GMP GDP Support – Quality & Vigilance

GMP/GDP Support Services

At Quality and Vigilance, we collaborate closely with sponsors to understand their audit requirements, set priorities, and align with project timelines. We offer comprehensive end-to-end support for clinical audits and regulatory inspection readiness.

Audits of GMP manufacturing and Test sites

Drug Product Manufacturers (Contract Manufacturing Organizations - CMOs)
Medical Device Manufacturers
Primary Packaging Sites (Fill-Finish Facilities)
Secondary Packaging Facilities
Contract Testing Laboratories (Analytical and Microbiological Testing)

Audits of vendors/suppliers

Raw Material Suppliers
Primary Packaging Material Suppliers
Secondary Packaging Material Suppliers
Contract Storage Facilities
Distributors and Warehouse Facilities
Printed Packaging and Labelling Material Providers
Electronic Quality Management System (eQMS) Vendors

Inspection Readiness

Mock Pre-Certification Inspections
Self-Inspection and Internal Audits
Quality System Audits (21 CFR Part 210/211, ICH, EMA)
Risk Identification and Mitigation Planning
Pre-Inspection Gap Analyses

Quality Investigations and CAPA

Coordinate and act with the sites on quality issues, challenges, and queries from operational areas.
Evaluate concerns on risk-based approach and investigate issues in a methodical way by utilising investigational tools and techniques to determine the root cause and implement Corrective and Preventive Action Plan (CAPA) of the issue.
We are here to help and support your site to improvise the inspection outcome to back on their feet. Our experts will work with you to address any issues highlighted in the FDA issued 483 and any warning letter observations.