Remediated the Notice of Suspension served by WHO Geneva, with project management and respective documentation.

As part of remediation, carried out a gap assessment and the remediation of the controls in the ERP system and the Computer System validation of the Progen ERP system that was being used.

Gap Analysis and Upgradation of system and procedures as per USFDA Dietary supplements guideline requirements as per CFR 21 Part 111 “Current Good Manufacturing Practices in manufacturing, packaging, holding ,and labelling of Dietary Supplements” and Food safety requirements as per CFR 21 Part 117 “Good Manufacturing Practices , Hazard Analysis, Risk Based Preventive controls for Human Food”.

As part of upgradation, carried out a gap assessment and the remediation of the SAP system (SAP EHP 6.0 ) that was being used for the business process, with respect to the process and the controls available.

Gap Analysis and cGMP systems and Procedures enhancement as per PIC/S Guidelines (PIC/S guide to PE-010-04-Good Practices for the preparation of medicinal products in healthcare establishments requirements)

Provided cGMP support and guidance for establishment of an EU GMP Facility

Gap analysis of Quality Control instruments Qualifications, Calibrations and CFR 21 Part 11 assessment.

Gap Analysis of the SAP EHP 8.0 system for end to end business process implementation and controls.

Implementation of Controlled Issuance of GMP documents from SAP EHP 8.0 with Computer System validation : Status : In-progress

Implementation of Document Management System from SAP EHP 8.0 with Computer System validation : Status : Next Planned

Implementation of Quality Management System from SAP EHP 8.0 with Computer System validation : Status : Next Planned

Market Complaints Remediation : Investigation, Root cause analysis , Corrective and Preventive actions and remediation of Market complaints : Status : In – Progress

Gap Analysis and Implementation of Food Safety Management System as per ISO 22000 latest version : Status : In – Progress