In your pharmaceutical quality assurance career, you may from time to time encounter issues that impact a drug’s quality and performance. Health Canada recognizes this reality, and has outlined steps that pharmaceutical companies must take to deal with these issues in its good manufacturing practices guide for drug products.
However, delivering detailed investigation reports shortly after a deviation occurs is not an easy task. That’s why it’s important to fully understand these reports, so that you’re well-equipped to deal with manufacturing inconsistencies when they arise. Ready to get started? Read on to learn all about deviation investigation reports!
What Is an Investigation Report? A Primer for Those in Pharmaceutical Courses
If you’re interested in pharmaceutical assurance courses, you may have heard of deviation investigation reports, but may not fully know what they entail.
But before we dive in, it is important to understand what a deviation is. It’s generally defined as either:
- An unplanned occurrence that could potentially impact the product in terms of quality, customer safety, and/or regulatory compliance; or
- An event that does not adhere to a company’s standards,such as SOPs, regulatory filings, Master Batch Records, etc.
It is important for professionals to always keep an eye out for errors
A deviation investigation report then clearly and concisely identifies the root cause of the deviation, as well as outlines the steps that have been taken to ensure the safety, purity, quality, strength, and integrity of the product.
The report should be formed as a story that a third party could clearly understand years after it was issued.
How Those in Pharmaceutical Training Describe a Deviation in an Investigation Report
The first portion of an investigation report involves a detailed description of the deviation, including the following elements:
- summary of the event, including the who, what, where, and when
- how the incident was controlled at the time of the event
- what materials were affected
- the impact of the deviation on the product
It is important to meticulously record data, so you can properly analyze the situation
Once you have outlined all relevant information related to a deviation, you can then describe how you got to the bottom of it. In the ‘root-cause investigation’ section of an investigation report, you describe the systemic approach your company took to analyze the issue, including what problem-solving tool was used.
Identifying Measures to Prevent Future Deviations
Of course, simply uncovering a problem and its root cause is not enough. Professionals must also ensure the safety and consistency of future batches, and so corrective action is also necessary. After you have described the deviation and identified its cause, the next section of the investigation report is dedicated to the steps your company has taken to prevent it from happening again.
This section is called the CAPA, or ‘corrective and preventive actions’, which offers solutions for each identified root cause. In this section, graduates of pharmaceutical training also create a plan for verifying the effectiveness of these actions.
The recommendations that an investigation report makes must demonstrate effectiveness
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