GMP Audits

Our team has experience and in-depth knowledge of the various domestic and international regulations required to ensure cGMP compliance. Some of our specific services are:

Facility Audit

Inspection of facilities, equipment and laboratory space
Documentation review for GMP support and compliance
Review of IQ OQ and PQ documentation of process equipment’s
Review Quality management Systems, including associated CGMP documentation and internal SOPs
Vendor Certification assessment
Analytical method validation
Assess Corrective and Preventive Action (CAPA)
Review Data Integrity to meet cGMP compliance

GMP Quality Systems

Evaluate internal SOPs, batch records, specifications, methods, change control
Assess validation of analytical and microbiological test methods.
Review process validation and cleaning verification

Vendor Audit

Audit contract facilities for qualification of manufacturing, packaging and distribution.
Audit API, raw material and packaging component manufacturers and suppliers.
Assess vendor structure and operating procedures
Evaluate Quality Systems and ensure cGMP compliance

FDA and International Regulatory Authority Inspection Readiness

Ensure manufacturing facilities meet the requirements for a regulatory inspection
Evaluate site personnel readiness for pre-approval inspection by the FDA or other international regulatory agencies.
Assess manufacturing and control documentation and test methods