Sectors
Part of WAMCA Global
Connecting industries, expertise and opportunity across global manufacturing.
Sector certification
Certificates help prove a company’s quality, safety, and reliability to both customers and partners. Certificates most relevant to pharmaceutical and health technology manufacturers include:
01
ISO 9001
A quality management system applied across pharmaceutical formulation and medical-device production lines.
02
ISO 14001
An environmental management system covering solvent handling and manufacturing waste streams in pharma production.
03
ISO 45001
Occupational health and safety management for staff handling active ingredients and clinical-grade materials.
04
GMP
Good Manufacturing Practice, the baseline standard for consistent, quality-controlled pharmaceutical production.
05
ISO 13485
A quality management system specific to medical devices and their manufacture throughout.
06
CE marking
Indicates that the product complies with EU safety and quality requirements, required for many medical devices sold into the EU.
07
GDP
Good Distribution Practice, covering the safe storage and transport of pharmaceutical products.
The regulators
Regulators and inspectorates govern this sector. We track their requirements and brief members on what changes.
