650 SQM built up area with well-defined segregated areas for cell based assays, microbiology, raw and packing material testing
Fully qualified and 21CFR part 11 compliant with a dedicated area for receipt and storage of samples for analysis
Fully validated methods for performing purity, identity and safety analysis using fully validated methods
Capable of performing stability studies as per ICH guidelines
Separate microbiology section to perform microbiological testing such as BET, bioburden and sterility analysis of different samples in addition to growth promotion tests etc.
The Quality control lab has the following capabilities:
1900L Cold room, humidity chambers (25°C and 40°C), Deep freezers (-20°C±5), Ultra low freezer (-80°C±10) with validated data logging system
Dedicated chambers for storage of reference standards, control and retention samples.
Automated TOC, IR, Autotitrator for water and Raw material analysis.
Two 15000 L walk in incubators in addition to 7 incubators with different temperature ranges
