News

What did the FDA criticise in the Design of a Water System?

In a recent Warning Letter, the FDA addressed deficiencies in a water system. Two references from the US GMP rules are cited. On the one hand, 21 CFR 211.63 with reference to equipment and, on the other hand, 21 CFR 211.100 with reference to process controls ('validation'). What bothered the FDA?

More
Concept Paper Annex 15 Revision published

In the working plans of the European Medicines Agency (EMA) a new revision of Annex 15 was proposed in 2024. Now the concept paper for this revision has been published on EMA´s website.

More
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. 

More
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?

More
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. 

More
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.

More
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.

More
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?

More
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.

More
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?

More
x
Search