The JHP Validation Program provides documented evidence that facilities, equipment, systems, and processes perform according to design specifications and regulatory requirements for the manufacturing, laboratory testing, release, and distribution of products manufactured at JHP Pharmaceuticals. The program is designed to demonstrate quality features built into the facility, systems, and processes; and to ensure that they comply with international, federal, corporate, state, and local regulations.
- Aseptic Process Validation (Media Fills)
- Cleaning Validation
- Computer Validation
- Equipment Qualification
- Product / Process Validation
- Project Management
- Project Master Plans
- Protocol Writing and Summary Reports
- Sterilization Validation
- Utilities Qualification
Additionally, our Change Control Program provides a mechanism to ensure that processes and support systems remain in a state of validation. JHP utilizes internal resources for validation, but augments with external contractors where necessary.