In addition to GMP certification by the national health authority INFARMED, the regulatory authorities of the following countries have already certified our production unit: United Arab Emirates, Cambodia, Ivory Coast, Ethiopia, Haiti, Yemen, Iran, Libya, Ukraine and Vietnam.
In strict compliance with and dedication to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), we meet the highest standards of quality in manufacturing and product control, always aiming for an increased degree of efficiency and delivering services of excellence.
Our Quality Management System (QMS) is based on continuous improvement, permeating all the activities that are carried out in our facilities and that may directly or indirectly affect the quality of the products. The QMS is seen as a strategic priority that reflects the company's vision and mission.
- Manufacturing transfer
- Validation of manufacturing processes
- Product Quality Review
- Determination of health based-exposure limits (HBEL) of various APIs/products and definition of cleaning limits
- Various Quality Risk Assessments
Quality Control (QC) department is responsible for the sampling of intermediate and finished products, in accordance with the procedures defined by the company, by conducting physical, chemical and microbiological tests. The QC department is also responsible for the in-process control tests performed in the production and packaging areas, continuously monitoring the manufacturing process.
In addition to routine analyses, the Quality Control Department performs the following additional services.
- Analytical transfer
- On Going and ICH Stability Tests
- Analysis of Finished Products manufactured outside Farmalabor, for release in the EU
- Various analytical services
The Industrial Unit is authorized by the regulatory authority to perform batch release, as long as:
- Products are prepared according to Good Manufacturing Practices (GMP) and analyses are conducted in accordance with Good Laboratory Practices (GLP)
- Each batch of pharmaceutical product is produced and tested as defined in the respective Marketing Authorisation (MA)
- If a batch has been produced outside the EU, each imported batch is tested as defined in the Registration dossier
- Products are manufactured in compliance with established regulations in order to obtain the required quality.
- Partial batch certification
- Full Batch Certification/Release