Audits
Quality audits ensure medical and pharmaceutical standards in accordance with regulatory requirements. Professional quality audits add value; promoting continuous improvement in quality. Gsap provides a wide range of internal, external and site audits. These audits are a necessary quality tool to meet GMP requirements, authorize suppliers, as well as to prepare for audits from the regulatory authorities (FDA, EMA, NB, ISO and more).
Internal Audits
Quality inspection
Gsap experts can evaluate the inspection readiness of a company and the robustness of their quality system. After implementing numerous quality systems and attending hundreds of inspections, we know how to implement the appropriate system to suit your product’s risk, your organization and the specific regulatory requirements. We will prepare a relevant checklist, assign the most knowledgeable expert in your field and propose the optimal improvement program.
Custom made audits-according to customer’s request
Special audit requests (not according to specific guidelines) arrive usually from healthcare companies’ CEOs and quality managers in order to understand and plan their human resources or by VCs that want to evaluate companies targeted for acquisition. Gsap’s management team deals with many special audit requests, examples include: evaluation of validation policy and execution, evaluation of batch release process, evaluation of prevention maintenance processes and more.
External audits
Regulatory authority mock audit
Gsap experts can evaluate the inspection readiness of a company and the robustness of the quality system before a regulatory inspection. After implementing numerous quality systems and attending hundreds of inspections we know how to implement the right system to help you pass the regulatory inspection with flying colors. We will prepare the relevant check list, assign the most knowledgeable experts in your field and propose the optimal, fast and practical improvement program.
Suppliers auditing
Pharmaceutical and medical device companies are highly dependent of suppliers. The regulatory authorities see your suppliers as an extension of your company’s operations and thus, the responsibility of your company. Gsap experts can help you to maintain suppliers’ compliance by executing expert inspections in the relevant field, such as: API production, compounding & filling sites, PCB production, assembly, different specialized laboratories, and so on.
