GMP Audits & Self Inspections

GMP Audits

Our GMP Consulting Specialists are trained to carry out audits to assess compliance with GMP (Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Points). Our GMP Specialists can lead audits on your behalf or offer additional expertise to supplement your in-house audit teams.

In some cases, Health Canada permits the use of GMP Consultants to carry out third party audits for the purpose of Establishment Licensing. If you are unable to obtain acceptable evidence of GMP compliance from your suppliers, our GMP trained auditors are qualified to audit your foreign sites. We then provide you with a written audit report that meets Health Canada’s expectation for the purpose of attesting to compliance with Canadian Drug GMPs. This enables you to have your foreign sites approved as GMP compliant on your Drug Establishment License (DEL). We can also work with your firm in a consulting capacity in order to address any non-compliances and help your firm become GMP compliant.

In some cases, International Regulatory Authorities look for an attestation of compliance to Canadian GMPs. Our trained GMP Consultants are qualified to audit manufacturing, packaging, labelling and testing sites to determine if these sites comply with Canadian GMP requirements.

A DSA GMP Consultant also offers experience in auditing international clinical trials with respect to manufacture, packaging, labelling, and distribution.

Additionally, DSA Consultants can handle drug GMP audits of your contract fabricators, packagers/labellers, testing laboratories, importers, distributors, or wholesalers. Prior to entering into a business relationship with a new party, use our services for an independent due diligence assessment. Using our GMP auditing services provides you with an impartial assessment of the firms capabilities and the status of the GMP compliance. This avoids costly surprises following company or product acquisitions.

Contact us to find out more about how DSA’s GMP Consulting Specialists can be of assistance to you.

Self-Inspection

One of our trained Quality Consultants can develop, implement, manage and/or administer your self-inspection programme. A DSA Quality Auditor can carry out the full self-inspection programme (audit of the Quality Control function) to ensure compliance with the Good Manufacturing Practices (GMP) and requirements for Annual Product Review. With the 2009 GMPs, many companies are unsure of how to meet requirements for “Annual Product Quality Review”. A DSA Quality Consultant can work with your firm to develop SOPs for “Annual Product Quality Review”. We can also handle the review on your behalf by reviewing your documents at your site and generating a compliance report for you. DSA’s experience with Health Canada Inspectors gives us the insight to audit your documentation in a manner that helps ensure your compliance.

Additionally, we can handle related activities for GMP quality audits of your contract fabricators, packagers/labellers, testing laboratories, importers, distributors, or wholesalers.

Prior to entering into a business relationship with a new party, use our services for an independent due diligence assessment audit. We will provide you with an impartial assessment on the firm’s GMP compliance status which can help your firm make business decisions regarding potential business relationships.

Our auditors are ASQ certified and are trained to carry out audits to assess compliance with GMP (Good Manufacturing Practices) and HACCP (Hazard Analysis Critical Control Points). We can lead audits on your behalf or offer additional expertise to supplement your in-house audit teams.

Contact us to find out more about our GMP Consulting Services and how DSA can manage your audits and self-inspection activities.

Regulatory Submission Compliance Audits

Is your firm in compliance with the terms of your NoC (Notice of Compliance) and the commitments made during your submission review or marketing authorization? Is your regulatory filing current and up-to-date? With the revocation of “sufficient time”, many companies are finding that their regulatory filings have not been maintained and are looking for regulatory submission audits to assess the need for subsequent filings with Health Canada or other regulatory authorities. DSA handles all types of submission audits to assess compliance with both the market authorization and current regulation.

Please Contact us for more information on Regulatory Compliance Audits. To receive our white paper on marketing a therapeutic product in Canada, please click here.