Audit management services

Audits are crucial to meeting international compliance standards and succeeding in any product development. We offer extensive support to our customers in regulated markets to enable a successful audit based on EU-GMP regulations.

  • 3rd party audits of API suppliers and CMOs
  • Plant audit support for APIs, intermediates and industrial chemicals to verify extent of conformity and implementation of GMP
  • Our audit partners are highly experienced in auditing pharmaceutical suppliers locally and internationally. 
  • We assess the competence of the management system to ensure conformity with GMP requirements. 
  • We investigate unusual events or incidents to determine facts, recreate events, and/or determine causes. 
  • We recognize areas for potential improvement. 
  • Need of the day: remote/desktop audit 

How do we assist?

Executing a pre-audit preparation

Assimilating pre-audit reports through survey, vendor assessment questionnaires and supplier/producer evaluation checklist

Providing logistical support to facilitate audits

Supporting onsite audits through scrutiny of quality and process documentation

Conducting detailed product reviews

Examining change controls and notification systems 

Reviewing certifications 

Conducting follow-ups post audit for audit reports and for deficiencies reported during the audit until CAPA closure

Products audited

Over the past three decades, ExSyn has proficiently managed more than 500 GMP and paper-based audits.