We provide services for designing & commissioning of old and new manufacturing facilities complying national and international cGMP guidelines for followings:
We design new manufacturing facilities cost effectively meeting US-FDA, EU-GMP, PIC/s, WHO & SCHEDULE M guidelines. We design technical layouts e.g Civil layout, Door & Window layout, Man & Material movement layout, HVAC zoning layout, Pressure differential layout, Machine & Utility positioning layout, Water system including user points layout, Drain layout & Fire hydrant as per requirement.
BOQs of HVAC systems, Purified/WFI system & Compressed air system are reviewed and approved by us to ensure compliance as per regulatory guidelines.
Technical specifications of all equipment, instrument and utilities are reviewed by us to ensure that all machineries are purchased as per approved URS.
We have expertise in upgrading & re-designing old facilities as per current good manufacturing practices meeting US-FDA, EU-GMP, PIC/s, WHO & SCHEDULE M guidelines. We do gap analysis of the facility in first phase and prepare layouts accordingly.
We ensure that with minimum civil changes, facility is upgraded as per cGMP guidelines and meets national and international regularity requirements.
We work as an associate with our client and help/guide/assist them during commissioning or installation of the machineries.