Learning resources
The sources we rely on ourselves. We link to the official pages only; paid guides must be bought from their publishers.
Where I start: ISPE
"In twenty years of designing and building pharmaceutical plants, ISPE has been my most useful source. When I have an engineering question about sterile production, water, HVAC or qualification, I open an ISPE guide first. For computer systems, and now AI, I start with GAMP 5. I keep the full ISPE engineering library and still use it."
Veiko SalusteEngineering guidance for sterile products, water and steam, HVAC, commissioning and qualification.
Computerised systems, risk-based validation and the basis for using AI in GMP.
- ISPE TrainingPaid
Courses on the same topics, many online.
Regulations and their interpretation
Every chapter and annex our pages cite, with the paragraphs to read: GMP references →
The rules themselves: chapters, annexes (incl. Annex 1, 11, 15, 16) and the drafts out for consultation. Always the first stop.
The official interpretation of EudraLex. Inspectors quote it.
The GMP guide and the Aide-Memoires: inspectors' own checklists for utilities, data integrity and more.
Q9(R1) risk management and Q10 quality system, the backbone of any modern QMS; Q7 for active substances.
Clear, free and harmonised with EU GMP. Good material for new staff.
The US view. Warning letters are the best free record of what goes wrong in practice.
- EudraGMDPFree
Check a supplier's GMP certificate or non-compliance report before you qualify it.
Engineering and aseptic practice
The aseptic processing library: sterilisation, environmental monitoring, process simulation, contamination control.
Methods and monographs: sterility, endotoxins, particles, water.
Courses
Hands-on aseptic processing courses in a real cleanroom.
- ECA AcademyPartly free
European GMP courses and a free news service on EU changes.
And our own courses on using AI in GMP.
The authorities
Links to the agencies that inspect pharma in the EU, Baltics and Nordics, and their public databases: Who inspects pharma →
A note on copyright
ISPE, PDA and pharmacopoeia texts are licensed. We use them as knowledge, never as content we copy, share or feed into an AI system. Free official texts (EudraLex, EMA, PIC/S, ICH, WHO, FDA) are what we use to test our tools.