“GCC GMP” is best understood as a family of national requirements with a common foundation rather than a single rulebook. National authorities — such as the Saudi Food and Drug Authority (SFDA) and the UAE’s federal medicines regulator — publish GMP requirements and inspect against them. In practice, these requirements draw heavily on internationally harmonised GMP: the PIC/S and EU GMP guides, including their annexes on computerised systems and sterile manufacturing, and WHO GMP.
For manufacturers inside the region, that means inspections that look much like PIC/S or EU inspections. For manufacturers elsewhere — in India, for example — supplying Gulf markets, product registration typically requires evidence of GMP compliance, and Gulf authorities may inspect overseas manufacturing sites. Either way, the questions are familiar: is the quality system effective, are records complete and attributable, and are computerised systems validated and controlled?
Common expectations across Gulf authorities
- A pharmaceutical quality system with deviations, CAPA, change control and quality risk management.
- Qualified suppliers and controlled starting materials, with quarantine, testing and release.
- Complete batch records, reviewed before release, and laboratory controls that are scientifically sound.
- Data integrity across paper and electronic records, in line with ALCOA+ principles.
- Computerised systems that are validated and controlled — access, audit trails, electronic signatures — in the manner of Annex 11.
- Sterile manufacturing controls in line with the current Annex 1, where applicable.
- Traceability and recall arrangements for every distributed lot.
National requirements and their versions change. Always confirm the current GMP text and any national variations with the authority that inspects your site.
