Survey Reveals Widespread Use of SPC in Pharma Industry

Phase 3, or ongoing/continued process verification, is the longest stage in the validation life cycle, aiming to confirm that processes continue running under validated conditions and to detect “drifts” and “shifts.” Many companies employ statistical process control (SPC) for this purpose. Concept Heidelberg conducted a survey for the ECA to explore SPC usage, including areas of application, control charts, and process capability limits.

Survey Overview:

• Participants: 34 professionals from companies of varying sizes: 44% from >500 employees, 38% from 101–500, 12% from 51–100, and 14% from 1–50.
• Industry Representation: 74% pharmaceuticals, 32% chemical APIs, 21% biologics, 18% medical devices, 3% excipients.

SPC Applications:

• Areas: Production and QA (70%), laboratories (58%), development (24%).
• Purposes: Trending analysis results (85%), trending manufacturing data (79%), PQRs (79%). Other uses (>20%) included complaints, specification validation, ongoing process verification, stability testing, and deviation investigations.

Conclusion: SPC is widely implemented across multiple areas and purposes in the pharmaceutical industry.

Note: ECA’s SPC course will run online on 5–6 February 2026.

02-02-2026