Good Manufacturing Practices Audit:
At Zenovel, we prioritizes maintaining high quality standards in the pharmaceutical supply chain through GMP audits, ensuring compliance with health authority regulations, industry best practices, and current standards. As regulatory requirements evolve, there’s a growing need for enhanced vigilance and Quality Risk Management during the audit process. Manufacturers are mandated to conduct regular GMP audits of their suppliers or employ certified third-party auditors to ensure compliance with pharma product criteria and gain valuable insights into the quality control of their processes and products.
What we do in GMP Third Party Audit Audit?
The duration of a GMP audit depends on factors like the manufacturing process’s complexity, the organization’s size, and compliance record. Basic audits take one to three days, while more complex sites may take up to 10 days. Audits can be conducted in-person, electronically, or through desktop assessment.
For instances, GMP audit can be
- Self-assessments: consistent internal evaluations to guarantee continued adherence.
- Frequent Evaluation Audits: these include warehouses/transportation, contract testing labs, CDMOs, active ingredients, excipients, and packaging components.
- Preliminary Selection Audits: assessment of new service providers and suppliers prior to on-boarding.
- Pre-Inspection Audits: getting ready for inspections by regulatory bodies.
- Gap Assessment Audits: confirmation of compliance with industry best practices and GMP requirements.
- For Cause audits: are those that are prompted by serious problems with compliance or quality.
- Due Diligence Assessments: Thorough analyses carried out during strategic alliances, mergers, or acquisitions.
After conducting an audit, we provide a comprehensive report detailing the findings and recommending areas for improvement.
Key Advantages of Third Party Audit
- Risk Mitigation and improved compliance: Third-party audits identify potential hazards and compliance issues in your supply chain, enabling businesses to prevent costly regulatory proceedings, product recalls, and brand harm early.
- Unbiased Evaluation: It provides an impartial and objective evaluation of production procedures and quality systems, ensuring transparency and accuracy despite potential organizational biases.
- Global regulatory competence: Third-party auditors, with their global GMP knowledge, can help businesses stay compliant in various markets, despite the challenges of managing regulatory environments.
- Supply chain transparency and integrity: Third-party audits ensure supply chain compliance with GMP regulations, promoting transparency, maintaining production integrity, and enhancing supplier relationships.
- Operational efficiency: The quality of products and operational effectiveness can be significantly enhanced through early detection of inefficiencies and third-party audits.
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Implementation of Third Party Audit
Why can you rely on Zenovel?
- We involved teams of former regulatory agency inspectors and industry professionals, offers comprehensive audits to pharmaceutical businesses, identifying GMP compliance gaps, understanding risks, and implementing remedial strategies, ensuring a comprehensive and impartial audit experience.
- Pre-inspection audit: It involves assisting with CAPA plans, identifying compliance gaps, implementing mitigation measures, and providing employees mentorship to ensure inspection preparation for regulatory authority inspections.
Organized Auditor Training: We offer comprehensive training programs for auditors at all levels, tailored to their specific needs, covering technical pharmaceutical processes, controls, and auditing techniques.
Ready to enhance your supply chain’s compliance and efficiency?
Contact Zenovel today to learn more about our Third-Party GMP Audit services and how we can help you navigate regulatory standards with confidence.
