Deviations from standard procedures can greatly impact quality and compliance in life science facilities and the pharmaceutical industry. This blog explores best practices for identifying, investigating, and documenting deviations. It covers determining common causes, root causes, addressing issues cross-functionally, and implementing corrective actions. The post highlights how PSC Biotech can help partners overcome deviations through expertise and analytics. Whether a minor process deviation or major nonconformance, this guide provides insights on maintaining quality through effective deviation management.

Identifying and Documenting Deviations in the pharmaceutical industry and life science facilities.

There is a set of established procedures to ensure a quality product in the manufacturing process. These processes are comprehensive to help minimize errors throughout the manufacturing process. When a direction is not followed or a procedure is missed, it must be established if the issue is a deviation. A deviation is departing from a set course or accepted standard.

The deviation itself must follow the governing SOPs that determine the process for deviations. Most companies have a format for deviations, but some things must be addressed in the simplest terms. The deviation must paint the picture of what occurred during the procedure and what was missed or not followed. It is essential to mention the errors that occurred and where in the process they occurred. The purpose of the deviation is to address the issue that arose and clarify whether the procedure is acceptable to continue as such. Sometimes a deviation will explain the problem and state that the process can continue. Still, it might require further investigations that keep the process on hold until another solution or process is created.

Handling Deviations in a Life Science Environment

Getting to the Root Cause of Deviations

Finding the root cause of the deviation might be the most challenging portion of the investigation and is one of the most essential parts of resolving a deviation. Once the root cause is found, it can be addressed with QA. QA will provide insight into the reported root cause and what that means for the procedure overall. This means proceeding as such with deviation or escalating the issue further. The escalation might require further investigations or even up to non-conformance. If that’s the case, the deviation will remain open until the study has concluded.

On the other hand, closing the deviation requires everything to be addressed. This includes the issue during manufacturing or validation, the root cause, the result following the deviation, and whether the current results can be acceptable. Closing the deviation should include a corrective action or preventive action that will address the original cause of the deviation and can prevent it from occurring again. The conclusion of the deviation will be based on the investigation in conjunction with other departments and QA’s final approval. The conclusion will also address the results of the investigation and whether or not the results, product, and procedure can be considered acceptable.

Final Approval and Closure of Deviations

Once the deviation is thoroughly written, addressing all concerns from all the corresponding parties, it can be sent for final review. The owner of the deviation, affiliated departments, and QA will review the document and determine if everything has been addressed. QA will have the final say in approving the deviation. Suppose QA has comments that have to be addressed. In that case, it is pertinent that they get completed and finished because, without QA’s approval of the deviation, the process or machine cannot be used until then and must remain locked out or quarantined.

Once all comments are addressed, the deviation is ready for final approval and closure. This means that every department is satisfied with the investigation and understands that the issues associated with the deviation are corrected.

After the deviation is closed, it can be included in the final report to review and finalize the next documents.

PSC: Your Partner in Deviation Management

At PSC Biotech, we understand that deviations from established norms and expectations can pose significant challenges to the success of life science companies. That’s why we offer a range of solutions designed to help our clients identify, address, and prevent deviations in their processes and systems.

Whether through our advanced analytics capabilities, our expertise in regulatory compliance, or our proven track record of successful implementations, we have the tools and expertise to help our clients overcome deviations and achieve their goals. With our help, life science companies can streamline their operations, improve their bottom line, and deliver high-quality products and services that meet the needs of their customers.