GMP in Practice for Manufacturing and Operators

Two days of practical training, for operators among others.

Most contamination in a cleanroom does not come from the building or the equipment. It comes from people. This two-day in-house program is built around that fact.

Day 1, GMP foundation. A shared day that gives everyone the same vocabulary: what GMP asks, how a quality system actually works, what a signature commits you to, and why procedures alone do not produce quality culture. It closes on own responsibility: recognising that something has gone wrong, stopping, and reporting it.

Day 2, contamination control and behaviour. Day 2 takes that foundation into the production environment. Participants meet the microorganisms they are working against, learn the reasoning behind every hygiene requirement rather than just the requirement itself, and practise gowning and disinfection with direct feedback from the trainer. The day covers what the building, HVAC and pressure cascades protect against — and, just as importantly, what they do not.

The day ends in a practical cleanroom scenario. The group finds the deviations, argues about the borderline cases, and has to decide what to do. 

Practical requirement: garments, gloves, disinfectants and a suitable table are provided on site for the gowning exercise. Where these cannot be supplied, the exercise is simplified.

Operators, manufacturing staff and technical support functions who work in production areas and classified environments. No prior GMP knowledge is required — day 1 builds the foundation and day 2 applies it to the floor.

Suitable for entire production departments, including staff who have followed GMP training before but have never practised gowning and disinfection under direct feedback.

Day 1, GMP foundation: quality and quality systems; documentation and data integrity; GMP behaviour; deviations, change control, CAPAs and risk management; records and evidence; quality culture; own responsibility in GMP; workshop.

Day 2, contamination control and behaviour: cleanroom behaviour and consequence; microbiology; personal hygiene and health; practical gowning and disinfection exercise; buildings, rooms and installations; training and qualification; cleanroom scenario workshop.

Participants leave able to explain why the hygiene and behaviour rules exist rather than only that they exist, to gown and disinfect correctly having practised it under feedback, and to recognise a deviation on their own line and act on it. Departments typically see the effect first in reporting behaviour: people stop and ask instead of working around a problem.