Deviation & CAPA Management.
Identifying, planning, and improving processes.

What are Deviation & CAPA Management?

Defining deviations.

Deviations & CAPA Management is the process of systematically dealing with unforeseen or unplanned occurrences that ‘deviate’ from established or Standard Operating Procedures (SOPs), guidelines, or specifications during the lifecycle of pharmaceutical and life sciences products.

Deviations can be categorized into two primary types: planned deviations, which are expected and pre-approved, and unplanned deviations, which occur suddenly and without forewarning.

  • Planned deviations are foreseen and authorised in advance, often due to temporary alterations in processes or procedures. They are carefully monitored and documented to ensure patient safety, product quality etc.
  • Unplanned deviations occur suddenly without notice and can arise for various reasons like equipment malfunctions, human errors, or other unexpected circumstances. These deviations need to be quickly identified, documented, and investigated to assess their impact on product quality and safety, following which corrective and preventive actions can be implemented.

 

Examples of deviations.

  • Failing to follow safety SOPs or guidelines, which can impact patient safety and compromise Pharmacovigilance Compliance.
  • Equipment breakdown or malfunction that can result in potential contamination or inaccurate test results.
  • Raw materials or supply chain challenges that can cause changes in product composition or quality.
  • Human errors, including miscalculations, mislabeling, or failure to follow established procedures.
  • Alterations in environmental conditions, such as temperature, humidity, or air quality, that can impact the stability or sterility of the product.
  • Unexpected delays in manufacturing, testing, or distribution processes leading to product degradation or expiration.

 

Deviations are typically defined in one of four general categories and definitions to help safety, compliance, and operating prioritization:

Incident: Deviations that don’t affect regulatory compliance or product quality.

Minor: Deviations from established procedures or standards that have a noticeable but limited impact on regulatory compliance or product quality.

Major: Deviations that are a significant departure from established procedures or SOPs which can have a substantial impact on regulatory compliance or product quality.

Critical: Deviations with a direct impact on patient, personnel, or environmental safety.

Deviation Management System.

It is important therefore to create a well-structured deviation management system to identify recurring deviations, uncover the underlying issues and trends behind them, and take Corrective And Preventative Actions (CAPAs) to improve processes, prevent future deviations, and reduce risks.

Key reasons to implement a Deviation Management System include:

  • Regulatory and guideline compliance.
  • Ensuring product quality and safety. 
  • Identifying and resolving potential risks and process issues.
  • Enhancing organisational learning and continuous improvement.

Typical steps and responsibilities within Deviation & CAPA Management:

  • Identification of the deviation.
  • Reporting the deviation in a formal document.
  • Investigation of the deviation to determine the root cause.
  • Resolution and CAPA implementation.
  • Documenting all steps and actions to create a full audit trail.

 

CAPAs & CAPA Management.

Following the steps of deviation management requires a thorough root cause analysis into why the deviation occurred. This is a fundamental first step that paves the way for effective CAPAs.

Techniques such as Fishbone Diagrams or the 5 Whys can systematically unearth the underlying factors leading to a deviation, pinpointing exactly what caused it.

Once the root cause or causes are identified, appropriate corrective and preventative actions can be implemented to directly address those root causes and mitigate or eliminate the risk of their recurrence.

A critical part of the CAPA process is evaluating the effectiveness of the actions to assess if they have the expected effect, and if not to update them, but good CAPA Management should address the root cause to ensure that the actions should always be successful.

Information from the EMA about deviation, change and CAPAs under the ICH guideline Q10 on pharmaceutical quality system, Step 5.

Information from the EMA about risk assessment and management under the ICH guideline Q9 on quality risk management, Step 5.

Why choose Aegisana for Deviation & CAPA Management?

A structured system.

Aegisana’s Compliance team is fully experienced in all aspects of deviation & CAPA management, using, or creating, a well-structured deviation management system to identify clear roles and communication with all the relevant stakeholders involved.

We work with your personnel and cross-functional teams through each step of the process from identification to CAPA effectiveness assessment to ensure issues are reported, documented, resolved, and monitored for success.

Our CAPA Management services include, but are not limited to:

  • Compliance review for proposed CAPAs.
  • CAPA recording in your own or Aegisana’s QMS.
  • Monthly reporting and follow up of outstanding CAPAs.
  • Extension review and deviation requests for overdue CAPAs.
  • Post-audit CAPA response document Management.

Focused on preventing failure.

Deviation & CAPA Management is an essential part of understanding and preventing failures and learning from them to make real organisational change. Inadequate CAPA planning is a common inspection concern inline with the expectation of continual learning and best practice development vs isolated problem fixing.

Our objective is to provide you with peace of mind and confidence that comes from knowing your processes are being handled by an expert team providing a meticulous and detailed service grounded in effective communication, reliability, and trust.

Through the establishment of a successful and robust strategic compliance partnership, we aim to offer comprehensive support across all our service areas, providing expert solutions throughout the entire life cycle of your human and animal products.

All of our services adhere to the regulations and principles of the EMA’s guidelines on compliance.