Every detail has a precise, specific and decisive value, especially within complex processes aimed at determining whether a product complies with all the standards of quality and safety.
Improving processes, using data to implement digital ones, focusing on innovation, modernising production, and applying a lifecycle approach that allows accurate control during all procedures are actions that must be managed with the utmost attention and skill.
The skills we have acquired by developing and implementing qualification protocols valid for the activities carried out in the pharmaceutical manufacturing plants, Process Validation, Equipment Validation, Utilities Validation, Computer System Validation, Cleaning Validation, Analytical Method Validation, in accordance with the GMP (Good Manufacturing Practice), ICHQ14 and GAMP (Good Automated Manufacturing Practice) guidelines, allow us to be operational in every sector we deal with.
We draw up and carry out qualification protocols valid for all processes and activities.
SERVICES OFFERED IN THE VALIDATION AREA
- cGMP Computer Control System Compliance and Data Integrity;
- CSV (Computer System Validation);
- Development and implementation of qualification protocols;
- Process Validations;
- FMEA;
- Support for Process Analytical Technology (PAT);
- Implementation of the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) protocols and Witnessing of Supplier Testing Activities (FAT/SAT support);
- cGMP compliance of critical utilities;
- cGMP Compliance of cleaning validation of materials and excipients;
- cGMP Conformity of packaging processes;
- cGMP Compliance of Sterile and Non-Sterile Quality Control and Validation Laboratories;
- Validation Master Plan;
- Quality Risk Management;
- Media Fill Protocols;
- Commissioning Plan;
- Packaging Process Validation;
- Transport Validation;
- Shipping validation;
- Temperature mapping;
- Drawing up documents and SOPs;
- Audit of system suppliers;
- Support for validation periodic review.
