A multinational pharmaceutical company required assistance to Validate equipment used in the manufacturing of an Active Pharmaceutical Ingredient (API). The facility was recently refitted to handle the manufacturing of a new API for global supply.
SeerPharma was approached to provide experienced Contract resources that could:
- Execute IQ/OQ protocols of their newly fitted out API facility and
- Review existing protocols and documentation
The SeerPharma validation contractors worked alongside the client’s Operations and Quality team over four (4) months, working shifts and weekends, to assist in getting the facility to a state where it would be ready for final batch release.
Contact us should you require contract resources to assist with Validation activities at your facility.
This post comes from our October 2017 Journal. You may also be interested in:
- Medical Device and Pharmaceutical QA Contract Resources
- GMP Facility Design Services and Equipment Qualification
- GMP Validation for API Manufacturer
- TGA GMP License Assistance for a New GMP Facility
