate a domino effect, resulting in more significant issues down the production line or in later processes. As such, life sciences manufacturers should know the root causes of these deviations. Some of the common causes can include:

Human error: Although modern life sciences manufacturers have embraced automation, many processes still require some degree of human input. As such, these processes may result in deviation due to a mistake by operators.

Contamination: Manufacturers in the pharmaceutical space require clean, sterile rooms to ensure that their products don’t cause health conditions for the customer. However, sometimes contaminants make their way into work environments, compromising workspace and product integrity.

Equipment breakdown: It is not uncommon for machines to malfunction or break down in a manufacturing setting, particularly if they’re not properly maintained. This downtime affects both upstream and downstream production processes, causing deviations in manufacturing activities and product quality.

Raw material conditions: Even when manufacturers account for every step of their production processes, product deviations can still occur. In many instances, an outside factor is to blame. Commonly, the condition of the raw materials affects the end product.

If the raw materials are contaminated or of poor quality, the end product might fall significantly short of necessary quality standards.

Process unknowns: In other instances, the cause of the product deviation might be more challenging to isolate. This is mainly due to the complexity of production processes within the life sciences industry. As a result, the manufacturing process contains several potential areas of failure and variation that can lead to product deviations.

What is deviation management?

The deviation management process involves identifying, assessing, and correcting deviations from product quality standards and good manufacturing practices. Managing deviations expands further to incorporate factors across the entire product lifecycle. The basic deviation management process unfolds as follows:

  1. Identification: Because deviations can occur in different areas for different reasons, relevant, responsible personnel should identify the event details and categorize the deviation accordingly.

  2. Reporting: After obtaining the pertinent details, personnel should report the deviations to the quality manager. Manufacturers should have proper reporting channels and operating principles to ensure a standardized and open line of communication.

  3. Investigation: The quality manager – working in tandem with the affected department – undertakes root cause analysis to identify the origin of the deviation. If the cause affects product quality and current good manufacturing practices (cGMP), the quality team should identify potential corrective and preventative actions (CAPA).

  4. Documentation: Manufacturers must document all the steps to identify, report and correct the deviation. Not only does this provide a consistent and detailed audit trail, but it also ensures that life sciences manufacturers adhere to national and global regulations.

  5. Implementation: Details from the investigation stage inform the ideal corrective action the relevant personnel should implement. Therefore, quality managers should guide the scope of corrective action to ensure that the deviation doesn’t reoccur.

In all cases, pharmaceutical and medical device manufacturers should have a plan in place to manage deviations as they arise.

Using a tool like Tulip, operators are more easily able to prevent deviations by eliminating the cause of human error, as well as identify deviations more quickly by leveraging inline quality control and real-time reporting to limit the impact.

If you’re interested in learning how Tulip can help improve your deviation management processes, please reach out to a member of our team today!

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