Audit of suppliers of pharmaceutical substances and auxiliary materials

Auditing suppliers of pharmaceutical substances and excipients is an important procedure to ensure product quality and safety. It involves a comprehensive assessment of suppliers to verify their compliance with established standards and requirements, thus minimizing the risks associated with the quality of raw materials.

What's that?

Why do you need a supplier audit?

1. Quality Assurance: Ensures that the substances and excipients supplied meet strict quality standards and are free from impurities or defects that could affect the final product.
2. Regulatory Compliance: Regulatory bodies such as FDA and EMA require pharmaceutical companies to conduct regular audits of their suppliers. This helps to ensure compliance with international standards and avoid legal and financial problems.
3. Risk mitigation: Audits help identify potential risks early on and take the necessary steps to address them, helping to reduce the likelihood of problems in the manufacturing process.
4. Increased trust: Companies that conduct regular supplier audits demonstrate their commitment to ensuring the quality and safety of their products, which increases the trust of consumers and partners.

Supplier audit process

1. Preparatory phase: This includes gathering information about the supplier, analyzing their production processes and quality control systems. This step identifies key areas to be audited and formulates audit objectives.
2. Conducting the audit: Visits to the supplier's manufacturing sites, assessing documentation, interviewing key personnel and analyzing data. Auditors verify compliance with all aspects related to product quality and safety.
3. Final Report and Recommendations: Upon completion of the audit, a detailed report is prepared, including identified nonconformities and recommendations for corrective action. The supplier is given time to implement corrective actions and re-audit if necessary.

Key audit objective

Key audit objective

Verification of compliance of suppliers of raw materials with the requirements of the customer and regulatory documents

Advantages of working with professional auditors

• Expert opinion: Professional auditors have in-depth knowledge and experience in auditing suppliers of pharmaceutical substances and excipients, which allows them to effectively identify and analyze potential problems.
• Objectivity: External auditors provide an independent assessment, avoiding bias and providing an objective picture of suppliers.
• Timely identification of problems: Regular audits help detect and correct potential nonconformities in a timely manner, reducing the risk of serious problems and improving the overall efficiency of the production process.