Designing building and qualifying GMP temperature-controlled facilities for pharmaceutical products requires knowledge and understanding of the whole process, qualification, legal and risk requirements.
GCCS are specialists in the whole process from initial designs to GMP qualifications and thermal mapping to complete all DQ, IQ, OQ, and PQ documentation and reports.
These are all critical steps in the process, as these areas are a huge investment for a company and are best done right the first time. These areas are designed and validated to meet GDP, and CFR 21 Part 11 standards.
GCCS design and qualification services and documentation for new GMP temperature-controlled facilities have achieved A1 rating at first inspections.
Do you have continuous temperature excursions false alarms out of specification temperatures and continuously completed CAPAs?
GCCS have repaired and corrected hundreds of temperatures-controlled areas in the past 18 years all over the world, with their technical team rectifying the equipment process and operation ensuring temperatures to operate within specification.
For pre-existing storage areas, GCCS will conduct an assessment, provide an inspection and evaluation report and recommended changes to identify and mitigate risks, and GMP findings at inspections and audits or cold chain breaches in the worst-case scenario.
Find out more about our design services here.