New ECA Guidance on Sampling and Sample Management

The ECA Analytical Quality Control Group (AQCG) has developed a new document: Laboratory Data Management Guidance – Sampling and Sample Management. Version 1 of the document was released on 30 April 2025.

This guidance continues the sequence of previously published guidance documents. Like previous AQCG publications, the PDF file is available for free in the AQCG members area. For further information and to register for a free membership, please visit the group's website.

Content

The guidance was authored by Dr Christopher Burgess, Chairman of the AQCG. The board members contributed to the internal review process, while the external technical review was conducted by Jane Weitzel, an Independent Consultant and Chair of the USP General Chapters – Measurement & Data Quality Expert Committee.

The document underscores the critical importance of sampling as a potential error-generating process and details the requirements for establishing robust sampling protocols to minimize variability and maintain data integrity. Additionally, the guidance elaborates on the critical steps involved in the sampling process, from statistical sampling plans to sampling protocol design, and the documentation of sampling records.

The document also provides practical examples and illustrative figures to assist laboratories in implementing effective sampling strategies and ensuring regulatory compliance.

Chapter Structure

The document is structured as follows:

• 1 Introduction to AQCG & its Guidances
• 2 Importance of Sampling and Sample Management
• 3 Regulatory Requirements for Sampling and Sample Management
• 4 Theory of Sampling
• 5 Nomenclature of sampling
• 6 The Sampling Process
• 7 Sampling Procedure & Protocol
• 8 Sampling Record
• 9 Additional Guidance sources on sampling
• 10 Sampling is only part of the Analysis and Testing Process
• 11 References

In total, the document comprises 24 pages, 12 illustrations, and 34 references.

Free Webinar

A free webinar (approx. 45 min presentation + 15 min Q&A) will be held for all AQCG members.

• Date: Tuesday, 17 June 2025
• Time: 10 am CEST
• Speaker: Dr Christopher Burgess

You can find the registration link directly in the members area. The presentation slides will be made available shortly before the event, and all members will have the opportunity to access the recording afterwards.