Production
The laboratory
The pharmaceutical plant of Laboratori Baldacci S.p.A, located in Pisa, extends over a total area of approximately 11,000 m², which includes 1500 m² of production area and 330 m² of quality control area. The plant is regularly inspected by the Italian Medicines Agency and has a consolidated Quality Assurance and Chemical and Microbiological Quality Control Service, managed by highly specialized and qualified personnel who, under the supervision of the Qualified Person, check that each production procedure and any activity related to it takes place in accordance with GMP.
Controls and Quality
Laboratori Baldacci S.p.A is authorized by the Italian Medicines Agency for the production of active pharmaceutical ingredients (API) and medicines, in particular for the production of the following pharmaceutical forms:
- Hard capsules
- Tablets (both oral and vaginal)
- Liquids for internal use
To achieve this objective, the monitoring of production conditions and support services is ensured, the conformity control of intermediates, packaging materials and finished products is ensured, on the basis of Standard Operating Procedures, validations, qualification of suppliers and of equipment, management of changes and deviations, “annual quality review”, staff training and self-inspections.
Production area
Thanks to the know-how acquired over years of production activity and the investments made for the development of production processes within the company, Laboratori Baldacci S.p.A is able to guarantee the production of quality APIs and medicines.
The production area is made up of separate buildings, dedicated to specific activities:
- Warehouses for raw materials, printed materials, packaging materials
- Weighing rooms
- API production area
- Production and primary and secondary packaging
of oral solid pharmaceutical forms (tablets, powders, hard capsules) and liquids for internal use
