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ISO Certification for Life-Sciences Companies: 13485, 9001 and 27001
The three ISO standards that matter most in life sciences — and what the 2026 ISO 9001 revision means for companies certified today.
GxP Training Mandates: What EU GMP and GDP Actually Require
Training is a legal obligation under EU GMP and GDP. What the rules require and how to build a training system that survives inspection.
Serialisation and the Falsified Medicines Directive in Greece
Every prescription pack in Europe now carries a unique code and a tamper-evident seal. For companies supplying Greece, the country’s late arrival to this system[…]
The Qualified Person: The Signature That Releases a Batch
No batch of medicine reaches a patient in the EU until one named individual takes personal legal responsibility for it. Understanding the Qualified Person’s role[…]
Serialisation και την Οδηγία για τα Ψευδεπίγραφα Φάρμακα: Κρατώντας την Αλυσίδα Εφοδιασμού Ασφαλής
Since February 2019, almost every prescription medicine pack in the EU has carried two safety features — a unique 2D barcode and an anti-tampering device[…]
The Qualified Person and Batch Release: The Last Line of Defence
No medicinal product can be placed on the EU market until a Qualified Person (QP) has certified the batch. It is one of the most[…]
Good Distribution Practice: What the Guidelines Actually Require
A medicine can be manufactured perfectly and still reach the patient compromised. Good Distribution Practice governs everything that happens in between — and it is[…]
GMP Inspection Readiness: Annex 1 and the Contamination Control Strategy
The revised Annex 1 did more than tighten sterile manufacturing rules — it made the Contamination Control Strategy the organising document of your entire quality[…]