Regulatory News

A GMP deviation is never just a single event; it triggers a structured and often resource-intensive regulatory process. From root cause analysis to effectiveness checks, each step requires expertise and knowledge of what is required.

Annex 15 is about to become far more relevant for API manufacturers. Stronger requirements for deviation investigations and process understanding will raise the bar for quality oversight across the supply chain.

Each holder of a manufacturing authorisation for medicinal products in Europe needs to name at least one Qualified Person (QP). A QP's function and responsibility is therefore unique.

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.