Auditing and Gap analysis, CAPA:

Our team perform various types of in-depth audits like gap analysis, SWOT analysis, technical due diligence, etc to verify compliance of your prevailing quality systems and operations to the current GMP guidelines and their expectations. We closely evaluate them in the planning, deployment and verification of corrective and preventive action plans (CAPAs) that are scientifically justified, compliant and sustainable. We offer hand-holding support to your team to prepare the organization for different regulatory audits; viz. USFDA, MHRA, PIC/S, WHO, ANVIZA, TGA, ISO quality systems.

GMP auditing of Facility for compliance verification:

.   USFDA 6-system, CFR compliance;

.   European regulation, EudraLex compliance;

.   ICH, PIC/S and WHO requirement verification;

.   MCA, TGA, ANVIZA, ASEAN and BRIC regulation compliance;

.   ISO17025 (NABL), ISO13485 2016(CE mark), ISO 9001(2015) quality system compliance;

.   Investigation for the Impact, Root caused, Failure mode, Hazards, etc

.   Competency mapping of the SMEs;

.   MOCK audits, Unit operations;

.   Training and counselling;

.   Readiness of the key auditable documents;

.   Proof book verification;

.   Monitoring of the First-time-readiness and All-time-readiness.