Its aim is to guarantee the quality of the products manufactured in Seid by means of process validations, cleaning validations, management and checking of the documentation, staff training on GMP, periodic internal inspections of all the sections in order to assure the compliance with normatives, management of CAPA (Corrective Action Preventive Action), suppliers certification, external audits, etc.
It is responsible for monitoring the product quality through:
- Sampling of raw materials and products
- Physico-chemical and pharmaco-technical analysis
- Microbiological analysis
- Validation of analytical methods/processes
- Analytical transfer
- Stability testing long term and accelerated conditions
- Dissolution profiles
The joint work between both Departments leads to products according to the current specifications on efficacy, safety and quality.
Certificate of Good Manufacturing Practices compliance. The authorised operations include manufacturing, packaging, quality control, batch release and certification, storage and distribution.
Authorised for manufacturing operations of human and veterinary medicinal products and investigational medicinal products:
- Coated tablets
Liquids for internal and external use:
- Solutions for external application
- Oral solutions and suspensions
Hormonal semi-solids (dedicated facilities)
It is responsible for the management and checking of regulatory documentation:
- Preparation of the regulatory dossiers in NeeS and eCTD formats
- Regulatory support to obtain the Marketing Authorization of the product (responses to the questions of the National Competent Authorities)
- Post-approval regulatory support (variations, post-authorization studies, etc.)
Seid complies with the current guidelines on this subject and has a complete system of Pharmacovigilance in order to guarantee the safety of its products.