Policy
Scope
Quality is to be applied by every employee to every aspect of our activities daily to ensure
- Safety
- Quality
- Regulatory Compliance
- Sustainability
This policy and associated procedures apply to all directors, staff, and contractors working for the company.
Policy
The Quality Policy is executed under the guidance of the Quality Management System (QMS) and its associated policies and procedures, in conjunction with the Haim Pharma Risk Management Plan.
Legislative Requirements
Haim Pharma Group Ltd. Policies and Procedures are written to comply with or to provide guidance to the standards listed below.
- Eudralex Volumes 1-10 EU Legislation & Guidelines for Medicinal products
- European Union Good Manufacturing Practices (EU GMP)
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Standards
- United States Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Parts 11, 210 & 211
- World Health Organisation (WHO) GMPs for Pharmaceutical products
- European Union Good Manufacturing Practices (EU GMP)
- Good Manufacturing Practices (cGMP),
- Good Distribution Practice (GDP)
END OF POLICY