Who is allowed to perform Sampling?

Sampling of raw materials, intermediates and finished products is a critical quality-related activity. It directly impacts product quality, patient safety, and GMP compliance. Therefore, the question of who is permitted to perform sampling is not merely operational – it is a matter of regulatory control, data integrity, and audit readiness.

Training Requirements

It is clear that the personnel must be trained and approved for sampling. This already follows from the general principles described in Chapter 2 (Personnel) of the EU GMP Guidelines Part I or Chapter 3 (Personnel) of the EU GMP Guidelines Part II, according to which personnel with the necessary qualifications and practical experience must be available for all GMP-relevant activities and should receive initial and continuing training

Chapter 1.9 of the EU GMP Guideline Part I further states: "Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by approved personnel and methods".

Annex 8 (Sampling of Starting and Packaging Materials) of the EU GMP Guidelines additionally stipulates the following: "Personnel who take samples should receive initial and on-going regular training in the disciplines relevant to correct sampling. This training should include:

• sampling plans,
• written sampling procedures,
• the techniques and equipment for sampling,
• the risks of cross-contamination,
• the precautions to be taken with regard to unstable and/or sterile substances,
• the importance of considering the visual appearance of materials, containers and labels,
• the importance of recording any unexpected or unusual circumstances."

This makes it clear that sampling is a quality-critical task requiring not only procedural clarity, but also continuous qualification of the involved personnel – regardless of their departmental affiliation.

Can Production Personnel perform Sampling?

The answer is yes — under certain conditions. Regulatory frameworks, including EU GMP, ICH Q7 and various national guidelines (e.g. FDA, PIC/S), do not categorically prohibit production personnel from performing sampling activities. However, requirements must be fulfilled:

• Documented training and qualification: Production personnel must be specifically trained – typically by QA/QC departments – in sampling techniques, container handling, contamination control and documentation procedures.
• Clear SOPs: Standard Operating Procedures must define when and how production staff may sample, what materials are included (e.g., excipients, APIs, packaging), and under what supervisory framework.
• Independence and segregation of duties: In certain situations, independence from production may be required to avoid bias or conflicts of interest.
• Quality Oversight: Even if production staff conduct the sampling, the Quality Unit (QA/QC) retains responsibility for ensuring the process is controlled, the samples are representative, and the data are reliable.

In summary: Production personnel may perform sampling if this is risk-assessed, clearly defined in procedures and supported by documented training.