Audit Services
Our auditing process involves a comprehensive review based on the current best practices guidelines on different aspects. Our auditors have a strong techno-commercial background, thus providing a practical & feasible way forward. Having hands on experience we can offer support and guidance in the following areas:
Facility & Layout Audit:
Manufacturing areas, utilities, Laboratories, R&D, pilot plant.
Due Diligence Audit:
Establish / verify technical & financial capabilities.
Feasibility audit for clients in India & overseas.
Assessment of sites / systems as per the regulatory guidelines and GMP requirements (USFDA, MHRA, EMEA, TGA, ANVISA, WHO, Health Canada, SDFA, CDSCO and others).
Warehouse Audit (storage, handling & distribution):
Receipt, storage, distribution of raw materials, solvents, engineering items, sampling, Temperature data logging / mapping.
Safety Systems Audit
Health and safety management compliance and controls based on the company’s and statutory requirements.
GMP System (Manufacturing / Quality / Engineering) Audit:
In depth assessment of the current state of compliance, it’s rectifications, remediation measures followed by coaching and training.
Pre Inspection (Regulatory agencies) Audit:
Review to check the compliance to written procedures, identify gaps and have a mitigation plan to improve / improvise the current status and level of preparedness.