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GMP News

04.02.2026

When Training Falls Short: FDA Findings on GMP Training Deficiencies in 2025

Adequate training of personnel in the GMP-regulated environment is the basis of a compliant pharmaceutical quality system. However, in 2025, insufficient employee training has been a frequent finding in FDA inspections.

04.02.2026

ECA Survey Results II: 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. 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 which control charts are used and what the limits are for cpk-values, etc. Read part II of the survey results summary.

04.02.2026

Endotoxins Testing: Potential Change for WFI and Steam in the USP

In Pharmacopeial Forum (PF) 52(1), January 2026, the USP proposes to add an alternative endotoxins test using recombinant reagents. This would affect, among others, the monographs for Water for Injection (WFI), Sterile Water for Injection and Pure Steam.

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