Regulatory News

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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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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European QP Association Developments September through December 2025

Find out what the European QP Association was working on and accomplished in the last four months of 2025 - in the latest report.

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Is QP Certification required when Products do not enter EU Territory?

The EMA has published a new Q&A addressing the requirement for Qualified Person (QP) certification of batches that are neither manufactured or physically imported in the EU/EEA market.

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Decentralised Manufacturing: New UK Framework in Operation

A new post, "Decentralised Manufacturing: emerging considerations" has just been published by the UK MHRA, reflecting the current approach.

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Is QP Release possible after deviating In-Process Controls?

Did you know that EMA's Questions and Answers Section to Annex 16 further clarifies the role of the QP in the context of handling unexpected deviations during from in-process controls?

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European QP Association Developments May through August 2025

Find out what the European QP Association was working on and accomplished in the second four months of 2025 - in the latest report.

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European QP Association Developments January through April 2025

Find out what the European QP Association was working on and accomplished in the first four months of 2025 - in the latest report.

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FDA Warning Letter with Supplier Qualification Observations

A US company received a Warning Letter because of problems at their CMO. FDA points out that companies should have a robust qualification process for CMOs.

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QP Declaration: New Q&As published

The European Medicines Agency (EMA) has published a Q&A document on how third-party audits should be reflected in Part C of the QP Declaration.

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