In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than others. But maybe we just need a different perspective on what risk management is to inspire us to embrace it. Here are some examples of how simple it can be.
Consider a dinner date, what do you wear?
This type of risk assessment is intuitive, and you do it without even realizing it is a risk assessment. While sometimes you need a more in-depth analysis, quite often it can be this easy to do a risk assessment for work related operations as well. More often than you think, it is enough to document the intuitive risk assessment.
Consider Company A as another example. Company A subcontracts a lot of activities, as many companies in the pharma sector do these days, but in their written procedure for qualifying new subcontractors there is no requirement for risk assessment. They feel the requirements for their subcontractors are known and defined through written directives and are set by different agencies. As long as they ask for the correct certifications and permits, they believe there are no risks to their operations.
Statements like “there are no risks” are results of risk assessments. If a risk assessment has not been completed though, how can you know there is no risk?
No one knows your business better than you. A risk assessment done by a regulatory agency is by default generic and cannot cover specifics for your operations. That is why we are required to always keep a risk-based approach and incorporate risk management into our quality systems.
If there is a generic risk assessment, you do not necessarily need to make yours so complicated. Consider the specifics of your operations and what risks might be applicable, and write it down.
For Company A, a simple one, two, three addition to their supplier qualification procedure is recommended.
This risk assessment will give Company A a very clear picture of their operations and I believe that they have already done this assessment on an intuitive level. If it is also documented, it can be used when a new product is considered to help recognize if it is a product of a previously handled category or if this product comes with additional risks that needs to be addressed. That is a very good starting point for deciding how to qualify a new subcontractor.
August 14, 2019
ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
September 1, 2016
On Tuesday, August 30th, the FDA issued a final guidance document, entitled “Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to Devices.” In the...
September 2, 2016
Additional information on FDA’s guidance document is available in our preceding FDA News article, entitled “FDA Extends Enforcement Deadline for Certain Provisions of the UDI Rule, Part One.” On...