Know-How and Experience
Authorised by Italian Medicines Agency to manufacture active pharmaceutical ingredients (APIs) and medicinal products for human use , Laboratori Baldacci S.p.A manufacturing plant, located in Pisa, covers about a 11,000 square metres area. It is composed of separate buildings, designed for specific production and logistic activities :
API’s production by chemical synthesis
Premises dedicated to the production of the API Lactobacillus rhamnosus and the vaginal tablets which contain it.
Production, including primary and secondary packaging, of oral solid pharmaceuticals ( tablets, powders, hard capsules) and liquids for internal use
Quality control premises ( 330 square metres)
Warehouses ( 1600 square metres)
in addition to administrative and technical support premises.
Thanks to the know-how gained during years of production and to the investments made in production development, Laboratori Baldacci S.p.A is able to assure high quality APIs and drug products, manufactured in full compliance with Good Manufacturing Practices
Certificati GMP Officina farmaceutica Laboratori Baldacci S.p.A:
– raw materials pharmacologically active – Download Laboratori Baldacci GMP certificate 2012
– medicines – Download Laboratori Baldacci GMP certificate 2012
In order to achieve such a goal, the Company relies on well-established Quality Assurance System and Quality Control Laboratories, both chemical and microbiological , managed by highly qualified and specialized personnel. This staff, under the Qualified Person supervision, verifies that each production procedure and each activity production-related is performed in compliance to cGMP :
– monitoring, analysing and recording both production activities and support services
– checking the conformity of starting materials, intermediates, packaging materials and finished products
on the basis of a Quality System set up on Standard Operating Procedures, validations, suppliers and equipments qualifications, changes and deviations management, quality annual reviews , personnel training and self audits.