THIRD PARTY AUDITS

Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products.

Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10.

PDCA Plan Do Check Act.Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor’s assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.

audit_checklistQualified Person (QP) from FWQRC facilitates for third party GMP inspections.

FWQRC To Life Sciences industries can provide tailored support for any of the following GMP compliance issues:

Pre-Health Authority inspection of manufacturing or laboratory facilities

Gap Analysis and action plans for audit readiness (USFDA,EDQM,TGA,WHO,etc)

Gap Assessments against (21 CFR Part 210, 211,Part11,ISO,EDQM,ICH,etc..)

Desk-top audits

Corrective and Preventative Action Recommendations

Development of Policies and Procedures

Staff training (GMP)

Development of action plans and response to deficiencies

Ongoing compliance with current regulations

The above services that will assist in the development and management of a robust Quality Management System

Let our qualified team provide the support needed to achieve GMP excellence with quality as the focus.

Contact us to discuss the options available to best suit your business needs