deviation in the pharma industry no deviation

Deviation in the pharma industry: what it is and what to do when it occurs

Pharmaceutical quality is quintessential. Any departures from pharmaceutical quality are called deviations and can occur at any point during a process or product lifecycle. Deviations can impact system integrity, product quality and public health and safety. 

While regulatory requirements are firmly established for the industry with various technology and experience levels, the aim, however, is always to achieve quality. If quality is built into every process, then compliance will come naturally. A company’s culture is a crucial parameter when it comes to deviation and CAPA management, and the establishment of a quality culture starts right at the top and is shared by everyone in the organisation. 

At No deviation, we are constantly aware of how a quality mindset and proactive approach will ultimately provide value to both patient and the pharma company. In fact, ‘No deviation’, the desired state that every single organisation strives towards, is the ideal that our CEO, Pierre Winnepenninck, started the company on, back in 2007. We continue to uphold this ideal and help other pharma and related industries build quality in their product. 

Here is a practical look at what to do when a deviation occurs. 

Once an incident occurs/is discovered, it has to be escalated immediately to the Supervisor and QA. Once the situation comes under control, the Deviation Initiator/Owner (depending on the company’s procedure) will formally initiate a Deviation using the company’s pre-defined template. A typical deviation investigation leverages multiple Quality System elements such as Corrective Action and Preventive Action (CAPA) and Quality Risk Management (QRM). 

After the deviation initiation has been approved by QA, a Deviation Investigation Report shall be prepared. The Deviation Owner plans on how to conduct the investigation by forming an Investigation Team and choosing appropriate QRM tools for the Root Cause Analysis. Here are some of the examples: 

  • Fishbone Analysis / 6M (Man, Machine, Material, Method, Measurement & Mother Nature) 
  • 5 Whys 
  • Process Mapping 

Once the root cause has been determined, CAPA may be put into place (depending on the criticality/complexity of the deviation) to ensure that the same deviation does not re-occur. In addition to CAPA, a Recurrence Analysis can be performed as well. This is to identify whether there have been any past events of similar nature, as this might signal that “something is not right” in the system, and there might be a need to review the current Quality System, Qualification, and/or Validation procedures etc. for improvement. 

At last, a conclusion shall be included in the report to summarise the investigation as a whole. If the closure requirements are satisfied, the Deviation Investigation Report can then be closed upon approval by QA. 

There may be slight differences between different companies but ultimately, patient safety, and product quality and safety are always at the heart of whatever we do. Also, it is crucial to formally document every part of the investigation, including supporting attachments, as part of data governance in conjunction with the ALCOA+ principles. 

To sum it up, the essence of performing a deviation investigation is to find the true root cause, remediate, and prevent future occurrence, with patient safety and product quality and safety in mind. Hence, it is important to perform an in-depth and thorough deviation investigation in order to ensure safe and quality products for the customers, that are in compliance with relevant regulatory requirements. Nobody likes deviation in the pharma industry, but it could drive us towards improvement! 

At No deviation, we partner with you to help you build the quality in your product. Reach out to us to know how we can help you achieve, retain, and regain cGMP compliance. 

You can also visit our website for more information on our services.

If you have any questions, please get in touch with Alyaa Amirah, Compliance Engineer or HyeSu Lim, Engineer at No deviation, the co-authors of this article.