The transition from R&D to GMP does not need to represent a conflict between innovation and compliance. The most successful organisations recognise that quality systems support scientific progress.
GMP does not begin at a single identifiable moment. It begins as soon as controlled processes and regulated decision-making become necessary to ensure product quality and patient safety.
Evidence and data integrity expectations evolve progressively across GLP, GCP, and GMP environments, reflecting the increasing regulatory and patient impact of the data being generated.
Regulatory transparency in Good Manufacturing Practice (GMP) oversight is entering a period of structural change, driven by increasing expectations from regulators, industry stakeholders, and the broader healthcare ecosystem.