Guidelines for Production Personnel Conducting Sampling in GMP Environments

Sampling of raw materials, intermediates, and finished products is a critical quality activity that directly affects product quality, patient safety, and GMP compliance. Personnel performing sampling must be trained, qualified, and approved, in accordance with EU GMP Guidelines (Chapters 1.9, 2, and Annex 8) and other regulatory frameworks. Training should cover sampling plans, procedures, equipment handling, contamination risks, precautions for unstable or sterile materials, and accurate documentation.

Production personnel can perform sampling under defined conditions. They must receive documented training, follow clear SOPs, and operate within a supervisory framework that ensures independence where necessary. Regardless of who conducts the sampling, the Quality Unit remains responsible for oversight, ensuring representativeness, data integrity, and compliance.

In essence, sampling is a quality-critical task that may involve production staff if risk-assessed, procedure-driven, and supported by continuous training and quality oversight, safeguarding regulatory compliance and product safety.

23-09-2025