Quality assurance

Based on one hundred years of Pharmaceutical Experience, Menarini Biotech offers a Quality Management System which complies with the GMP for the manufacturing of Biological Active Drug Substances) and for the Quality Control of Finished Product (e.g. Drug Product) samples from third-party.  

Menarini Biotech’s Quality System is intended to ensure the reliability, efficacy and security of products developed, produced and released by the company.

Menarini Biotech’s Quality System is risk-assessment based and covers the following areas:

• Deviation and Quality Event

• Change Control

• Training

• Self-inspection

• Computer System Validation

• Documentation

• Materials management

• Equipment, utilities and facilities

• Manufacturing processes

• Process Development

The Company is committed to manufacture and distribute high quality products through a quality system, which permits that each and every activity complies with the applicable rules and policies or practices required to maintain the highest level of confidence. The QA is involved in all functions related to product quality such as:

• Design of premises and relevant utilities
• Selection of manufacturing equipment
• Drafting of Standard Operating Procedures
• Verification, of the manufacturing procedures, against manufacturing authorization
• Verification of the implementation of current Good Manufacturing Practices