ECA Survey Results I: How is Statistical Process Control used in the Pharmaceutical Industry?

Phase 3 (ongoing/continued process verification) is the longest phase in the validation life cycle. This phase is intended to demonstrate that the process continues to run under validated conditions. The aim is to identify “drifts” and “shifts.” Many companies use statistical process control (SPC) for this purpose. Concept Heidelberg conducted a survey for the ECA specifically on this topic. Among other things, the ECA wanted to know whether SPC is also used in other areas, which control charts are used, what limit values exist for process capability indices, etc.
 
34 participants took part in the survey. Not every participant answered every single question: sometimes several answers were given by the same person, and rounding also contributes to the fact that the total sum of the answers does not always add up to 100%. Below is part I of the results.

Biographical Data

Most participants came from companies with more than 500 employees (44%), 38% of participants work in companies with 101-500 employees, 12% come from companies with 51-100 employees, and 14% from companies with 1-50 employees.

The majority of participants (74%) manufacture pharmaceuticals. Chemical active ingredient manufacturers accounted for 32% and manufacturers of biological pharmaceuticals for 21%. Manufacturers of medical devices also accounted for 18%, and 3% came from excipient manufacturers.

Survey results Part I

Things got exciting when it came to the question in which areas SPC is used (multiple answers were possible).  Here, 70% cited production and quality assurance. 58% cited the laboratory area, followed some way behind by development (24%).

 
And for what purposes is SPC used?
Multiple answers were also possible for this question. The following were mentioned:

• Trending of analysis results: 85%
• Trending of manufacturing data: 79%
• PQR: 79%
• More than 20% of the answers were “Other”

The following were mentioned under “Other”: “Complaints, suitability of specifications/validation, continuous process verification, stability testing, deviation investigations, ongoing process validation.”

Resumee: SPC is widely used in the Pharmaceutical Industry and for different purposes. In part II you can read among other things, if there are problems with control charts, which control charts are used and which statistical methods are used for the evaluation.

PS. On 5/6 February 2026 ECA´s SPC course will be running online.