Sectors
Part of WAMCA Global
Connecting industries, expertise and opportunity across global manufacturing.
Standards Relevant to Pharma & Health Technology
Common standards help pharma and health technology manufacturers avoid errors, build buyer trust, and enter foreign markets. A few carry particular weight across PHTIA's four sub-sectors:
01
GMP (Good Manufacturing Practice)
A mandatory standard for pharmaceutical manufacturing, covering hygiene and safe production practices.
02
ISO 13485
A quality management standard specific to medical devices manufacturing.
03
Lean
A methodology for reducing waste across pharmaceutical and medical-device production lines.
04
Six Sigma
A data-driven standard for minimising defects in pharma and health technology manufacturing.
05
ERP integration standards (e.g. ISA-95)
Reliable data exchange between production planning and order management in a regulated production environment.
06
Industry 4.0 and Smart Manufacturing standards
Frameworks for digital production and data management.
The regulators
Regulators and inspectorates govern this sector. We track their requirements and brief members on what changes.
