- Pharmaceutical laboratories, manufacturers and importers, must have a technical report in accordance with Spanish Royal Decree 824/2010 of 25 June.
- The regulatory authorities carry out inspections of Good Manufacturing Practices and Good Distribution Practices, so the Quality System documentation must be kept up to date.
- An adequate documentation constitutes a fundamental part of the Quality Assurance system and is fundamental to work in compliance with the requirements of the GMP/GDP
- At Azierta, we review, develop and implement standard operating procedures (SOPs) in a clear and concise manner on the GMP-related activities of pharmaceutical laboratories. In addition, we provide support in the development and revision of the Technical Report and the Quality Manual of the plants.
Review, development and implementation of documentation Support
- Standard Operating Procedures (SOPs)
- Quality Manual
- Technical report
- Preparation of the document
- Review of the document
- Approval of the document
At Azierta, we are specialists in GMP quality systems, and we guarantee their effectiveness, tracking and implementation.