GAMP Services follows a quality management system (QMS) which includes standard operating procedures (SOPs), processes and data management, customer feedback and man-material movement with training and traceability records to ensure that we are holding ourselves to the highest level of quality.
GAMP services follow regulatory guidelines such as ISO 14644, cGMP, cGLP, cGxP, cGDP, GAMP 5, 21 CFR Part 11, 21 CFR Part 210 as well as 21 CFR Part 211.
The revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
The ISO14644-1& 2 provides a total validation approach related to Cleanrooms and associated controlled environments ISO 14644-1 annexure B provides test methods for designated classification of airborne particulate cleanliness and for characterizing the performance of cleanrooms and clean zones.
ISO 14644-3 is consisting of the following tests as part of HVAC/Cleanroom validation.
