Quality Assurance

Quality assurance involves all aspects that influence the quality of the medicinal product, ensuring that all medicines are produced according to good manufacturing practice (GMP) and legislation in force and that they reach the end consumer by complying with all their quality, safety and efficacy requirements.

Objectives:

- Ensure that the administration of the drug to the patient will achieve the desired effect;

- Protect the patient who will administer the drug from possible defects in production, design, storage and instructions for use.

- Ensure that all legal requirements are met

- Provide protection to the organization that manufactures the drug.

 

  • Manufacturing

- Elaboration of Site Master File

- Preparation and elaboration of Pharmaceutical Documentation for manufacturing processes and auxiliary systems.

- Qualification of equipment. Execution of protocols and reports of IQ, QO and QD.

- Product Quality Review, according to European Guidelines. We have our own team, for data collection on site.

- Validation of manufacturing, maintenance, cleaning and analytical methods.

 

  • Quality control

- Development of Analytical Methods.

- Validation of Analytical Methods.

 

  • Galenic development

- Solid, semi-solid, liquid and sterile pharmaceutical forms.

- Pilot batches and respective preformulation studies.