[ GXP DISCIPLINES ]

Every GxP discipline, decoded.

GxP is not one rulebook but a family of disciplines, each governing a different part of the regulated product lifecycle. SPEQ decodes each one — what it governs, where it fails, and the standards that define it.

CORE DISCIPLINES

The six good-practice disciplines that govern how regulated product is developed, made, tested, and distributed.

GMP

Good Manufacturing Practice

Manufacturing, sterile/aseptic processing, contamination control, and product quality.

60 standards decodedDecode GMP →

GCP

Good Clinical Practice

Clinical trial conduct, subject protection, and data credibility.

7 standards decodedDecode GCP →

GLP

Good Laboratory Practice

Non-clinical safety studies and their reconstructability.

5 standards decodedDecode GLP →

GDP

Good Distribution Practice

Supply-chain integrity, storage, and cold-chain control.

6 standards decodedDecode GDP →

GVP

Good Pharmacovigilance Practice

Safety surveillance, signal management, and adverse-event reporting.

5 standards decodedDecode GVP →

GEP

Good Engineering Practice

Facility, equipment, and utility design; commissioning and qualification; risk- and science-based verification.

4 standards decodedDecode GEP →

CROSS-CUTTING

The practice areas that run through every discipline — data integrity, clinical-lab analysis, computerised systems, and the quality system that ties them together.

GDocP