Data Trending Requirements Annex 1, Rev 12

Data Trending Requirements Annex 1, Rev 12

Data Trending and Alert/Action Levels definition are new requirements in the latest EU GMP Annex 1, Revision 12 draft. Trends allow you to quickly and easily identify changes in your cleanroom data and leverage this to make effective decisions, changes, and adjustments often before problems occur. Here we discuss three key components in the latest Annex 1 draft:

1. Trending Relevance: Current Annex 1 vs rev. 12 draft

2. Environmental Trends: approaches and procedures

3. Alert Level Settings: definition and processes

The current Annex 1 does not use the word “trend” at all and used the word “data” only once. The newest draft highlights data throughout, including requiring data trends for activities from high level strategic documentation through to machines and processes:

Trends are highlighted through the Annex 1 draft as a method to effectively identify and maintain the proper quality level at each stage of the production process, specifically to be used as follows:

Trending and data analysis are important and clearly highlighted in the new draft and quoted in every part of the document. Trends are now required in several activities and require day-today, periodic analysis. For example, in Annex 1, draft 12, section 9.10 it states:

   Monitoring procedures should define the approach to trending. Trends can include, but are not limited to:

    1. Increasing numbers of action limit or alert level breaches

    2. Consecutive breaches of alert levels

    3. Regular but isolated breaches of action limits that may have a common cause, for example single excursions that always follow planned preventative maintenance.

    4. Changes in microbial flora type and numbers and predominance of specific organisms. Particular attention should be given to (objectionable organisms or those that can be difficult to control such as spore-forming microorganisms).

To accomplish this a high amount of data must be collected and analyzed on a regular (daily) basis, which requires managing all this data effectively. Fortunately, data management software with modern trending capability for a quick visual analysis is available today.

How can you evaluate all the items required by the new Annex 1?

The new Annex requires not just data collection, but management and analysis such as trends, frequencies of excursions, and more. The question becomes, “how can I effectively accomplish this?”

  1. Start by evaluating the qualification data to use as the base of the cleanroom contamination.
  2. Next look at the continuous monitoring data to understand the performance of your cleanroom during real activities (with personnel inside and operations running).

Alert levels should not be considered dangerous, problematic, or something to avoid, but should be properly configured to avoid adverse situations or address trend issues before a problem occurs. Data trends should be evaluated for short and long time frames to get a complete picture of what is happening and drive corrective and preventive actions.

Life Cycle of Alert / Action Levels

Alert /Action level steps occur as part of a continuous life cycle:

Step 1: Data Collection

  • Data must be collected and managed according to Data Integrity regulations.
  • Time intervals should be chosen according to the process and environment.
  • The use of software to avoid mistakes and save time is strongly recommended and helps meet regulatory requirements.

Step 2: Statistical Evaluation

  • The right statistical tools should be selected according to the data type.
  • External sources of variability should be highlighted.
  • Statistical process control and capabilities studies should be run.
  • The use of statisticians or subject matter experts is strongly recommended.

Step 3: Data Interpretation

  • All external sources of variability must be addressed.
  • The process’s understanding should be the basis of the data interpretation.
  • In the case of data out-of-statistical control, a return plan should be issued.
  • The use of process experts is strongly recommended.

Step 4: Level Settings

  • Based on statistical and process evaluations.
  • Defined to avoid “nuisance” alarms.
  • Able to detect adverse trends in short, medium and long run.

Finally, this is an ongoing process that must be reevaluated on a periodic basis to ensure your alert action level settings are appropriate for your requirements.


Particle Measuring Systems’ Contamination Control Advisory Team

Particle Measuring Systems’ Contamination Control Advisory Team is ready to support you to ensure proper Environmental Monitoring Trend Analysis is in place to assist with advanced statistical analysis for:

  • Environmental Data Trends
  • Alert and Action Level Definition
  • Identifying behavior mistakes, inaccurate sampling positions, and measurement problems through mathematical models

Our team of experienced industry experts brings the expertise you need to ensure your data is effectively managed for conclusive results.

Only Particle Measuring Systems can provide you with complete contamination control solutions including facility monitoring systems and data management. Our modern Environmental Monitoring Systems tools help you to ensure compliancy through data collection, management and reports.

FacilityPro® Data Management Platform
Facility Pro is an industrial control system to assure data integrity, process automation, simplicity of use, and data integration. It connects to various cleanroom sensors, including particle measuring systems viable and non viable samplers, TRH sensors, and more.

PharmaIntegrity ™ Data Management Software
PharmaIntegrity is a data management software designed to exceed current and future regulations. It has Plug and Play features with Particle Measuring Systems’ instruments for fast installation. It provides actionable reports that comply with data integrity requirements and can be accessed from anywhere in the world.

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