CAPA and Deviation Management

CAPA management stands for “Corrective and Preventive Action” and is a central component of quality management in the pharmaceutical industry. It encompasses systematic processes for identifying, analyzing, and rectifying deviations, as well as implementing preventive measures to prevent future deviations. When a deviation occurs, a corrective action is initially taken to address the immediate problem. Subsequently, a preventive action is developed and implemented to ensure that similar deviations are avoided in the future. Through effective CAPA management, companies can ensure the quality and safety of their products and ensure compliance with regulatory requirements.

What is a Deviation?

A deviation is any departure from approved processes, procedures, instructions, specifications, or established standards. These can occur during the development, manufacturing, labeling, packaging, sampling, testing, storage, and distribution of pharmaceuticals. The definition may vary depending on regulatory requirements and guidelines.

Deviations in Handling CAPAs

FDA Warning Letters and instructions from European authorities provide many examples of possible deviations, as do numerous inspection reports. Here, we limit ourselves to a few key examples for illustration:

  • Timely Delays: One of the most common deviations involves the time taken to process CAPAs. Often, the ability to handle CAPAs within the set deadlines is overestimated, which can be due to an underestimation of the actual processing time and the parallel handling of multiple CAPAs.
  • Impact on Other Ongoing CAPAs: Another common issue is the impact on other ongoing CAPAs, which is difficult to capture in a paper-based system.
  • Changing Goals During Implementation: With longer implementation times, the original goal of the CAPA often changes.
  • Trend Analysis: Trend analyses are necessary for the handling and monitoring of CAPAs but are difficult to conduct in a paper format.
  • Efficiency Review: The efficiency of the CAPA must be reviewed and/or validated.
  • Completion of the CAPA: A frequent problem is the failure to complete the CAPA.

Deviation Management

Deviation management is the systematic process for identifying, assessing, and handling deviations from approved instructions or established standards. The goal is to quickly identify, investigate, and resolve deviations. This is crucial to ensure that pharmaceutical products are safe, consistent, and of high quality, and to ensure compliance with regulatory requirements.

Classification and Categorization of Deviations

There are two main types of deviations: planned and unplanned deviations:

  • Planned Deviations: These are approved in advance to test process improvements, method validations, or temporary process changes.
  • Unplanned Deviations: These occur without prior notice and can be caused by equipment failures, employee errors, or environmental events. They can have significant impacts on product quality and require immediate investigation.

Risk-Based Categorization

Deviations are categorized based on their risk into the following categories:

  • Incident: Unplanned events that have no direct impact on process parameters or product quality.
  • Minor Deviation: Small deviations that have a limited impact on product quality or regulatory compliance.
  • Major Deviation: Significant deviations that have a considerable impact on product quality and regulatory requirements.
  • Critical Deviation: Severe deviations that pose major risks to product quality, patient safety, or regulatory compliance.

Guidelines for Deviation Management

The guidelines for deviation management vary depending on the market and product. Important standards and regulations include:

  • ISO 9001:2015
  • FDA 21 CFR Part 211
  • ICH Q7
  • EU and PIC/S GMP Guide Part 1
  • EU Regulation 1252/2014

These guidelines outline the typical steps in the deviation management process: identification, reporting, investigation, documentation, and implementation.

The Future of CAPA Management with e-QMS

CAPA management is an essential process for maintaining quality and safety in the pharmaceutical industry. The introduction of an electronic quality management system (e-QMS) can significantly change and improve this process. An e-QMS centralizes and automates many of the manual steps traditionally associated with CAPA management, leading to faster and more accurate identification, analysis, and resolution of deviations.

With an e-QMS, companies can manage deviations more efficiently, as it provides immediate access to relevant data and documentation. Automatic notifications and reminders ensure that all parties complete their tasks on time, while integrated workflows and templates ensure process consistency and compliance. Additionally, an e-QMS facilitates trend analysis, monitoring the effectiveness of corrective and preventive actions, and compliance with regulatory requirements.

Are you looking for personnel in the area of CAPA & Deviation Management or would you like to develop your career in this direction? Feel free to contact us – we will find the perfect match for your specific area.

Subscribe to our newsletter

Share post

Call us!
We are looking forward to your message!
Initiative krebskranke Kinder München e.V.

Als Mitglied der Life Science Branche ist es uns eine Herzensangelegenheit, auch einen direkten Beitrag für unsere Gesellschaft zu leisten. Die Gesundheit unserer Mitmenschen ist dabei von besonderer Bedeutung für uns und deshalb unterstützen wir die Initiative krebskranke Kinder München e.V.  


Initiative krebskranke Kinder München e.V.  
Belgradstraße 34 I D- 80796 München I Deutschland I  
Tel. 089/ 534026 I Fax 089/ 531782 I  
Mail I

 APSCO Germany

APSCO Germany (Association Professional Staffing Companies) is the German association for the recruitment industry. Members are international and domestic personnel agencies based in Germany.

The association represents the interests of its members with regard to the Code of Conduct and lobbying and has set itself the goal of making the professional profile of the personal consultant more familiar in Germany. Aristo is a founding member of APSCO Germany. Our management is in the Committee of Representatives.


APSCo International I 101 Borough High Street I London I SE1 1NL I
Phone: 069/ 50 95 75 591 I 
Mail: I 


The Alliance for Independent Knowledge (ADESW) connects leading service providers with highly qualified, independent knowledge workers, as well as associated partners, such as The Association for Mechanical and Plant Engineering (VDMA). The member companies employ more than 4,500 permanent employees. The sector turnover with self-employed knowledge workers amounted to more than 15 billion euros in 2015. On an annual average, the Alliance members jointly fill more than 20,000 projects with independent experts. More than 5,000 customers, among them well-known Dax companies, numerous SMEs and start-ups, as well as federal authorities and other public contracting entities, benefit from this expertise. 


Alliance for Independent Knowledge (ADESW) e.V. 
Karlplatz 7 | D-10117 Berlin | Germany I Phone +49 / 30/ 847 884 100 I 
Fax +49 /30/847 884 299 I Mail info(at) I