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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. 

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New FDA Term in the Field of Equipment

A Canadian drug manufacturer received a Warning Letter due to its GMP deficiencies. Among other things, deviations from 21 CFR 211.67 (a) were found. What did the FDA criticise?

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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. 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, etc. Read the results of the survey in Part I. 

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Process Validation covers the entire Manufacturing Process

The latest interpretations of regulatory GMP requirements are often based on inspection results. The FDA Warning Letters are very openly accessible in this regard. Here you read about an example for the interpretation of CGMP in the context of process validation.

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Validation Group Developments September through December 2025

Find out what the ECA Valdiation Group was working on and accomplished in the last four months of 2025 - in the latest report.

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FDA Warning Letter Statistics on Medical Devices in the Past Fiscal Year 2025

On behalf of the ECA Concept Heidelberg regularly evaluates the deficiencies in FDA Warning Letters regarding medical devices. Since medical devices can be part of a combination product consisting of a medicinal product and a medical device (there are other combination options in the USA), these statistics are also of interest to manufacturers of these products. What do the statistics for 2025 look like?

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Qualification does not replace Validation

In the past, some companies considered qualification to be sufficient and did not carry out prospective process validation. A recent Warning Letter from the FDA highlights the consequences of this approach.

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Documented Evidence - a fundamental Principle at the FDA

Documented evidence is a fundamental principle of the FDA in the GMP environment. A recent Warning Letter illustrates this using the example of a lack of cleaning validation. What does the FDA expect?

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Validation Group Developments May through August 2025

Please see the ECA Validation Group's report on what they were working on and what they accomplished between May and August 2025.

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FDA Warning Letter for both missing Process and Cleaning Validation

The FDA's current process validation guideline has been in force since 2011. The issue of cross-contamination has been mentioned in 21 CFR 211 since 1978, and the FDA Guide to Inspections on Cleaning Validation dates back to 1993. Process and cleaning validation have therefore been established procedures in the pharmaceutical environment for a long time. But what happens if neither process nor cleaning validation is in place during an FDA inspection?

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