Good Manufacturing Practices

Quality assurance involves all aspects that influence the quality of the medicinal product, ensuring that all medicinal products are produced in accordance with Good Manufacturing Practices (GMP) and legislation in force and that they reach the final consumer in compliance with all their quality, safety and efficacy requirements.

 

Manufacturing

• Preparation of the Master File Site.
• Preparation and elaboration of Pharmaceutical Documentation for manufacturing processes and auxiliary systems.
• Equipment qualification. Execution of QI, QO and QD protocols and reports.
• Product Quality Review, according to European Guidelines. We have our own team for on-site data collection.
• Validations of manufacturing, maintenance, cleaning processes and analytical methods.

 

Quality control

• Development of Analytical Methods.
• Validation of Analytical Methods.

 

Galenic development

• Solid, semi-solid, liquid and sterile pharmaceutical forms.
• Pilot lots and respective pre-formulation studies.