Auditing

⦁ Mock regulatory inspections:
Former regulatory Inspectors can perform mock DRAP, WHO, EMA, EU, MHRA or FDA inspections to assess the readiness of a company to successfully host a regulatory inspection, or as part of an initial gap analysis as a site embarks on preparation for such an inspection.

⦁ GXP audits:
GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) audits are a core specialty; however PV (Pharmacovigilance) GCP (Good Clinical Practice) and GLP (Good Laboratory Practice) audits can also be provided using ex Regulatory consultants.

⦁ Supply chain audits:
The entire supply chain and product life-cycle can be audited from starting material manufacturers, API manufacturers, excipient suppliers, packaging suppliers, clinical development, manufacturers and contract manufacturers. Virtual companies (who also need an excellent Pharmaceutical Quality System, are a particular area of expertise.

⦁ Due diligence audits:
Performed in relation to merger and acquisition activities can be provided. Typically of a shorter duration these audits will rapidly identify potential issues and gaps in relation to current industry and regulatory standards.

⦁ ‘For cause’ audits:
Often performed in response to an incident such as a recall, complaints or adverse regulatory inspection finding.

⦁ Pharmaceutical Quality System audits:
The success of a company is founded on the design and effective operation of its Quality System. FAAZ Auditors can provide an evaluation and assessment of a company’s Quality System and advise on its design so that it is fit for purpose.

⦁ Self-Inspections/Internal Audits:
Are often not performed with the full vigour and robustness they require; An efficient Self-inspection/Internal Audit programme should result in no regulatory inspection findings! How often does that happen? FAAZ Auditors can perform a critical evaluation of the Self Inspection System or ad hoc audits as part of a site/company Self-Inspection system.

⦁ Audit programme management:
FAAZ Auditors can perform all external and /or Self-Inspections on behalf of an organisation. FAAZ Auditors plan and perform the audits against the annual audit schedule freeing up company resource whilst ensuring that all of your audits are performed in accordance with the latest regulatory expectations.