We can offer the following expertise:
· Helping manufacturers through to international regulatory approvals, especially EU GMP and USFDA
· Qualification and Validation of facilities, equipment and methods
· Supplier QA development and management
· Troubleshooting to identify root causes
· Facility Design (Quality requirements)
· Design in realistic quality standards at the earliest stage possible. This saves great time and expenditure correcting quality issues late in the project.
· Project management skills
· How often do your projects (new facilities, laboratories, upgrading equipment etc.) meet your planned completion dates? Very often this is due to poor project planning and monitoring.
· Continuous improvement programs
· Key Performance Indicators (KPIs)
· Supplier databases
· Auditing
· We can perform detailed audits of your sites (in preparation for Regulatory inspections), of your suppliers (if you have limited resource or expertise) these can often be combined with other regular trips to distant continents for economy
· Person in place (PIP) in manufacturing facilities
· What does EXCIPACT mean for you?
· Sterile manufacturing and water systems
· Qualification and Validation of facilities, equipment and methods
· Supplier QA development and management
· Troubleshooting to identify root causes
· Facility Design (Quality requirements)
· Design in realistic quality standards at the earliest stage possible. This saves great time and expenditure correcting quality issues late in the project.
· Project management skills
· How often do your projects (new facilities, laboratories, upgrading equipment etc.) meet your planned completion dates? Very often this is due to poor project planning and monitoring.
· Continuous improvement programs
· Key Performance Indicators (KPIs)
· Supplier databases
· Auditing
· We can perform detailed audits of your sites (in preparation for Regulatory inspections), of your suppliers (if you have limited resource or expertise) these can often be combined with other regular trips to distant continents for economy
· Person in place (PIP) in manufacturing facilities
· What does EXCIPACT mean for you?
· Sterile manufacturing and water systems