Despite MRAs, not all types of inspections are recognised in practice; for example, "for-cause" inspections have so far not, or only rarely, been covered. These are also increasingly conducted without prior notice.
The EMA has published a new version of the '3-year work plan for the Inspectors Working Group' for the period January 2026 to December 2028. This includes planned changes to the EU GMP guidelines.
The texts of the Regulation and Directive of the new EU pharmaceutical legislation (EU Pharma Package) have been published. Only one formal step remains before the documents can enter into force.
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.
When it comes to supplier qualification, it is unfortunately still often forgotten that audits or audit reports are only one component of supplier qualification, albeit an important one. Read on to find out what else is involved.
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.
Version 4.0 of the technical interpretation on legal requirements for foreign trade and supply chain traceability defines concrete and enforceable obligations.
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 which control charts are used and what the limits are for cpk-values, etc. Read part II of the survey results summary.
