COS-GMP Section 6 Explained: Personnel

By Robert Low, Lead Management System Specialist

Section 6 of COS-GMP covers personnel — organisation, responsibilities, competence and training, hygiene and health, and visitors. The structure closely parallels ISO 22716’s Section 3, but COS-GMP is noticeably more explicit about senior management’s documented commitment and about training record detail.

This post is part of a series working through COS-GMP section by section. The series summary with links to every section is available at the end.

What the Standard Covers

General and Senior Management commitment. The organisation needs to document who it considers “Senior Management” — specifically including the senior-most manager responsible for the organisation. Senior Management needs to evidence its commitment to GMP by developing, documenting, and publishing a GMP policy summarising the organisation’s GMP culture, written so it is easily understood and actually communicated to all personnel — not filed away unread.

Responsibilities of personnel. All personnel need to know their position, their responsibilities, have access to relevant documents, comply with hygiene requirements, and be encouraged to report irregularities. Senior Management needs to ensure responsibilities and authorities are documented, including a clear statement of the GMP system’s importance, who implements procedures, and who acts as point of contact for third parties.

Organisation. A documented organogram needs to show each Technical Compliance department as independent from production, with clearly assigned and documented deputies for all key roles — a more explicit deputisation requirement than ISO 22716 states directly.

Competence and training. Training needs identifying for all personnel regardless of position, with records covering the trainee’s name and confirmation of attendance, date and duration, course content, the training provider, and — distinctively — details of the competency assessment carried out and the level of achievement reached. This goes beyond ISO 22716’s general training evaluation requirement by specifying exactly what the record needs to contain. Inductions need to cover hygiene rules, the GMP policy, responsibilities, and organisation-specific awareness, with GMP awareness training refreshed at least annually for everyone.

Hygiene and health. Hand-washing facilities need sufficient water at a suitable temperature, suitable drying facilities, and prompt-use signage. Eating, drinking, and smoking are prohibited in GMP control zones, with a specific exception for water drinking stations where a risk assessment supports it. Personal medication should be avoided in control zones where possible, or controlled case by case through risk assessment.

Visitors and contractors. A system for evaluating the health status of visitors and contractors needs establishing before granting site access, with records maintained — commonly implemented as a visitor questionnaire.

Where This Commonly Goes Wrong

The most common gap is the GMP policy requirement — many organisations have informal commitment to quality from leadership, but a specifically documented, published GMP policy that has actually been communicated to all personnel is a distinct, more formal requirement that often does not exist as a standalone document.

The second common gap is competency assessment detail in training records. Attendance records are common; documented evidence of the actual competency level achieved, rather than simply confirmation of attendance, is less consistently captured.

How This Connects to the Rest of the System

Training records connect directly to competence management, and the documented organisational independence requirement connects to how nonconformance and CAPA decisions get authorised — Technical Compliance needs genuine authority to make quality decisions independent of production pressure.

This post is part of the Cornerstone COS-GMP series. See the full series summary with links to all 11 sections.