Definition
The state of being able to host a regulatory inspection at short notice: current documentation, traceable records, trained staff, closed CAPAs, and a rehearsed front-room and back-room process for handling requests during the inspection.
Related terms
GMP
The set of rules ensuring medicinal products are consistently produced and controlled to the quality standards required by their intended use and marketing authorisation. In Europe it is set out in EudraLex Volume 4; in the US in 21 CFR Parts 210 and 211.
GDP
The quality standard for the storage, transport, and distribution of medicinal products. It covers wholesale licensing, qualified personnel, temperature control and mapping, supplier and customer qualification, and the handling of returns and falsified medicines.
GLP
The quality system governing how non-clinical safety studies are planned, performed, recorded, reported, and archived, so that regulators can rely on the data submitted in a marketing application.
ISO 13485
The international standard for quality management systems specific to medical devices. Certification is the practical route to demonstrating the QMS requirements of MDR Article 10 and IVDR Article 10, and is expected by most notified bodies and customers.
QMS
The documented set of processes, responsibilities, and records through which an organisation plans, controls, and improves product quality and regulatory compliance, from design and supplier control through production, release, complaints, and CAPA.
CAPA
The quality process for investigating a problem, correcting it, addressing its root cause so it does not recur, and preventing similar issues elsewhere. Effectiveness checks close the loop, and CAPA records are a standard focus of inspections and audits.
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