Conducting a GMP Supplier Audit
In order to reduce the cost, pharmaceutical companies have increasingly become dependent on their suppliers/outsourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes. To gain an insight into supplier processes and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to PIC/S GMP code, it is your sole responsibility to ensure that the supplier’s manufacturing processes, analytical tests and examinations are carried out reliably by the supplier and are in compliance with the applicable standards and regulations. After the audit, supplier must provide an appropriate corrective action plan with measures that will be implemented by the supplier within a defined timeframe to the manufacturer.
Supplier Audit Checklist
Looking into the details of supplier’s quality systems should be utmost priority during a GMP supplier audit. Focus on identifying the non-conformances in quality process, production, packaging process, engineering changes, shipment and invoicing at the vendor’s site.
Training and Accountability
All the high quality machines, processes and tests may well go down the drain if the vendor’s workforce is not fully prepared to implement them. Make it mandatory that the supplier has appropriate training program for new employees to meet the current GMP quality requirements. Accountability is the key if you want the supplier to maintain integrity and consistency. If management comes forward to own the responsibilities for routine issues, employees will be encouraged to perform their parts in a dedicated manner.
A well-organized and clean manufacturing facility reduces the chances of hazards and contamination. By auditing the vendor’s workplace, you can have a fair idea of how seriously the employees take their work. Do they pay attention to details? Organizational culture in the workplace apprises you of various facets of the supplier and may improve your confidence in them.
Your suppliers also rely on other suppliers for raw materials to manufacture goods for you. When conducting a GMP supplier audit, evaluate your supplier’s access to various supplies. Because if your vendor fails to get an item from his supplier, eventually you will not get your product on time.
Steps-by-Step Guide to GMP Supplier Audit
Supplier auditing is a necessary part of quality management system. Before signing a deal with a new supplier, you should conduct a thorough GMP supplier audit to ensure that the supplier always delivers high quality and standard products.
Follow these steps to successfully perform the GMP supplier audit.
1 - Schedule a time for audit by contacting the supplier. Observe how they respond to your proposal of performing supplier audit. Allow them certain time for preparation; it would benefit both the parties. Inform the vendor on who the lead auditor will be and what resources would be required.
2 - Prepare the outline of your audit plan and review the vendor’s performance history. Generally, audit plan depends on reason behind conducting supplier audit. For example, if a discrepancy has been reported in the production area, you should spend more time evaluating it.
3 - Conduct the audit as scheduled, at the same time keep the supplier’s schedule in mind. Their activities shouldn’t be hindered. Take a note of how the supplier’s team welcomes and greets you because thisreflects the ethics and principles of the vendor.
4 - Take an inspection tour to the manufacturing premises, have a close look at the equipments and safety issues, pay attention to the GMP operations and waste disposal. Do not miss the supplier’s shipping policies, workforce strength and attitude of managerial as well as non-managerial staff.
5 - Check the supplier’s invoices to know if they are charging you accurately. There should be no inconsistencies in unexplained miscellaneous charges, shipping and transportation fees. Keep taking notes throughout the process. It will help you when writing evaluation report and addressing the issues.
6 - Write down the complete evaluation report and support your points with evidences. These documents should be accompanied by your recommendation to resolve the issues. Discuss these with the supplier’s team because they may also have certain concerns.
When conducting the GMP supplier audit, keep your vendor as a partner.