GMP fundamentals
Principles, responsibilities, hygiene and documentation: the common foundation for all operators.
25 minBeginner
Topic hub · GMP
Online GMP training & good manufacturing practices, ready to deploy.
The good-manufacturing-practices hub: GMP, sterile Annex 1 and data integrity. Micro-learning modules that are clear on the first read, aligned with inspector expectations, with an auditable certificate.
Why train on GMP
GMP isn't read, it's executed at the workstation.
Good manufacturing practices — GMP — govern every step of making a medicine: hygiene, gowning, process operation, documentation, batch management. On the floor, the challenge isn't knowing the standard — it's applying it the same way, by every operator, on every shift.
Effective online GMP training must therefore drill down to the exact move expected at the workstation, not stay at the level of principle. That's what Academy does: short, visual micro-learning programs, segmented by role, that turn a regulatory requirement into a daily reflex.
Three subjects structure this hub: GMP fundamentals, sterile production (Annex 1) and data integrity — the three areas where inspections concentrate the most findings.
100%
of staff must be trained for their activities, with a suitable level of education, training and experience — a GMP requirement, not an option.
Hub training
The GMP programs.
Standalone modules or grouped into programs, from fundamentals to sterile expertise.
Behavior in the production area
Gowning, flows, cross-contamination: the right moves in a controlled-atmosphere zone.
20 minBeginner
Annex 1: sterile production
Contamination control strategy (CCS), grades A to D, aseptic behavior.
35 minAdvanced
Aseptic technique & interventions in the clean zone
Interventions under laminar flow, media fill simulation, environmental alert management.
30 minAdvanced
Data integrity & ALCOA+ principles
Attributable, legible, contemporaneous, original, accurate: securing data throughout its life.
22 minIntermediate
Good documentation practices (GDocP)
Filling in a batch record, correcting an error, signing: the reflexes that avoid findings.
18 minIntermediate
Three subjects, one hub
Where inspections concentrate their findings.
GMP fundamentals
The regulatory foundation and the daily moves: hygiene, documentation, process operation, batch management.
Annex 1 — sterile production
Aseptic behavior and the contamination control strategy, the critical point of any sterile inspection.
Data integrity
Data integrity and good documentation practices, at the heart of what the authorities expect.
FAQ
Your questions about GMP training.
Everything you need to know before deploying your programs.
None in substance: GMP (good manufacturing practices) and cGMP (current good manufacturing practices) refer to the same set of requirements applicable to the manufacture of medicines, "current" simply emphasizing the up-to-date state of the art. Our modules cover both terminologies.
Anyone whose activity has an impact on product quality: production, QA, QC, maintenance, logistics. The regulation requires that 100% of staff be trained for their activities, with initial and ongoing training (21 CFR 211.25).
Yes. Each module ends with a quiz and issues a traceable, auditable certificate that stands up to inspectors, with a complete completion history — an audit-ready setup, integrable with your LMS via SCORM or xAPI.
Yes. A dedicated program covers the contamination control strategy (CCS), cleanliness grades, aseptic behavior and interventions in a controlled-atmosphere zone, at the level of the move expected at the workstation.
In a matter of days. The modules are ready to use: you choose your programs, assign them, and your teams learn. No content production to wait for, unlike in-house development.
Explore our GMP catalog.
The full list of GMP, Annex 1 and data integrity modules, with durations and levels.