GMP (Good Manufacturing Practice) audits are the foundation of quality assurance in the production of medicinal products. Our GMP audits focus on assessing the compliance of production processes with international standards. We check whether the place of manufacturing, quality control or storage of the medicinal product meets the relevant GMP requirements. During the audit, we verify all documentation from receipt of raw materials to manufacturing, quality control, personnel management, storage as well as release to the market. As a result, companies can be assured that their products meet the highest quality requirements and are safe for consumers. GMP audits are key in identifying potential risks and eliminating non-compliance. By verifying compliance with GMP, potential deviations from standards can be detected and necessary corrections can be made. These audits are not only a tool to improve quality, but also part of building reputation and trust among customers.
The GMP audits we perform are tailored to each client’s specific business. Regardless of the size of the company or the type of production, our services help maintain the highest quality standards. Regular GMP audits are an investment in the quality and safety of medicinal products, which translates into market success and customer satisfaction.
Our GMP audits include:
- Stationary audits,
- Hybrid audits,
- Remote audits,
- Support in preparation for the inspection conducted by the Agency,
- Support in the development of CAPA.
Benefits of GMP audits:
- Ensuring compliance with international standards
- Identification and elimination of potential threats
- Improving production processes
- Increased customer trust
- Building the company’s reputation
- Supervision of the supplier/subcontractor/contract manufacturer
- Adaptation to the specific nature of the client’s business.
