The pharmaceutical industry is responsible for a large part of the world’s economy, while positively impacting the lives of millions. This high-regulated sector has strict quality and safety requirements, making product excellence fundamental.
Assessment of compliance levels with Good Manufacturing Practices (GMP) is an essential tool for guaranteeing that the services and inputs contracted comply with the regulatory and quality standards needed to produce reliable drugs for patients. This means that running supplier audits is crucial and companies should regularly assess their suppliers’ performance and communicate with them effectively.
Why is supplier auditing so important in the pharmaceutical sector?
If low quality raw materials are used, then undesirable side effects on patient health can compromise the drug’s efficacy, leading to serious consequences for both the company and the consumer. Nevertheless, even with a rigorous supplier selection process, the only way to assure final product quality is through periodic audits. This is why supplier audits are essential in the pharmaceutical sector for a variety of reason.
Product safety – Supplier audits help guarantee that pharmaceutical products acquired are safe and effective for consumers.
Risk reduction – Supplier auditing helps minimize the risk of error in the supply chain, such as contamination or adulteration of raw materials.
Consistent quality – Supplier auditing helps ensure consistent quality of the pharmaceutical products acquired, because suppliers need to comply with the same quality standards in every delivery.
Compliance with safety requirements – Supplier audits also help to ensure compliance with safety requirements, including occupational safety and environmental protection.
Protect the company’s reputation – Supply chain interruptions from inadequate suppliers can negatively impact a company’s reputation. Supplier audits help to ensure the company is only working with reliable and reputable suppliers.
What are the benefits of doing supplier audits?
Performing audits on the suppliers of pharmaceutical inputs can be beneficial in several ways:
Quality assurance for products – Assessing the supplier’s production process makes it possible to identify potential problems and risks in relation to input quality. This lets a pharmaceutical company certify that it is acquiring high-quality products.
Less risk of interrupting the production chain – Identifying risks in the supplier’s production process means the company can take preventive measures to avoid production chain interruptions. This can prevent production delays or even a lack of inputs.
Regulatory compliance – Supplier audits are common practice at pharmaceutical companies, especially in relation to regulatory requirements. The company can therefore certify its compliance with regulatory agency requirements, guaranteeing that suppliers meet the standards applicable to the pharmaceutical industry, such as Good Manufacturing Practices (GMP).
Better supplier relations – Performing periodic audits can help to establish a relationship of trust between the company and the supplier, which can lead to long-term mutual benefits.
Lower costs – Identifying problems in the supplier’s production process can help the company implement improvements to its own production, which can result in lower costs and increased efficiency.
How can supplier audits be more efficient?
To make audits of suppliers of pharmaceutical inputs more efficient, it is essential to take the following measures:
- Establish criteria to select suppliers, based on aspects like quality, delivery times, and compliance history.
- Carry out a risk analysis to prioritize the suppliers with the biggest potential impact on final product quality.
- Define an audit program, using a frequency and scope suited to the company’s needs.
- Use an audit checklist that includes mandatory items in regulatory standards, as well as specific aspects related to the product in question.
- Train the team responsible for the audit, focusing on good auditing practices and applicable regulatory standards.
- Do the audit in person, to directly identify the supplier’s manufacturing process and quality control conditions.
- Document all of the information collected during the audit, such as evidence and deviations found.
- Put an action plan in place to deal with all of the deviations identified and monitor the corrective measures implemented by suppliers.
- Keep supplier audit and performance documents up to date, for use in decision-making on partner continuity.
These measures make it possible to ensure the quality of pharmaceutical inputs and minimize risks related to failures in regulatory and public health compliance. Implementing a solid supplier management system, including regular audits, performance assessments and effective communication, can help pharmaceutical companies mitigate risks and improve the overall quality of the final product.
I hope that these steps help you have an effective supplier audit. If you would like to learn more, see more of our content: