As the Pharmaceutical, Biopharmaceutical and Medical Device Industries add new technologies to the marketplace, it is vital that calibration programs are integral to the method development and validation testing used to ensure regulatory compliance and to ensure that the finished products be of the highest caliber.
Regulators take particular care to make certain that the methods and processes used in the industry are reproducible and validated to assure safety and consistency.
Protocol development and validation testing
Recognizing the critical requirement established by Good Manufacturing Practices as it applies to validations of these programs, Gibraltar provides clients with protocol development and validation testing for both microbiological and chemical validations.
These programs, performed according to the requirements outlined in 21 CFR, include:
• Cleaning Validation
• Process Validation
• Method Development
• Method Validation
• Stability Indication
• Method Transfer
Other key capabilities - We travel to your facility
Gibraltar also serves clients in the area of calibration, assuring that their production flow is not compromised by issues concerning their production environment and equipment. We provide:
• Clean Room Air Quality
• Thermal Mapping of Refrigerators, Autoclaves, Freezers, Incubators, etc.
• On-site Technical Service and Calibration
Gibraltar stands ready to assist your company in developing the assurance needed for your systems.
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