Services

Commissioning and Qualification

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:

C&Q/ Validation Master Plans

We come up with fine-tuned Master Plans, that are well-suited to your specific C & Q needs, and ensure quality without compromising efficiency

Facility and Equipment Qualification

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

Risk Assessments

We offer comprehensive risk assessment, help you to prioritize risks and establish a most-to-least critical importance ranking followed by designing your validation plan based on these.

Traceability Matrices

We ensure the traceabilty of all cGMP aspects of the URS by documented testing at various stages of the qualification lifecycle

IQ, OQ and PQ Protocol Generations / Reviews

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

Analytical Method Validation

We can help you assert the quality, reliability and consistency of your analytical methods

FAT / SAT Protocol Reviews

We review the vendors FAT/SAT protocols for you and can also perform FAT where required

Design Reviews

Our experts will analyze your process and system design, and help you eliminate any weak links in the design

Projects

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.