cGMP Audits :

cGMP audits involving complete supply chains, all areas of manufacturing and all departments of the company

Our cGMP audits include mapping of Good Behavioural Practices (GBP) ensuring GMP and QMS compliance from lowest level worker to the top level management

Chimera Gentec contributes to the auditing process for complete compliance with cGMP as per various regulatory standards by review of Documents and Data from Integrity Point of View, Inspection readiness/ Master Plans (FDA, EU, ANVISA, CFDA, PMDA, TGA , WHO etc) through Mock Inspections/ Assistance during inspections/post-inspection/ due diligence (Quality) of product and facility

Chimera Gentec provide technical support to incorporate continuous improvement elements in QMS. It provides support in establishing feedback loops from bottom to top and top to bottom in supply chains and manufacturing

A few areas include:

Start-up of new facilities by ensuring product licensing

Self-Inspections/Internal Audits including Manufacturing Process, Testing Laboratories, Warehouse, Documentation Management, and Compliance

External Audits, Including Contract Manufacturing Sites and Vendor/Raw Material Suppliers

Clinical Trial site preparation and conduction of Clinical Trials through GCP and GLP

Audits of CROs for BE/BA/ for Pre-clinical and Clinical Trials

Review of validation, protocol & reports and production records

Audit/Review, Standard Operating Procedures (SOPs), Analytical Methods, and Specifications

Preparations for WHO-PQ, USFDA, European Audits and other mature regulatory agencies