We have adopted the risk-based approach to qualification, based on ISPE good practice guide and ICH Q9. we follow a scientific methodology and are focused on process and product understanding, targeted to achieving suitability for intended use. We offer the following services:
In keeping with industry and regulatory standards, our qualification protocols are designed by experts. We cover the entire lifecycle (URS/FRS/ DS & DQ/IQ/OQ/PQ/reports) in our qualifications or tailor the program to just you needs, for e.g just to a particular aspect like the OQ
Installation and operational qualification - we ensure that systems adhere to user requirements and manufacturer’s approved specification and that recommendations of supplier are considered during the IQ/OQ process
Our experts will analyze your process and system design, and help you eliminate any weak links in the design
Biopharmax India Pvt. Ltd.
Biopharmax is an EPC organization providing design & construction services for manufacturing facilities. Together with Biopharmax, VSG has handled some high profile projects for major companies in India like Abbott India Ltd. and Wockhardt Ltd.