Performing effective, value-added GMP audits is one of the most challenging activities, but without doubt one of the most important.
How can QVA Help with GMP Audits?
QVA has 18 years’ experience auditing quality management systems and offers customized and value-added auditing solutions everywhere you do business. QVA will perform independent internal GMP Audits on behalf of clients to determine quality system compliance, particularly for clients lacking the resources or experience to perform their own audits. Having a third-party auditing program helps to reduce non-conformances, regulatory actions, poor product quality, loss of manufacturing licenses, and product liability risk. Clients often call upon QVA to audit potential contract manufacturers or suppliers to detect possible liability situations. This allows clients to correct questionable situations – or decide to use another supplier.
I provide a wide range of services related to GMP Audits, including:
Baseline assessments (gap analysis) – Through this audit I will determine your current level of compliance and identify any required improvements to meet the state mandated cannabis manufacturing licensing requirements.
Internal audits – I provide internal auditing services which allow for an independent review of your full quality system.
Supplier Audits – As part of your internal audit, monitoring your critical suppliers is both good business practice and a regulatory requirement. It is your responsibility to ensure proper cannabis manufacturing processes even if you rely on subcontractors for your manufacturing operations. I will conduct audits on your behalf to assess whether your critical suppliers are adequately addressing your requirements in accordance with the applicable regulations.
All GMP Audits will involve several steps including audit preparation, implementation, reporting, completion and follow-up, if required. Audit reports include executive summaries, findings compared to requirements, regulatory significance, and recommendations for corrective action. Once an audit has been completed, I will offer additional services for implementing corrective actions.